David Swanger

David Swanger

David Swanger leads marketing at Medable and is passionate about applying technology in novel ways to solve some of the world’s biggest challenges.

Recent posts by David Swanger

4 min read

March Pulse Check on Decentralized Clinical Trials - Overcoming DCT Implementation and Planning Obstacles

By David Swanger on Apr 1, 2021 1:26:24 PM

Throughout 2021 we’ll take a look at the latest developments in the realm of Decentralized Clinical Trials. Read this monthly roundup to discover the latest trends, insights, and modalities of decentralized clinical trials.

Over the past year, we at Medable have seen tremendous growth in Decentralized Clinical Trials (DCT’s). In 2020 DCT’s moved from edge case to main case. And as we look back on the first three months of 2021, it’s clear that there is tremendous interest across life science organizations to adopt DCT’s on a widespread level.

Essentially, the question life science organizations are most often asking when it comes to DCT’s is no longer: “Why DCT’s?” 

Today the question is “How?”

How do study teams work together to implement, deploy, and manage a DCT? How do they customize it for their specific treatment, protocol design, and therapeutic area? 

And once digging into specifics several other questions emerge such as:

Can we decentralize studies into therapies with higher toxicity profiles, such as those in oncology? How do we ensure older participants are able to successfully use eCOA and DCT technologies? Can we use a remote eCOA and DCT approach without the reliance on multiple vendors and disjointed solutions? 

In March at Medable, we focused on demystifying how to overcome DCT Implementation and Planning Obstacles. 

On March 8th, 2021, leaders from Medable, Janssen, J&J, PPD, Mallinckrodt Pharmaceuticals, and UCB led a Reuters featured webinar focused on “Overcoming Perceived DCT and eCOA Adoption Hurdles.” You can view the webinar here.

Earlier on March 4th, Medable’s Ali Holland helped attendees navigate how to utilize a single platform for virtually all sensors and wearables, as they continue to become hallmarks of DCT’s. While these sensors and wearables can bring additional quality of life, disease state, and demographic data to complement traditional primary endpoints, managing them in a disparate manner can introduce complexity and risk to a study. To learn more, you can view the webinar here.

Finally, on March 29th as part of Decentralized Clinical Trials Digital week, we delivered the opening keynote of the event delivering a webinar:

“Decentralized Trials Have Arrived: How to Successfully Implement Decentralized Trials.” You can view the webinar here.

 

Medable in the News in March 2021

During March, Medable was also featured in several news articles with a focus on highlighting how different stakeholders in the clinical trial process can successfully adapt to a Decentralized Clinical Trial approach. These articles focused on several key stakeholders, including study teams, patients and legal teams.

Clinical Trials and Tribulations

Our own Parag Vaish, Chief Product Officer, sits down with The Medicine Maker’s Maryam Mahdi to talk about pharma’s adoption rate of new clinical trial technologies, including DCT’s

Medable Advisory Council Works to Amplify Patient Voice, Inclusivity

Medable Patient Advisory Council (PAC) member Allison Kalloo, and our own Reem Yunis, Head of DEI at Medable were interviewed by Outsourcing Pharma on how we can work together to bring diversity, equity, and inclusion to modern trials.

As Clinical Trials Move Off-Site, Legal Teams Prepare for New Challenges

Andrea Sanchez, Vice President, Legal & SaMD at Medable covers the changing legal landscape, as more trials at home create new types of legal challenges

International Women’s Month

March also marked International Women’s Month. During March, Medable founder and CEO Dr. Michelle Longmire sat down with Made By Women, a podcast about women who are transforming the world in unique ways. In the conversation with host Kim Azzarelli, Michelle shared her journey to entrepreneurship and how women can support each other’s ventures.

You can view the blog and listen to the podcast here!

https://blog.medable.com/womens-history-month-ceo-michelle-longmire-explores-medables-quest-for-discovery-on-made-by-women-podcast

Why We Joined Medable? And Why You Should Too.

Curious as to how and why people are joining Medable? In March Anushka Gupta, a Data Scientist, and Snadeep Jutla, a Digital Project Manager, both shared their excitement as to why they joined Medable, and why you should too. 

You can read them here!

Looking Forward

As March turns to April, we at Medable will continue to help sponsors, CRO’s, sites, and patients to successfully navigate their transition to Decentralized Clinical Trials (DCT’s). In April we’ll focus on how a DCT Platform approach enables each clinical trial to establish bespoke workflows, blending technology-enabled services to suit the protocol, sites and patients. This results in accelerated recruitment, increased patient retention and quicker progress to database lock. We are the first platform to enable the entire patient journey to be digitized from recruitment to closeout, across activities both remote and in-person.  Our platform is architected for ease of integrations, such that we partner with best-in-class wearables/devices and integrate the set-up, training and data flow into the patient and site-facing workflows where possible. This enables Medable to offer the most flexible decentralized clinical trial platform allowing sponsors to scale up and down their hybrid capabilities to suit their unique studies.

