From The Editor | March 17, 2015

"Virtual" Recruitment Roundtable: Disruptive Innovation In Clinical Trials

By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

Anna Rose Welch

In the final installment of this "virtual" recruitment roundtable series, Clinical Leader’s recruitment experts home in on some of the most disruptive recruitment solutions in the industry today, as well as highlight some of the ways pharma could continue to innovate in order to streamline recruitment in the future.

AR Welch: What is/are the most disruptive recruitment strategy(ies) in the industry today? Is there anything else pharma can be exploring to step “outside of the box” with engagement?

Systems that allow patients to participate in multi-study screening will evolve. Whether applied to sponsor-specific programs or cross-sponsor product class development, sponsors will need to articulate how they are weighing the economic value of a recruited patient to benefit all stakeholders. Small, clinical-stage sponsors may place a higher value on each patient. When that company’s major asset (an investigational product) achieves regulatory approval, its valuation is probably more positively impacted than a larger sponsor. Another innovation pharma could explore would be creating trial models that make patient participation easier, such as screening and at-home visits, in order to reduce patient and caregiver burden and boost recruitment. Gamification strategies could be instrumental as targeted patients continue turning more to digital technology. When these patients respond to a call-to-action, healthcare and monetary incentives that stoke gaming curiosity and create altruistic, viral behaviors could be implemented. — Kurt Mussina, VP and general manager, Frenova Renal Research

Crowdsourcing of protocols is certainly one disruptive new approach. The use of pharmacy chains like Walgreens and CVS as study sites for trials requiring only minimal visits and/or procedures is certainly growing. Adaptive trials continue to grow and evolve. Ultimately, there are much more efficient approaches which can be taken to the testing of new investigational treatments, but those approaches typically involve more risk. Societal viewpoints regarding drug research are largely risk adverse, as are the views and practices of the FDA. Until we see that change, I’m afraid the industry will continue to crawl along. — Dan McDonald, director, business development, DAC Patient Recruitment Services

This is a dangerous concept because it often leads to an unrealistic expectation that sponsors haven’t yet uncovered that long awaited panacea. The idea of disruptive innovation is clearly important within the overall clinical development process, but within patient recruitment it too often becomes a way to avoid some of the underlying issues that are causing problems in the first place (e.g., unrealistic protocols, lack of trial awareness, ineffective site relationships, etc.). In recruitment, some of the most effective innovation is incremental, not disruptive. Disruptive innovation is either unproven or too aspirational. Patient recruitment and underlying tactics have improved year over year, and there are still incremental gains to be had at the individual tactic level and the overall tactical mix that will have a profound effect on the recruitment industry. We should focus on those incremental improvements rather than looking for the silver bullet, with the understanding that maintaining a forward-thinking perspective in parallel is always appropriate.Roger Smith, SVP, global clinical operations, Acurian

Targeted marketing, social media, and data mining have evolved as patient recruitment strategies. All of these tactics have a place in recruiting patients for clinical studies, as does outreach to support groups, patient advocacy groups, social forums, and blogs to reach specific patient populations. Until now, we have recruited the investigators and relied on them to find suitable patients. However, a broad central database would allow a more rapid matching of qualified patients with appropriate sites and studies. — Marc Hoffman, MD, CMO, Theorem

Tune into the previous six segments of this roundtable series!