Baiting the hook: How pharma might lure physicians to clinical trials
Most everyone sees the value in getting effective new therapies to market, but the medical community’s inability to find the right trial participants at the right times remains a huge — and very expensive — deterrent.
A Covance study recently estimated average site start-up costs at $50,000, pointing to a nearly $2 billion loss by non-performing sites between 2006 and 2010. Some 60 percent of oncology trials during that time failed to enroll even one patient. A different study found only 3 percent of cancer patients ever participate in such trials.
So where’s the disconnect? While many potential subjects have valid reasons for choosing not to participate, others simply don’t know about studies that may pertain to them. In many cases, that’s because their doctors are unwilling or unable to either funnel patients into the trial pipeline or to become principal investigators or clinical research physicians in such studies.
A 2014 global Drugdev.com study pointed to a rising number of clinical trials, with some 5,408 medicines in development. But physician participation was falling in both Western Europe and the U.S. Those who did participate said they were primarily motivated first by the ability to be at the forefront of research, and second by the opportunity to benefit current patients and future patients.
Their top reasons for not participating? Lack of time, lack of resources, complicated logistics and a lack of information on how to start. That’s in line with research by Sayeeda Rahman, et al, which also points to other factors including “trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians and sometimes a scientifically uninteresting research question.”
It’s true trial protocols have become more complex as patient populations specialize and extend into Third World countries. And some claim trials are only truly profitable for physicians if they can hire their own assistants and run 98 percent of the testing themselves.
The pharma community is doing its best to address such issues, removing barriers when possible and emphasizing the altruistic benefits of furthering new therapies.
One successful solution has been drugdev.com, a website founded in 2009 to pair sponsors with physicians interested in serving as PIs. The list of PIs has since grown to 80,000, says CEO Ibs Mahmood, some 20 to 30 percent of which regularly conduct trials. He says the importance of that diverse group to the future of clinical trials was previously underemphasized.
“We think of investigators as the foundation stones on which clinical trials are run … (but) it’s astonishing how poorly the industry seems to look after them, at least on a global long-term basis,” he notes. “In any other industry, if that lynchpin was known, everybody would bend over backward to make sure they knew who they were and what they needed.”
Some other ways the industry may better recruit research physicians as PIs or supporters include:
- Provide more training about the fundamentals of research design and methodology during their undergraduate and postgraduate education.
- Target inexperienced PIs to handle less complex studies. “Sponsors can also help the research industry by creating less intimidating studies (such as phase 4 studies) and approaching physicians who expressed interest in doing clinical research but have never before participated, in order to get their feet wet,” notes Dan Sfera, CEO of Global Clinical Trials LLC.
- Establish and market “preferred site model” research clinics through which managing CROs work toward longer-term, more productive relationships with referring physicians.
- Focus on platforms like TransCelerate Biopharma Inc., which helps organize clinical trial processes (and data) from start to finish.
- Encourage sales reps and other pharma staffers to be more proactive about informing doctors about upcoming medications.
- Promote the concept that physicians may conduct clinical research directly from their private practices, generating new revenue streams and insights on new therapies.
- Provide more accurate reporting via the Sunshine Act. Sfera argues it now dictates the PI be listed as receiving all gross funds paid to a trial site, making him appear to over-profit.
- Offer better financial incentives, though concern exists about related bias.
For the system to work, it’s increasingly important that pharma takes a big part in getting physician support.
“Physicians who participate in a clinical trial for a medication are more likely to prescribe that medication,” notes Sfera. “It’s a win-win situation for everyone as long as the pharmaceutical industry is able to capitalize on the opportunity.”