3 min read

Recommendations for Optimizing Televisits

By Mary Costello on Mar 9, 2021 11:09:40 AM

Like many of you, the past months for me have been learning about how to transfer what was my everyday normal life into online mediums.  Some have worked well, while others have fallen short. For instance, I liked virtual workout classes better than I would have expected. However,  a zoom or facetime call with my 86 year old father ends up feeling more sad than satisfying.  However, only this week did I finally experience my first health televisit, with my physician who wanted to discuss a medication change.  

Given that I have spent the last ten months working with sites interested and eager to introduce digital options into their clinical research realm, I felt this was an opportunity for me to observe how the process works in healthcare.

First of all – what worked?  

I was given instructions verbally over the phone by the nurse about three weeks prior on what to do, none of which I wrote down. But, I did remember the basic expectations! “Check that my registration with the on-line portal was up to date, download the app for the televisit and be ready ten to fifteen minutes prior to the appointment.”  

I was prompted the week before to confirm my visit via text. I did receive an email with a link to download the app, and I remembered my apple password without having to retrieve it, and my doctor called me exactly at the time of my appointment.  It was actually great! I know her, seeing her and having her undivided attention for twenty minutes with no waiting ahead of time or hassles of parking etc. went well!  If I had rated my satisfaction with the visit itself, I would have given it a ten, as I did not feel as though the level of care or attention was any way less than an in person visit would have been and the hassle factor was significantly lower.

What didn’t go as well? And, what were my takeaways when incorporating into research?  

I am not sure that the scheduling system / text reminder system was synchronized with the televisit.  I got a prompt on Sunday night reminding me about safe visit procedures on masking and ensuring I was COVID symptom free before coming to the office.  That was the first red flag.  Since I had also gotten the email asking me to download the app, I figured it was just what it turned out to be – two separate systems for communication, operating independently.  

On Monday morning, I saw a missed call from the doctor’s office.  When I returned it, the message said that due to inclement weather, the office was closed that day.  Austin had had its first snowstorm in about ten + years the night before.  There was no way to leave a message and if I chose to call their on call service for a non-emergency, the standard message warned me that I could incur a charge.  At this point, I am wondering whether my physician, since her office was closed, would expect me to reschedule and would take the day off.  

How did it go? 

She called right at the appointed time which had always stayed as a possibility for me.  The other communication ended up being distracting rather than downright annoying as we are still under Stage Five restrictions here. 

However, it did underscore for me that sites need to think about how they communicate and how they create automated reminders and confirmations.  Before implementing tech for a televisit, walk through how all your patient communications will go.  As it was my first televisit, it would have been quite helpful for the office to have a standard. In fact, it could look a bit like this. 

“How to prepare for your first televisit. Here is the link, here are the steps, here is a screenshot, etc.:

In essence, over communicate! 

If you can’t modify your reminder systems, then point out that a patient may receive a reminder making it seem as though they have an in person appointment, and advise them to ignore that message.

As we migrate to the new world order, we must remember that flexibility is here to stay and our goal should be to enhance that experience at every level! 

Topics: telemedicine TeleVisit
7 min read

Foresight is 20/20 - Drug Development's Future

By Jennifer McNary on May 12, 2020 11:32:02 AM

COVID-19 has taken us all by storm, and as a result, much of the world has come to a grinding halt.. As you can imagine, this includes the clinical trial universe, as well. Healthcare resources are being diverted, rightfully so, to combat the pandemic. Suddenly, the world is clamoring for what many in clinical research have aspired to for years - expedited clinical trials leading to treatments to patients faster. Perhaps the coronavirus is gifting us a glimpse into the future of drug development.

Existing Trials: Adapting in Real Time

Globally, there is a pandemic unfolding, rippling across countries and targeting everyone in its path. No one - not Hollywood, athletes, politicians (or their spouses), royalty - is safe, but the eldery and the immunocompromised seem to be particularly vulnerable to the virus causing serious or life-threatening problems. Hospital systems are stressed domestically and on the verge of collapse in other parts of the world. Pharmaceutical companies are beginning to ration their resources, delaying start-up or enrollment to lessen the burden on existing healthcare sites.

For clinical trials that are able to move forward, study teams are scrambling to minimize disruption, both to get existing patients treated and maintaining the trial’s integrity in the face of an unparalleled disruption. Veer too far off course, and current and future patients suffer costly, potentially life-threatening delays. To prevent this, adjustments to standard operating procedures have to be made, whether the slow-to-adopt-change world of clinical research wants to or not.

