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Ethics forum explores critical role of clinical trials in medical research

By Chris Palmer

UCSD clinical professor Georgia Robins Sadler discussed the many roadblocks in the recruitment of subjects for clinical trials with an audience at the Reuben H. Fleet Science Center Wednesday night as part of an ongoing series of forums about medical research ethics.

Central to her talk, titled ‘What the Public Needs to Know about Clinical Trials,’

Sadler, the Associate Director for Community Outreach at the Moores UCSD Cancer Center and a clinical professor in the UCSD Department of Surgery, pointed to the time and effort it takes to recruit volunteers for clinical trials as one of the largest barriers to conducting medical research in the country today.

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According to mandates from the National Institutes of Health, research into new drugs and medical treatments involving human subjects must be conducted with samples that are representative of the nation’s population sub-groups.

“Unless samples include participants of diverse racial, ethnic, age, and other characteristics, conclusions from studies cannot be generalized with confidence to the population at-large,” said Sadler. “Most people would be wary of accepting medical recommendations drawn from research in which no one from their community was involved.”

However, recruiting adequate numbers of subjects can be a challenge. “Many studies that have adequate funding get cancelled because there are not enough volunteers,” said Sadler.

As a result, most clinical trial coordinators allocate a considerable amount of resources towards subject recruitment, yet for the average person who actively seeks out a trial to enroll in, “It can be like finding a needle in a haystack,” according to Sadler.

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“These studies come and go all the time, and there is no central repository of all the trials going on at one time in the U.S. Unfortunately, it takes some serious Internet skills to find the appropriate studies.”

“What we need are clinical trials navigators,” said Sadler, calling for the appointment of clinical trial experts at the local, state and federal level to help connect patients wishing to enroll in clinical trials with the trial coordinators who are desperately looking for them.

Sadler discussed additional barriers to enrolling subjects in clinical trials, including overly complex informed consent forms and misconceptions about placebos. Sadler said that many people are concerned that, upon enrolling in a study, they may be assigned to the control group and given sugar pills, when in fact the control group is given the current standard of care.

Sadler recommended several other ways in which subject recruitment can be improved:

• Clinical trial coordinators can make recruitment a larger part of their study’s budget

• Community doctors can be given increased compensation for referring a patient to a clinical trial. “Doctors essentially lose that patient to the clinical trial, and we need to find some way to compensate them so that they will be motivated to make referrals.”

• Social media can be used to locate potential study volunteers. “Right now the person who is likely to get cancer, someone in their 60s, 70s, or 80s, is likely to be tech-challenged, but we can get to them through their kids and grandkids.”

Wednesday’s event was the fourth in a series of nine “Exploring Ethics” forums hosted by The Center for Ethics in Science and Technology, in partnership with San Diego’s “The Henrietta Lacks Project,” devoted to discussions of medical research ethics and diversity issues related to “The Immortal Life of Henrietta Lacks,” last year’s award-winning book by science writer Rebecca Skloot.

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In her hour-long Q & A with the audience, Sadler addressed one of the primary ethical considerations of Skloot’s book, the lack of proper informed consent that led to Henrietta Lacks’ cells being used without her permission in the early 1950s. Sadler said that studies currently taking place in the U.S. have very strict rules in place to protect patients’ rights. “It is very different doing science today then even 20-30 years ago.”

The remaining five “Exploring Ethics” forums will also take place on the first Wednesday of each month through May 2012 at the Reuben H. Fleet Science Center in Balboa Park. Professors of biology, anthropology, medicine, religion, law and ethics from several San Diego area colleges and universities will moderate the forums. A grant from the Gerald and Inez Parker Foundation was recently awarded to the Center for Ethics to fund broadcasts and webcasts of the forums over UCSD-TV.

More information at: https://www.ethicscenter.net/exploring-ethics-forums.