If you’d like to see the Medable Platform in action, sign up for a demo.







5 min read

February Pulse Check on Decentralized Clinical Trials: Entry Points to DCT’s

By David Swanger on Mar 2, 2021 11:43:35 AM

Throughout 2021 we’ll take a look at the latest developments in the realm of Decentralized Clinical Trials. Read this monthly roundup to discover the latest trends, insights, and modalities of decentralized clinical trials.

This past February, our blog focused on the various entry points involved in moving trials to a fully Decentralized Clinical Trial (DCT). Although our industry is gaining familiarity with this new approach to clinical development, several questions remain. One of the most important we find our customers asking is “Where do I start?”. 

In February we dug into a couple of key entry points. The first has to do with electronic clinical outcome assessments (eCOA’s). The second has to do with enabling the voice of the patient.

Before we look at our recap, let’s first define Decentralized Clinical Trials (DCT’s) for those who have found this blog as their entry point in education. DCTs differ from traditional clinical trials by bringing the trial to the patient through a combination of technologies (eConsent, eCOA, TeleVisits, Sensors & Wearables), mobile/local healthcare providers, and enabling the voice of the patient. Thus, there are a variety of modalities that can be used as an entry point in decentralizing a trial, whether through consent, outcomes reporting, or site visits. Regardless of the point of entry, the solution must be tailored in a flexible and modular manner to fit the unique needs of an indication, therapy, or patient population.

This past month we published two blogs on how to successfully operationalize eCOA’s.
 

Our own Dr. Ingrid Oakley-Girvan began the month by delving into:

 The Language of COA’s

In the blog, Dr. Oakley-Girvan dives into the four categories of Clinical Outcome Assessments spanning Patient Reported Outcomes (PRO), Performance Outcomes (PerfO), Clinician Reported Outcomes (ClinRO), and Observer Reported Outcomes (ObsRO). She also examines the suitability of each outcome assessment for decentralization and how each can be measured remotely through various technologies and processes.

Next, our own Dr. Reem Yunis took a deeper look into the most popular form of eCOAs, Electronic Patient Reported Outcomes (ePRO):

I Want To Tell You in My Own Words: Patient Reported Outcomes

In the blog, Dr. Yunis charts the path our industry has taken from paper based patient reported outcomes to electronic. Important factors she highlights for consideration in the blog include the modality and device type a PRO is presented on as well as the challenges presented in achieving compliance. Both are factors which are heavily influenced by patient engagement and compliance.

In February we also continued to expand how we can give voice to the patients and caregivers that are critical to DCT adoption.
 

Over the past year Medable has been expanding it’s Patient Advisory Council and this February we announced the following:

Medable Expands Patient Advisory Council to Drive Patient-Centered Improvements in Clinical Trials

Our four new PAC members include:

Sumaira Ahmed: a marketing director at Brigham & Women’s Hospital in Boston. Shortly after being diagnosed with sero-negative Neuromyelitis Optica Spectrum Disorder (NMOSD) in 2014, she founded The Sumaira Foundation to raise global awareness and find a cure for NMO. 

Gaurav Dave, MD: an Associate Professor of Medicine, Associate Director of the Center for Health Equity Research, and Director of Abacus Evaluation Consulting at the University of North Carolina at Chapel Hill. 

Allison Kalloo, MPH: a patient recruitment specialist and the founder of Clinical Ambassador, iParticipate and CliniVIVRE aimed at expanding minority access and impacting diversity, equity and inclusion in clinical research. 

Paul Kidwell: a Boston-based public relations and patient advocacy consultant, providing media relations and patient engagement support for biopharmaceutical companies, and a rare disease podcaster. 

Additionally, several of our PAC members made important contributions to expanding the voice of the patient this past February including:
 

Wither the Caregiver. Phama and Healthcare’s New Best Friend 

In this blog Mr. Kidwell highlights some of the unsung heroes of our healthcare system: caregivers. He shares his personal experience of being thrust into the role. Just as “nobody expects to get sick until they do, for caregivers, this sentiment is exactly the same. The role and its inherent demands are never part of a person’s thinking”

Our own Sumaira Ahmed was also featured on a podcast:

Illuminating NMO: The Power of the Patient Voice

During the podcast, Ms Ahmed shares her story around Neuromyelitis optica and how she started a foundation that's mission is to amplify NMO patient voices and raise money for researching a cure.