The FDA has, very quickly, issued guidance on conducting clinical trials during this pandemic. It reads as a sort of wish-list of potential operational advances in clinical research:

  • “Since trial participants may not be able to come to the investigational site... sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented”
  • “The need to put new processes in place or to modify existing processes will vary by the protocol and local situation.”
  • “Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated…FDA recommends consultation with the appropriate review division regarding protocol modifications for the collection of efficacy endpoints, such as use of virtual assessments, delays in assessments, and alternative collection of research-specific specimens, if feasible.”
  • “The implementation of alternative processes should be consistent with the protocol to the extent possible, and sponsors and clinical investigators should document the reason for any contingency measures implemented.”
  • “Changes to policy and procedures could address, but not be limited to, impact on the informed consent process, study visits and procedures, data collection, study monitoring, adverse event reporting…”

 

Think of ways to bring the study to the patient.

Consider how to be flexible.

Engage early with stakeholders.

Accept variance will happen; proactively address, and then record why.

The notoriously reserved clinical research industry is now faced with a decision: adjust your strategy or drop out of the race altogether. Instead of resisting change, adapt and adjust. This is what the future of clinical research will look like - more agile, less rigid; more adaptable, less authoritarian; more personalization, less one-size-fits-all. Most importantly, more human.

COVID-19 Trials: The Future is Now

While existing trials struggle to find their way through this uncertain time, the barriers to clinical research have come down for COVID-19 studies. As of March 23, 2020, there were already five completed studies for COVID-19, and by the time you read this, there’s likely to be more. Notably, there are 113 studies somewhere between “Not yet recruiting” and “Active, not recruiting”, with 62 in recruiting/enrolling/active status. Considering that the World Health Organization wasn’t notified until the very end of 2019 about this new virus, and the average study start-up time is north of 7 months, the swift response to this global pandemic has been unprecedented.

Why has the COVID-19 reaction been so drastically different from “normal”? Was it the life sciences industry changing their standard operating procedures to adjust for the surge in demand for health care? Was it capitalism - and consumers - pushing for a product that a market was literally dying for? Or was it the world collectively realizing that the typical barriers to innovation were not nearly as important as getting treatments or vaccines to patients as quickly and safely as possible? And, importantly, what are we learning about the pace at which clinical research can be done?

First, the caveats - COVID-19 is unlike anything in the modern medical world, so every stakeholder in the drug development process is likely willing to bend on strict adherence to dogmatic Standard Operating Procedures. Many of the trials are for either existing compounds (eliminating the need for a Phase I study) or for diagnostics, both of which accelerate the startup timeline. Physicians and governments are desperate for ANYTHING that could help.

That being said, this is the same clinical research world that regularly regurgitates the following median numbers - seven years, $750 million+, and a success rate of 1 in 5,000, all to get one drug to market. In Duchenne Muscular Dystrophy, it took 8+ years to get exon skipping from mouse models to the approval of Exondys51, the first treatment approved in the United States for DMD. Approval for new sunscreen ingredients languishes, some for the better part of two decades. Even Merck’s hyper-accelerated timeline for Keytruda approval - less than 5 years, an unheard-of number in oncology treatment - was still glacially, frustratingly slow to those who could not access the drug.

 

The COVID 19 trials were enrolled and complete stunningly quick because:

  • Populations of patients were easily identified - this illness could affect ANY and EVERYONE, and potential cases were being brought forward on a daily basis,
  • Time was THE most critical factor; the normal back-and-forth during study start-up was plowed over with compromise,
  • Existing compounds already had safety data, thereby allowing researchers to skip time-consuming early-phase trials, and
  • Pressure was applied universally - from governments, health care facilities, and most importantly, potential patients - to get treatment.

 

The catchphrase “we are all patients” has never been more applicable, and every stakeholder in this specific development process worked collaboratively to make these trials happen, and happen quickly. Technologies already exist that facilitate all of the above FDA considerations (and a slew of new ones are appearing to specifically address COVID-19), yet adoption prior to 2020 was slow and deliberate. Now, the leadership team at Medable has been actively promoting and incorporating decentralization of trials for COVID-19, getting a trial mobile app live in Italy in under two weeks. Drive through testing has shown mobile healthcare is deployable on a large scale. Virtual trials are on the horizon. Clearly, we can do better than we were - we are now.

Key Takeaways From COVID-19

There are numerous positive things to take from the response to the current pandemic and push forward as our world slowly comes out of its hibernation.

 

The US FDA can have flexibility in standards. There remains a shortage of diagnostic tests for the detection of COVID-19. In response, the FDA allowed some labs to begin using validated tests before the regulators had finished their review. We will (hopefully) find out soon if the same acceleration will occur if and when a treatment is found; the FDA continues to work with the public and private entities researching those treatments. It is important to balance the rigorous standards for efficacy and safety with the demands for improved and accelerated healthcare.

 

Guidance that is well-crafted and useful to both patients and sponsors was able to be published in less than 30 days. Too often, this guidance is delayed. The rare disease community has been waiting over 18 months for the new rare disease drug development guidance. The FDA needs more resources to accelerate the rate of product development.

 

Embracing digital medicine and digital health tools will continue to drive healthcare modernization and mobilization, while simultaneously working to remove man-made barriers to effective and efficient clinical research practices. The world is now pilot-testing-by-necessity many of the technologies that sound great in presentations, but have been largely kept on the sidelines by risk-averse trial sponsors and sites.

