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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

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.

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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

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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