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Tackling A Clinical Research Challenge Head-On at the 2019 Bridging Clinical Research & Clinical Health Care Conference

by Dan McDonald

For the second year in a row, clinical research executives gathered in the nation’s capital to discuss one of the biggest challenges tormenting the industry – how to improve the number of patients and physicians participating in clinical research. It’s an age old problem and one that won’t go away soon. Less than 5 percent of the eligible patient population in the U.S. participate in clinical trials annually. The Bridging Clinical Research & Clinical Health Care Conference, known as “Bridging,” puts the number at 3 percent. The same is true for physicians who are registered as clinical investigators — too many trials and not enough physicians wanting to get involved. The time and cost impact of this issue is well known. What isn’t well known is the solution.

“Bridging” aims to bring together bright minds from sponsors, CROs, and vendors to tackle the issue. I was invited to chair a roundtable discussion at the event, which allowed a deep dive into the issue with some really smart and interesting individuals. Specifically, my table examined the gulf between industry hype around the use of technology (and other cutting edge approaches to addressing the issue) and the realities of what industry is really doing on a day-to-day basis in 2019. I was joined at the table by an entrepreneur who had recently launched a new service to deliver information about clinical trials directly into the waiting rooms and point-of-care tablets of clinicians. Another executive was a former patient recruiter who was now helping to implement home health care solutions in the clinical space – a growing and hot segment of the market. Another executive represented one of the leading companies in the burgeoning space of leveraging genetic profiling to match people up with various health pathways, including clinical trials. The table was rounded out with a physician and a pharmacist, both on the front lines of health care.

The group agreed that there are many exciting new solutions being brought forward by innovative companies to bring clinical trials to the masses:

  • Big Data
  • Artificial Intelligence
  • Virtual Trials
  • Wearables
  • eConsent
  • At-Home Study Visits
  • Transportation Assistance

I’m sure I’m missing a few. Some of those are more technology driven, and some are more grass roots and labor intensive. In total, they may represent the new frontier of clinical trials, perhaps helping make the process of testing investigative therapies in humans, something that is known and understood in homes globally. For now, there was agreement that industry hype – from articles in trade journals, to conferences and on social media – is more talked about than adopted. In fact, technology has always been far ahead of implementation when it comes to the conduct of clinical trials. Each individual had theories about why this was the case, but in general, the group pointed to the highly regulated and risk-averse nature of the industry – and the operating culture at many large biopharmaceutical companies. Taking the risk of implementing new cutting edge solutions was often seen as just too risky by the individuals running the trials. Getting the right senior executives, capable of implementing the change, was too challenging to reach and too slow to roll out if reached and convinced.

There was real concern by group members that consumer-facing technology companies could eventually bypass biopharmaceutical companies in the way that new therapies are developed. Consumers are growing increasingly accustomed to receiving information, insights, products, and services instantly. From the point of view of leading technology companies, drug development could represent a large and attractive market. And consumers may demand they go there.

In the second stage of the roundtable discussion, I presented the results of a survey of clinical operations personnel that Imperial conducted. The survey aimed to understand the attitudes and behaviors of front line clinical operations personnel at biopharmaceutical companies as it relates to the function of patient recruitment. You can find other articles about this survey on the Imperial blog, located here. The survey findings we discussed most were those that focused on what sponsors are actually doing today to recruit patients. These findings brought to light the gap between the hype and talk about leading edge approaches versus the reality of the much more traditional approaches actually being deployed.

Recruitment Tactics Used Most Often:

  • Recruitment Kits (39%)
  • Physician Referral Programs (30.5%)
  • Outreach to Advocacy Groups (10.5%)
  • Web-Based Marketing (9.5%)
  • Broadcast Advertising (5.7%)
  • Other (4.8%)

Nearly half of all sponsors aren’t tracking the key performance indicators for these recruitment tactics.

The survey also gives insight about the future and where sponsors saw the industry going in the next 3-5 years. Perhaps like flying cars, everyone thinks that the broad-based implementation of state of the art approaches is imminent. The roundtable group was somewhat skeptical as to how close the industry is to that, but everyone was certainly bullish about the need.

 The future:

60% Smartphone Apps, Wearables and Other Smart Tech

50% Adaptive Trials

45% In-Home Study Visits

37% Non-Site Trials (Pharmacy, Walk-In Clinics, Health Clinics)

30% Virtual Trials

 As one roundtable participant clearly stated, “There are many variables that impact whether a particular approach should be used for a particular study and whether or not it will work.” He went on to say that “Some of these technologies are currently being used, but the value proposition is often limited to a specific type of study, patient population, geography or all of the above.” He really nailed it. Even with the advancement of technology and the slow and steady uptick in adoption we hope to see in clinical research, there will likely not be one approach that fits all studies. Understanding what approach to implement and when will be critical. “Bridging” is the right conference at the right time in that regard. I hope that attendance will grow and that those most able to impact change at sponsor companies will participate in the discussion. In the meantime, the hype goes on.

  •  Do you agree that the gulf between talk and adoption is large?
  • Why do you think that is?
  • What is the risk of slow movement into these technologies?
  • What has been your experience with these technologies?
  • Do you think our largest sponsors empower their clinical ops teams to take risks and drive change? What’s the incentive?

I look forward to your comments and perspective, which you can enter below.

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