Finally, February marked Black History Month and with it two of our patient advocates commemorated the life and legacy of Henrietta Lacks:

Getting Her Say: The Immortal Legacy of Henrietta Lacks

Allison Kalloo and Sumaira Ahmed investigated the legacy of Henrietta Lacks through different prisms, one focused on her impact on medical research and the other on how betraying public trust can have far-reaching and longstanding implications that we will continue to confront for some time.

Giving voice to the patient perspective will be critical to the ongoing success of Decentralized Clinical Trials (DCT’s). And we at Medable are honored and humbled by the work members of the Patient Advisory Council do every day to make these voices heard. Doing so is critical to entering DCT’s with the right perspective. 

As February turns to March, we at Medable will continue to look forward to how we can continue to operationalize DCT’s and help patients, sites, CRO’s, and sponsors to realize the full benefits of this powerful new modality of clinical research. In March we’ll turn our attention to overcoming implementation and planning obstacles related to DCT’s. 

Next week on March 8th, Medable is proud to participate in a Reuters webinar that will highlight how to:
 

Overcome Perceived DCT and eCOA Adoption Hurdles

 

Topics: decentralized trials PAC eCOA
5 min read

January 2021 Pulse Check on Decentralized Clinical Trials: Looking back on 2020 and at What Lies Ahead in 2021

By David Swanger on Feb 5, 2021 11:10:12 AM

Throughout 2021 we’ll take a look at the latest developments in the realm of Decentralized Clinical Trials. Read this monthly roundup to discover the latest trends, insights, and modalities of decentralized clinical trials.

2020 was a pivotal year for those of us who work in clinical development. Covid-19 threw the ultimate curve ball to patients, investigators, CRA’s, and just about everyone else who contributes to ensuring that clinical trials are reliably executed. Suddenly the status quo of asking patients to visit a clinical site for the lion’s share of scheduled assessments was no longer tenable. And as a result our industry turned to Decentralized Clinical Trial (DCT) methodologies for both the continuity and rescue of existing studies as well as the design of new ones.

As we entered 2021 we’ve observed a subtle and important shift in the thinking of many of the stakeholders we interact with on a daily basis. Rather than asking “why” a DCT makes sense, individuals have moved beyond this, now asking “how” to implement one. 

Medable started the month by sharing lessons learned in how we successfully deployed DCT’s in 2020. We also started to look forward to how clinical trials could be reimagined with DCT’s serving as a new foundation. We covered these topics in depth at JPM’s Annual Healthcare conference by  leading five different sessions at the conference. You can view each of the sessions here:

The Digitalization of Clinical Trials

Michelle Longmire Founder and CEO,  Medable,  Maria Fotiu Executive VP of Decentralized Solutions, Syneos Health, Cathy Gao – VP, Sapphire Ventures, Juliet Moritz – COO, Illingworth Research - 

Hindsight is 2020: Lessons learned from DCTs and 2021 predictions

Alison Holland Head of Decentralized Trials, Medable and Craig Lipset Advisor & Founder, Clinical Innovation Partners 

Interview with Rasmus Hogreffe

VP Decentralized Clinical Trial Innovation at Medable 

 Rerouting: How Real-Time Patient Data Will Drive the Future of Healthcare Michelle Longmire with guests: Andy Coravos, CEO, Elektra Labs, Maria Fotiu, Executive VP of Decentralized Solutions, Syneos, Thomas Switzer, Digital Health Scientist, Genentech, Priyanka Agarwal, Director and Head of Digital Health, Myokardi

And finally, you can read VP of Decentralized Clinical Trial Innovation, Rasmus Hogreffe’s overall thoughts and reactions on this year’s JPM’s conference here, on his blog. 

In January of 2021 we also welcomed two important leaders to Team Medable:

Andrea Valente joined Medable as our new Chief Operating Officer to scale the global delivery of Medable Decentralized Clinical Trials. As research and patient care move from the controlled environment of the clinic to the home, focus on operational excellence is paramount. Valente is a proven expert in operationalizing patient technologies in clinical research. She played an early role driving adoption and scale of electronic Clinical Outcome Assessments (eCOAs), one of the first technology categories to interact directly with patients outside of clinical settings. She most recently led development and launch of Oracle’s public health platform to address COVID-19 pandemic response and vaccine trials in the U.S., UK and several developing nations. You can read more about Andrea joining Medable here. 

