• Kate

Medtech Vision Panel Recap: The Future of Clinical Trials

Last Friday I had the opportunity to see a months-long volunteer project fulfilled. Assembled on the MedtechVision 2022 stage were five brilliant and accomplished experts on a stage talking about that mainstay of the life sciences industry: the clinical trial.

Moderated by Rock Health's COO, Megan Zweig, the panelists included Jaime Wheeler (Senior Vice President, Global Clinical Affairs, Edwards Lifesciences), Kendal Whitlock (Head of Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance), Joyce Nortey (Sr. Director, Clinical Operations, Evidation Health) and Yarmela Pavlovic (VP Global Regulatory Strategy & Policy, Medtronic).

Like most conversations around a rapidly evolving field, the panel discussion started with trying to find consensus around what to call the topic at hand. Many life science groups are using "remote" and "virtual" interchangeable in describing the use of telemedicine technology in completing trials. For others (the FDA included) "virtual" refers only to artificial study simulations. De-centralized trials could mean accessing patients across an entire country via telemedicine, or it could mean that the study is completed fully in person, just at several different clinical sites. While the existing industry infrastructure, the emerging tech solutions and the regulatory bodies continue to discuss nomenclature, there is one thing that can be agreed on. The original tech hype gained a serious reality check in the pressure testing of the Covid-19 pandemic.

In the first half of 2020, as all non-emergency clinic activities were cancelled and trial subjects isolated in their homes, clinical trial managers turned to the tech solutions that had been repeatedly pushed across their desks for the last decade. The pain of continuing with the status quo had finally overwhelmed the risks and inefficiencies of change. The result was, depending on the product you were working on and the patient demographics, mixed.

Ambitious pitch decks aside, not all clinical trials became 100% remote overnight with their first taste of digitalization. Trials run at a single geographic location did not become globally accessible using an app. The "all or nothing" idea that a single approach or technology would rapidly champion across all indications, drug or device, young or old, was rapidly debunked. As Jaime pointed out "We're [Edwards] primarily implants, we are not doing that remotely".

Still, there was change. The shift in technology adoption, the increased flexibility in geography, was not binary. Trials are now falling along spectrums of tech adoption and location, becoming hybrids matched to whatever is most effective for a particular disease or demographic. Heart Valves may not be installed remotely, but remote technology can track and monitor the success of that implant far longer than ever before possible.

Among the other hype elements that fall apart under real world testing was that of cost savings. Besides the sunk cost of implementing organizational change in anything as complex as a clinical trial operation, there are costs from sending care providers to patient homes, costs for technology licensing and training, even costs to cover legal fees and insurance due to changing risk elements. Money may be saved in certain aspects of the implementation, but (as Yarmela described it) "ultimately it is more a case of cost-shifting than cost-saving".

Panelists also addressed the often-stated promise of improved diversity. In person visits to a limited number of clinical sites meant limiting the pool of test subjects to those that lived near certain clinical centers. Kendal shared how 95% of the (US) population has never taken part in a clinical trial. Moving to tech enabled remote options could reduce the barriers of time and distance but may worsen the social and economic hurdles. Smart phones have clearly played a valuable role in helping communities leapfrog infrastructure challenges. Joyce brought up the thought-inducing statistics that (globally) there are more smart phones on earth than toothbrushes and toilets combined. Smart phones without high volume data access, however, fall short of the video conferencing and large file sharing capability necessary for remote care. Studies of rural or disadvantaged communities that were forced to pivot to telehealth during the pandemic were sobering in revealing the technology’s potential to worsen existing inequalities of care.

The interest of major consumer tech companies in clinical trials (such as Apple and Google) has inspired hope that the patient journey may someday approach the level of service and satisfaction of consumer products. While health app usability design could definitely use the upgrade, a more fundamental shift in how pharma and device companies relate to the human beings that populate trials is still a work in progress. Clinical trials designers have always had to balance the burden of the trial to the patient against prompt recruitment and trial completion. Too many tests, too many trips to the clinic, too many side-affects and the trial is put at risk as patients drop out. As tech allows us to recruit more widely, and eventually clinical trial participation becomes a regular part of regular clinical practice, we will have to move beyond the purely financial models and address the ethical ramifications of clinical trial patient interactions.

Currently, most clinical trial participants learn about trials at one of the most terrifying, confusing points in their lives: right after a devastating diagnosis. They are scared, distracted, and not ready for reading through the educational material thrust at them. As stressful as that prognosis is, there is the highly common occurrence of receiving a devastating diagnosis, applying to be part of the trial, and being excluded for any dozens of potential reasons (check out the Bio Eats World podcast on the ‘Trials of Clinical Trials’). These patients pass through a company's files only briefly, but leave them far worse for having done so. For those that do continue in a trial, the trial designs may have been tweaked to meet enrollment quota, but trial completion can still come at the cost of heavy reliance on family and caregivers. This strains families and damages patient confidence and autonomy. Sending clinical personnel to a patient's home may appear "easier" in terms of access, but crosses new boundaries of personal space, forcing patients to concede their privacy or dignity for the sake of that access.

There is no quick and easy answer to reconciling the opportunities tech and new study models offer with the larger ethical questions they bring. One thing the whole panel could agree on was the need for new types of patient education that would allow them to better navigate these challenges for themselves. Not just pamphlets handed to terrified individuals, or "gaslighting" patients into compliance, but the kind of education that will allow trust to be built between patients, doctors and companies.

Modern healthcare (and the clinical trials that run within it) will ultimately rely on patients literate in digital health. Current and earlier generations have grown up with general health education, learning about toothbrushing, nutrition and exercise. Today's children are undergoing training in "digital literacy" to prepare them as the future workforce. With many electronic medical record portals transferring access to patients starting at age 12, training in managing one’s health data should be every bit as critical as learning email. For the future of clinical trials, this will ultimately mean trial candidates acquainted with data sharing, informed consent and alternate care options years before they walk in (or log in) to a clinical site.

The clinical trial space is highly fluid and currently filled with speculation from major players. With 9000 stores across the country, 78% of US citizens are within 5 miles of a Walgreens. As Kendal pointed out, that is a major network of potential trial access sites sitting under a familiar brand. Digital Therapeutics are pivoting to remote clinical trial platforms. Apple and Google continue to strive towards legitimacy as serious health tech players. Changing up where and when patients access their health resources naturally brings opportunities in how those health resources are developed and evaluated.

This broad interest, while anxiety inducing to financial forecasters trying to find the eventual "winner", is a source of hope to the clinical trial experts looking at the future of their field. The more players in the space, the more brains, the more approaches that are tried, the more patients will win.

Many thanks to the panelists for sharing their experiences and thoughts, and for Medtech Women for giving them a stage and an amazing audience of doers and thinkers to learn from it.

PS...For those who find it hard to believe the world has more smart phones than toilets, check out https://www.worldtoilet.org/ for the reality of sanitation in many parts of the world and what you can do about it.

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