 

Trial design will continue to evolve, and the use of non-traditional trials - virtual, decentralized, direct-to-patient, whatever they are called - should become more commonplace, as sponsors realize they can reach broader patient populations in more effective ways. Trials will be brought to patients, instead of the other-way-around.

 

Deadly illness is deadly illness, whether a pandemic or a fatal disease. The urgency with which we develop therapies needs to mimic the response and flexibility shown with COVID-19. Let’s not let this crisis - and the accelerated pace of research it forced - go to waste.

Topics: telemedicine decentralized trials
3 min read

Mobilize and Decentralize

By Allison Holland- Head of Decentralized and Remote Trials on May 12, 2020 11:29:18 AM

Taking Action to Ensure Clinical Trial Progress During COVID-19

Why does it take so long to get new vaccines and medicines to market?

 

It is not a new question. But as governments, communities and medical professionals around the world focus their energy and resources on containing the COVID-19 pandemic, it’s being asked with increasing urgency. It deserves – in fact, it requires – our collective attention and effort.

The good news amidst so many troubling headlines is that the technologies we need to improve patient access and experience are here now. The smart application of those technologies can overcome barriers to trial execution and improve data sharing and process efficiency across organizations. Most urgently, those technologies can be used immediately to ensure progress for thousands of clinical trials in an environment where patients are expected to stay at home.

 

Decentralized and hybrid trials – the time has come

At a recent congressional hearing, NIAID director Anthony Fauci gave a frank assessment about the shortcomings of the U.S. system for coronavirus testing: It’s “not really geared to what we need right now.”

The same can be said for our traditional clinical trial model. Limiting trials to a handful or two of physical sites inherently limits patient access, while limiting interaction to in-person visits is not only grossly inefficient in many cases, but it also limits data frequency and quality. And during a crisis like the COVID-19 pandemic, it’s simply infeasible.

By contrast, decentralized clinical trials look more compelling than ever. The Clinical Trials Transformation Initiative (CTTI) defines decentralized trials as those trials executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model. In layperson terms, the trial is conducted remotely with the participant remaining at home.

The industry has been looking to decentralize trials for years. Now, as health authorities worldwide struggle to contain the COVID-19 outbreak, there is a renewed push to rapidly implement remote healthcare delivery capabilities.

There are currently more than 55,000 interventional clinical trials actively enrolling and providing care for participants worldwide. In light of the current outbreak, it is critical that we continue to deliver high-quality healthcare to research participants, while also continuing to advance clinical drug development programs.

Decentralized trials are largely “geared” for exactly this type of situation. Of the 55,000 trials in flight, some are good candidates for a fully decentralized model — while many others can be managed in a hybrid model. Patients can be recruited and consented remotely. Physician “visits” can be conducted remotely via telemedicine. Data can be captured remotely (and frequently) via medical devices and mobile technology.

All of this expands our ability to conduct research by “untethering” it from physical sites — critical when people around the world are being told to “stay home” due to the COVID-19 pandemic. It reduces the risk of pathogen exposure to research participants, while potentially accelerating drug and vaccine development.

Shifting to decentralized or hybrid trials often requires changes to study design or regulatory approvals. While that’s no small task, it’s an urgent one for many clinical trial leaders right now. We need to take collective action as an industry — including regulators — if we want to ensure productive client trial progress and avoid significant loss of patient participation.

 

Let’s mobilize

With all of this in mind, there is an immediate opportunity for decentralized and hybrid trials to help us through these challenging times, using digital and mobile technologies to improve patient access, experience and outcomes. Let's work together as a community to drive forward faster, whether it’s streamlining trials for COVID-19 vaccines, reducing timelines for other therapies, or initiating new trials to address the 7,000 rare diseases that have no therapies on the market.

 

The COVID-19 outbreak has made it crystal clear: Decentralized trials are no longer a nice-to-have. Reducing trial timelines has to be a long-term industry imperative, and digital technology can help valuable research continue to move forward while keeping participants safe. Let’s start now, and let’s move faster together.

 

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If you want to join us in this effort, please contact Covid19@medable.com or reach out to anyone on the Medable team at www.medable.com. We’re working closely with regulators, pharma sponsors, biotech sponsors, clinical research organizations and other tech companies worldwide in an effort to mobilize and accelerate decentralized trial adoption. We welcome everyone’s participation and feedback, and we look forward to working with you.

 

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Alison Holland is the head of decentralized and remote trials at Medable. Ali has more than 30 years of clinical trial experience, most recently as Global VP & General Manager for General Medicine at Covance, a leading global clinical research organization. Ali has managed more than 300 clinical trials, working successfully with biotech organizations as well as global pharma on some of their most critical initiatives.

 

Topics: telemedicine decentralized trials remote trials