Parag Vaish joined Medable as our new Chief Product Officer to transform the clinical trial experience for patients and clinicians. As Medable continues to expand its product portfolio, Vaish brings valuable expertise creating products that are intuitive and enjoyable, removing friction from the user experience. During his tenure as head of digital product at Tesla, Vaish led a team of 43, dramatically changing how people buy the Tesla Model 3 through advance deposits, paperless transactions, and personalized home delivery. His team also built a payment system for in-car upgrades. At StubHub, Vaish and team led development of the award-winning StubHub mobile app, featuring a personalized, seamless experience that enabled users to buy tickets in just three taps. At Epocrates, Vaish evolved its mobile app from a 1.0 forms-based product to a modern 2.0 experience to help doctors minimize drug-to-drug interaction dangers. You can read more about Parag joining Medable here.

January 2021 also marked Martin Luther King day. And with this special day in mind, we partnered with Allison Kalloo of the Medable Patient Advisory council to explore the very real disparities in diversity and inclusion in clinical trials. 

Allison was kind enough to share her visceral experiences of growing up and coming of age in the healthcare field dating back to her mom’s experience as a participant in the Civil Rights Movement and her subsequent career as a virologist focused on infectious diseases. This shaped Allison’s experience and led to her becoming one of the foremost thinkers in how to improve Diversity and Inclusion in clinical development. 

You can read Allison’s posts and watch her video interview with Dr. Michelle Longmire here:

 

You Believe in Diversity, Equity and Inclusion? Okay. Show Us.

Blog from Medable PAC member Allison Kalloo

Fit for a King: Bending the Arc of Legacy Toward Action

Blog from Medable PAC member Allison Kalloo

Q&A With Medable PAC's Allison Kalloo On MLK Day 

Video interview with Michelle Longmire, Founder and CEO of Medable, and Medable PAC member Allison Kalloo

In the coming months Medable will be focusing on how to get started with a decentralized trial approach from both a strategic and operational perspective and then turn to looking at the benefits of launching a DCT platform that standardizes how systems, processes, people and data can come together in a predictable way to drive even greater efficiencies in this exciting new realm. 

Stay tuned!

Topics: decentralized trials remote trials PAC medable MLK eCOA
2 min read

Decentralized Clinical Trials Are Already Helping to Increase Patient Access: Strategies to Right-Size Your Next Study with Flexible DCT Operating Models

By David Swanger on Nov 12, 2020 10:24:35 AM

Clinical trials are continuing their march towards greater decentralization after the industry rebounds from COVID-19. A recent study completed by Greenphire Data indicates that this rebound has been faster than expected:

As the Greenphire Data Report summarizes:

While there was a lull in new participant enrollment in the second quarter, new data from Greenphire indicates that new patient enrollment in trials that it provides services for globally has rebounded - up 85% since the trough in April, and has surpassed pre-COVID-19 participant enrollment trends (up 3% since January 2020). This trend reaches across geographic regions, with Europe experiencing a surge in new patient enrollment (up 6% since January 2020) and North America not far behind (up 5% since January 2020).

At Medable, we have seen first-hand that much of this growth in patient enrollments spurred the adoption of Decentralized Clinical Trial (DCT) methodologies. Greenphire found that of those surveyed in the report that:

 “84% of sponsors and CRO’s are actively seeking to increase the use of technology to better support decentralized trials.”

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Greenphire’s Chief Product Officer Kyle Cunningham sums it up well:

The concept of using technology to help create value in a decentralized or hybrid trial environment isn't new per se, but COVID-19 has certainly encouraged wider adoption by forcing everyone to find ways to bring greater connectivity between clinics and patients. 

At Medable, we know that to unlock the value of a decentralized clinical trial approach fully, each study team must assess their unique protocol and analyze which elements of the study schedule---whether consents, outcome assessments, or site visits---can be decentralized. Essentially it boils down to taking a flexible and modular approach.

As an industry, we need to offer greater choice, and decentralization -- in any form -- gives us the tools to do so successfully. Patients benefit from greater choice about where, when, and how they participate in a trial. Sites benefit with ways of managing trials and treating patients. Sponsors and CROs enjoy better data quality with more data capture mechanisms in real life.

Medable’s Mary Costello recently authored an article in Applied Clinical Trials, that provides tips to help research sites implement decentralized trials. It charts the course towards determining the right level of decentralization for a given indication or study, and includes these five tips:

    1. Change management: Know what to expect
    2. Technology: Know what to look for in partners and solutions
    3. Charting the course: Know what to plan and train for
    4. Guiding principle: Know that patients drive process
    5. Cycle of improvement: Know what to measure and adjust

Medable believes that a modular approach to right-sizing a DCT for each unique study will ensure a smoother transition than a one-size-fits-all approach. We start every engagement working with customers to complete oour DCT Readiness Framework to determine the right level of decentralization:

While Covid-19 fundamentally disrupted clinical trials in 2020, there is a silver lining. The groundwork has now been laid for an incremental approach to decentralization. Medable’s readiness framework and modular, integrated platform fosters a flexible approach to each study, promising brighter days ahead for investigators, sponsors, and -- most crucially -- patients.

