An August 13 Forbes.com article by Henry I. Miller and S. Stanley Young asked whether designing better clinical trials would be helpful in lowering development costs and yielding more new pharmaceuticals.
An August 13 Forbes.com article by Henry I. Miller and S. Stanley Young asked whether designing better clinical trials would be helpful in lowering development costs and yielding more new pharmaceuticals. The authors urged designers of clinical trials to think outside the box to reduce the various diversity gaps in trial participants and moderate the costs of these studies.
If we accept the premise that it is possible to design a better clinical trial, then it must also be possible to improve clinical trial recruitment. Perhaps a little thinking outside the box will go a long way here, too. Miller and Young build from their theory that the development of a new medicine is generally focused on its ultimate marketing to a broad range of people, so why not start by recruiting from a broad range of people as well?
Citing differences in the ways men and women, as well as different ethnic and age groups, respond to certain medications, the authors state that it is difficult to manage statistically significant quantities of every possible population. They look at ideas like an “adaptive design clinical study” or “large, simple, randomized trials” as possible solutions. For trials which do require large numbers of participants, they suggest reducing costs through self-reporting of data over the Internet instead of during expensive in-person visits.
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No matter what ways are developed to improve the design of clinical trials, they all still require effective recruitment strategies. Some “out of the box” thoughts here might include:
- Move beyond the current investigators’ practices: Relying on existing patient volume could be slowing your recruitment efforts when there are far more proactive approaches available. Digital marketing can add an effective recruiting component without significantly increasing costs.
- Increase the speed of patient enrollment: More patients are searching online for medical information. Search engine optimization strategies build on this interest to increase awareness of trial availability directly to a targeted group that is most likely to be able to participate. Increasing the speed of patient acquisition reduces the time needed for a trial to reach “Fully Enrolled” status, and allows the trial to begin faster.
- Cast a wider net: Although Google Adwords and SEO strategies for Google, Yahoo, and MSN are effective, it is also necessary to go beyond search engines to contextual networks, display networks, or health and wellness networks to attract potential participants. Outbound communication efforts through social advertising, e-mail, and directories can significantly expand the potential reach.
- Online screening: Instead of investing in live investigator screenings, create a conversion-optimized website that allows prospects to self-qualify. This saves time for everyone, and allows investigators to focus on treatment and data collection.
Any strategy must remain in compliance with all regulatory requirements, but the benefits of thinking outside the box can far outweigh those efforts by speeding enrollment and cutting costs. Improved clinical trial recruitment is the key to success for today’s improved clinical trial designs.