 

 

 

3 min read

Introducing Medable TeleCOA: A New Path Forward for Patients, Sites, and Sponsors

By David Swanger on Nov 3, 2020 12:57:25 PM

Yesterday we announced the latest addition to our growing portfolio of Digital & DCT offerings: Medable TeleCOA. For full details on the announcement, you can read the press release here. 

At Medable, we’re thrilled about this latest advancement to our flexible and modular platform. Medable TeleCOA combines electronic Clinical Outcome Assessments (eCOAs) with TeleVisits on web and mobile, to enable critical clinical trial outcome capture from the comfort of a patient’s home, anywhere in the world. 

We believe in choice at Medable

That’s why our platform is designed to offer consumer level experiences for patients to engage with their Study team on site or remotely, within the framework enabled for the clinical trial. We offer our apps through multiple modalities, accessible via web browsers. Core to the Medable design philosophy is that patients and site staff should use the same devices that they engage in other daily activities such as shopping and social connections.  

In practical terms this means that a multi-country BYOD approach for the decentralized elements of a trial is now possible. For example, a patient in India could use her personal mobile phone (IOS or Android) and connect directly to the Medable Patient app. When connecting to the app she will initiate a TeleVisit with a Healthcare Professional (HCP) hundreds of miles away. During the TeleVisit, the patient and HCP can complete consents and outcome assessments side by side within the TeleVisit in the same application. Medable TeleCOA is designed with patients and healthcare professionals at clinical sites in mind 

Just as a patient can access Medable TeleCOA on virtually any device with a web browser, so too can a HCP. The means HCP’s can more flexibly incorporate Medabe TeleCOA into the existing collection of systems, workflows, tablets and computers that are currently in use at their site - or even with their own mobile or desktop devices away from the site.

For clinical trials to continue their evolution towards greater digitization and decentralization after the industry rebounds from COVID-19, they must not only be well integrated with the systems that sites and sponsors use regularly but they must also be built with flexibility and modularity in mind. 

The Medable enterprise cloud platform is architected to enable study data to be securely collected, integrated, and harmonized from a variety of devices and sources

Whilst many very well designed point systems exist today, being able to sequence modules together into a seamless and flexible workflow is transformative to the ease and consistency of the user experience. This is really key as it is imperative that digitization reduces and eliminates administrative burden, streamlining our working practices and doesn't just push it down the line to the sites and patients.

Similarly, in this age of data security and privacy awareness, the robust platform enables all the user interface systems to be controlled and managed to collective standards. It’s what allows our partners to securely deploy TeleVisit, TeleConsent, and TeleCOA across a variety of devices in the knowledge that the entire platform conforms to the highest levels of global data privacy and security practices. And in practical terms it means that we’ll work hard to evolve our platform so that it will continue to assist sites and sponsors to better serve the patients that are so critical to the continuing the life-saving advancements of our industry. 

A Site and CRO Perspective

Dr. Robert Bissonnette, MD, FRCPC, founder and CEO of Innovaderm, a leading dermatology CRO, eloquently sums up the potential of the Medable platform to power a variety of digital and decentralized interactions:

“For more than 20 years we have dedicated our efforts at Innovaderm to advancing dermatology research. As the leader of a specialty CRO and as an investigator who has focused exclusively on dermatology, I have seen firsthand how patients and site staff can benefit from decentralized clinical trial methodologies. Medable’s flexible and modular platform means that we can deploy their platform to shift a number of scheduled visits from onsite to remote while still maintaining the patient/investigator relationship that is core to every clinical study.”

Medable is hosting a panel webcast that includes Dr. Robert Bissonnette, Patient Advocate Richie Kahn, and Dr. Michelle Longmire on Wednesday November 18 that will explore how Medable TeleCOA was designed in conjunction and for the benefit of patients, sites, CRO’s, and sponsors: “eCOA in a Decentralized World: Enable Remote Collection of Outcomes to Improve Study Access and Engagement.”


Register for the webcast here: https://www.medable.com/telecoa-webinar

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Topics: DCT TeleCOA
3 min read

Why I Joined Medable: Putting Patients (and Clinicians) at the Center of the Trial Experience

By David Swanger on Oct 9, 2020 1:36:26 PM

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Clinical Development rapidly advanced this past decade. New endpoints and measures covering genomics and devices emerged. New design methodologies like adaptive trials and basket trials gained acceptance. And new advances in clinical operations in areas like risk based monitoring improved safety and efficacy.

In spite of substantial progress, several challenges remain. Today patient access and patient retention persist as the costliest and most time consuming challenges our industry faces. We’re all familiar with the statistics and persistent challenges they underscore. A relatively recent analysis of ClinicalTrials.gov data, “Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination” underscores the challenges surrounding patient participation in clinical trials:

The analysis finds that of the studies that were terminated in the ClinicalTrials.gov database, 68% were done so due to reasons other than data accrual, and of that cohort, 57% were terminated due to an insufficient rate of accrual.

Patient enrollment and retention continue to challenge our industry, and that was prior to our global pandemic. And with precision medicine leading to ever narrower treatments and patient populations, these twin challenges will likely persist.

Improving on these challenges will require a rethink across the clinical development continuum that prioritizes patient experience at every step in the process. Ultimately the sponsors and CRO's that prioritize the patient's experience throughout the clinical development lifecycle will benefit from faster FPI to LPO cycles and a higher proportion of studies with sufficient data accrual to complete the study.

What will putting the patient at the center of the clindev experience look like?

If you ask me, it looks a lot like Medable's Patient, Site, and Sponsor apps.

Each has been developed in close partnership with some of the leading patient advocates, doctors, researchers, and clinicians across clinical development. And with every standardized offering or workflow, Medable has stopped to ask the question, "Does this enhance or hinder the patient (and clinician) experience?"

The result is a fundamentally new approach to clinical development, one that utilizes best practices from Medable’s deep learnings in hybrid and decentralized clinical trials (DCT's). These learnings are then complemented by a commitment to delivering the same consumer-grade experience that delights patients and clinicians when they use their favorite apps like Netflix or AirBnB.

In practice this means that we strive to allow sponsors and CRO’s to right-size their journey to DCT’s by offering a Readiness Framework that clearly shows the progression from light-weight TeleVisit and TeleConsent capabilities to capturing digital endpoints via COA’s, PRO’s, and other forms of digital source data.

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At Medable we recognize that each study is unique. Each covers a different treatment and operates in a unique combination of phase, therapeutic area, regulatory environment, and much more. That means that every Decentralized Clinical Trial (DCT) must fit the unique needs of the patients, investigators, clinical, and regulatory professionals and ensure clinical trials continue to deliver the quality our patients deserve and regulators require.

That’s why I’m so excited to be part of a team of diverse clinical leaders who have the experience, perspective, and passion to help the clinical development process to evolve in a meaningfully positive way. And it starts with our CEO Michelle Longmire, a true visionary who leads by example and is steadfastly committed to ensuring we succeed as a team.

Getting the chance to shape a fundamentally new approach to something as important as drug discovery and commercialization is quite rare. And for that I am grateful to be part of an amazing company that is laser focused on solving the twin challenges of patient access and recruitment. It’s why I joined Medable.

If you'd like to join Medable and help shape the future of the growing DCT movement, we invite you to join us. We are hiring (or will be soon) in just about every department and every geography. I’m looking for strong marketers in product marketing, demand gen/growth, brand/creative, and more. Feel free to apply at www.medable.com/careers.

Topics: careers
2 min read

Decentralized Clinical Trials (aka Hybrid Trials) Are Here to Stay

By David Swanger on Oct 1, 2020 12:33:44 PM

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Yesterday Clinical Research News published a noteworthy article titled: ‘Hybrid’ Trials Will Be Post-Pandemic Norm. The piece provides a solid overview of the state of the Decentralized Clinical Trials (DCT’s) in the “new normal” clinical development leaders find themselves in. Not surprisingly, a recent survey by GlobalData confirms what Medable has observed internally, with 67% of survey participants indicating that they plan to use decentralized clinical trials in the future.

At Medable we’ve seen this shift first hand. In the article, Medable’s Ali Holland confirms that:

          “The shift toward decentralization has already begun, with protocols more often                          designed from the get-go to give participants the option of starting at home for many                of their required study visits rather than traveling to a trial site.”

A key distinction of DCT’s relative to Virtual trials is that DCT’s operate on the hybrid-trial continuum. Whereas fully virtual trials can at times disinter-mediate investigators from patients, DCT’s aim to provide existing patients and investigators with the technologies, workflows, and processes that provide a flexible approach for every sponsor or CRO’s unique study needs. Essential to the success of a DCT or hybrid trial strategy is right-sizing the approach for each study’s unique mix of patients, investigators, lab and clinical practitioners.

Medable allows sponsors and CRO’s to right-size their journey to DCT’s by offering a Readiness Framework that clearly shows the progression from light-weight TeleVisit and TeleConsent capabilities to capturing digital endpoints via COA’s, PRO’s, and other forms of digital source data.

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As Ali Holland puts it in the article:

        “Different studies need different capabilities and Medable’s technology flexibility means             we can meet the unique needs of each study and enable the flow of data consistently               between [any] ecosystem of partners.”

At Medable, our ecosystem does not only include CRO’s, patient recruiting services, device makers, lab networks, and more, but it also includes site and patients. Medable’s Patient Advisory Council ensures that every experience embedded within the Medable DCT platform is assessed and improved by patient advocates. As the article summarizes and Medable’s Rasmus Hogreffe confirms:

“Independent patient advocates on the PAC, meanwhile, will be reviewing design   features of Medable’s technology and proposed study workflows for opportunities to   relieve participation burdens and, as Rasmus puts it, “minimize the gap between theory   and practise.” Incorporating the patient perspective in this way has accelerated patient   recruitment and resulted in “extremely high” patient satisfaction for recent studies.”

If you’d like to learn more about Medable and it’s new TeleConsent offering that makes fully remote informed consents (and reconsents) a reality, sign up for our webcast on Oct 6

 

Topics: decentralized trials Hybrid Trials
3 min read

Insights on Decentralized Trial Execution: An interview with CEO Michelle Longmire in Applied Clinical Trials

By David Swanger on Sep 25, 2020 3:17:21 PM

Last week our CEO Dr. Michelle Longmire sat down with Moe Alsumidaie from Applied Clinical Trials for an interview where they discussed how decentralized clinical trial (DCT) methodologies will transform how clinical trials are executed for years to come. You can read the full interview here on Applied Clinical Trials.

Michelle Longmire
 
 

In the interview Mr. Alsumidaie and Dr. Longmire discuss several important insights and considerations including:

  • An overview of the current DCT landscape
  • How COVID-19 has impacted DCT’s
  • Keys to ensure a DCT is successful
  • Results from DCT implementations
  • How clinical trials will evolve in the future

During the interview, Dr. Longmire highlighted how DCT’s tackle four core challenges that clinical trials have historically faced:

    “The first is patient access. Virtual screening and remote eConsent can dramatically improve access to clinical trials. We’re seeing that these decentralized processes consistently enhance patient recruitment, and we’re developing a baseline dataset for comparison.”

    “The second challenge DCTs help overcome is patient retention. Compared to traditional methods, we see significant improvements when we’re able to reduce site visits that are more focused on basics such as screening, enrollment, consent, and non-invasive evidence and data capture.”

     “DCTs also help overcome issues with data quality, as you mentioned. At a minimum, we want to be meeting the standard for data quality. And in many settings and across various therapeutic areas, we can do that remotely. At Medable, we are starting to think about digital endpoints as a complement to traditional scales and measures. DCTs help with the development of new digital endpoints that are of the same, or better, quality than conventional endpoints. Digital endpoints also provide the opportunity to dial into more disease-based measures for diagnosis and severity.”

    “The fourth main challenge DCTs tackle is efficiency. Traditional clinical trials take much time and come with very discrete processes, as different teams generally do recruitment and consent and evidence generation with diverse strategies and varying technologies. In contrast, we provide a process solution versus a point solution with one interface that drives streamlined workflows and provides seamless decentralized capabilities. This improves overall trial execution efficiency.”

At Medable we are continuing to develop new offerings to address these challenges in a modular and flexible way. Our Decentralized Trial Readiness Framework makes it easy to right size your onramp to a DCT for either an in-flight study or a new one.

During the interview, Dr. Longmire also touched on the importance of shifting physical consents and re-consents to a decentralized approach utilizing technologies to enable the Investigator & patient relationship to be replicated remotely :

     “Consent is another ideal opportunity for decentralization, which also improves the patient experience. There’s a lot that can be managed remotely, and some actions that are better handled in person – like an invasive procedure. There is a push for some of those activities to be conducted in the home, but as a physician myself, I still see great benefit to having the full suite of access that a hospital affords.”

This week we introduced Medable TeleConsent, a new offering that makes fully remote informed consents and re-consents a reality for both patients and investigators. Doing so will potentially save thousands of hours of investigators and patients meeting physically and reducing their exposure risk during the COVID-19 pandemic. To learn more about Medable TeleConsent, sign up for our DCT Panel Webcast featuring Medable’s Ali Holland and Rasmus Hogreff along with Craig Lipset from Clinical Innovation Partners on Oct 6.

Topics: decentralized trials Teleconsent
2 min read

How Hybrid Trials Will Help CRO Market to Grow to $64B by 2024

By David Swanger on Sep 18, 2020 1:24:03 PM

Analyzing Frost & Sullivan report “Hybridization of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019 - 2024”

Frost & Sullivan, the research & consulting firm, recently released an analysis of the CRO market projecting the overall market would grow on a compound annualized basis of 8.2% to $63.83 billion by 2024. This would represent a significant increase from the current market size of $43.03 billion in 2019.

Frost & Sullivan summarizes their findings from the analysis below:

“Due to the impact of the coronavirus, many large pharmaceutical companies have placed new trials on hold and numerous small, mid-size, and large enterprises have suspended ongoing ones, thereby demonstrating the magnitude of the disruption,” said Unmesh Lal, healthcare industry principal at Frost & Sullivan.

“Going forward, to minimize the adverse effect of the pandemic, organizations such as site management organizations (SMOs) and patient recruitment organizations (PROs), that operate traditionally, will have to explore collaboration opportunities with emerging virtual trial platform vendors, eRecruitment providers, and remote monitoring solutions providers to expand the capability to support distributed/hybrid CT models.”

These findings are consistent with what we have been seeing at Medable. Since the pandemic struck, we have helped an array of sponsors and CRO’s from all over the world restart their studies with the use of decentralized study modules ranging from utilizing remote electronic informed consents (and reconsents) to televisits, ePRO’s, and connected devices.

To help study managers right size their approach to hybrid/virtual/decentralized studies we developed a readiness framework that makes it relatively easy to determine the right tradeoff between decentralized trial modules and implementation time:

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Figure 1: Readiness framework for transforming to decentralized trials

As you can see from the readiness framework, just about any study can benefit from lightweight accelerated virtualization whereby electronic consents (and reconsents) as well as televisits are introduced to an in-flight study. Doing so provides HIPAA-compliant options to reduce the number of visits patients and site staff need to make to a clinic. In our post-pandemic world, many sponsors and CRO’s have found that shifting some visits on the study schedule has enabled studies to continue that might otherwise not.

To learn more about Medable’s modular decentralized clinical trial platform, feel free to schedule a demo.

 

2 min read

Apple Watch and Research Kit May Accelerate Digital Endpoint Adoption

By David Swanger on Sep 16, 2020 4:49:14 PM

Devices 051520 (1)

Yesterday, the Washington Post recapped Apple’s fall product launch event:

Apple’s New Watch Draws Attention To Its Health-Care Play: Apple Watch takes the spotlight usually reserved for new iPhones at the September event

The article summarizes Apple’s shift toward services with a focus on the healthcare vertical, especially clinical research through Apple’s Research Kit:

“The Apple Watch is the physical manifestation of the company’s health-care play, and perhaps the most important but least understood prong of the company’s new business model anchored around services rather than gadget sales. The announcement also comes during the peak of a global pandemic in which the conversation about health and technology has accelerated.”

“Apple’s ResearchKit has been used for clinical trials, some of which it was announced to great fanfare. Last year, the company announced three major studies on women’s health, heart health and hearing. In terms of the massive amount of research constantly being conducted by drug companies and in academia, Apple isn’t much of a player.”

“In addition, ResearchKit isn’t a full-service offering. Companies that aim to use ResearchKit for trials still must have the resources to create customized software, and companies such as Thread Research and Medable have sprung up to meet that need. Large drug companies tend to opt for bespoke software with actual medical devices for traditional trials, industry experts say, rather than rely on ResearchKit.”

Medable views the collection of measurable data, direct from patients, in real-time as a key enabler of decentralized clinical trials and effective remote patient oversight. Being able to integrate data, such as ResearchKit, with other contextual data such as Patient Reported Outcomes, enables Medable to offer sites, patients and sponsors a modular suite of data in real time for actionable decisions and patient care management. Use of this data powers patient care initiatives that are now a part of the Medable Decentralized Trial Platform. These patient care initiatives range from enabling HIPAA-compliant workflows, interactions, and televisits between patients, doctors, and study managers using Apple, Android, and just about any mobile or desktop browser.

At Medable we are also excited to see Apple’s continued investment in utilizing the iWatch and iPhone to generate digital endpoints that perform as well or better as devices (like pulse oximeters) that are traditionally used at physician sites or medical labs. While the article notes that there is work to be done in ensuring that the veracity and reliability of these digital biomarker measurements meet or exceed traditional devices and measures, we at Medable are excited about the progress being made across the industry with digitally-enabled devices and measures.

The future is bright for bringing the clinical trial experience closer to a patient’s home and in the meantime helping to bring effective therapies to patients faster in our post pandemic world. If you’d like to learn more about Medable’s Decentralized Trial Platform, feel free to sign up for a demo.

 

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Topics: decentralized trials remote trials