Patients in Research: What the Professionals Don’t Get

Guest Post by Rebecca Dresser

When scientists and doctors get together to talk about accelerating medical advances, someone inevitably brings up the need for more research subjects.  Not enough patients are participating in clinical trials, experts complain.  If more patients were part of medical studies, we could make more progress in treating disease and improving human lives.

Why do relatively few patients join studies?  The National Academy of Sciences and similar groups blame the problem on regulatory impediments and an inadequate supply of physician-researchers willing to ask patients to enroll in trials.  They want more funding to support physicians’ research efforts, and they want review committees like IRBs to streamline their work.

But these measures won’t be enough to fix the problem.  To really understand why patients don’t enroll in trials, and why many who do enroll drop out early, you have to ask them. I know, because I was one of the patients who turned down a trial.

Eleven years ago I was diagnosed with advanced cancer.  Although there were ways to treat it, my odds of survival were less than fifty percent.  The medical center’s tumor board, a team of cancer experts, evaluated my case and recommended a combined regimen of four chemotherapy drugs and radiation.  The FDA had just approved one of the drugs for my kind of cancer.

I met with an oncologist who explained the recommendation to me.  Then he offered another option: I could sign up for a clinical trial comparing three different treatment regimens for the type of cancer I had.  Because I knew that trials like this could lead to better treatments in the future, I was willing to consider participating.

But as the doctor described the trial, I began to lose interest.  No one in the trial would receive the newly approved drug, and none of the trial regimens were as intensive as the one I could get outside the trial.  I also learned that joining the trial would probably lead to a delay in my treatment, for I would have to be randomized to a specific group and wait for other administrative tasks to be completed.

My tumor was already large and painful, and eating had become very difficult.  I couldn’t stand to wait any longer than necessary to start treatment.  And I wanted to survive.  I felt safer with the treatment plan that cancer experts thought would be best for me.  So I chose the regimen the tumor board had recommended.

Professional groups like the National Academy rarely hear from people like me when they consider the shortage of research subjects.  They also don’t pay enough attention to empirical data describing patients’ reasons for declining participation and for dropping out before studies are completed.  As a result, these groups don’t effectively address subjects’ struggles and disappointments in studies.

If experts did listen to patients, here are some of the things they would hear. First and foremost, patients want medical care.  Many welcome the chance to help others through study participation, but few will knowingly compromise their own health needs for altruistic reasons.  Moreover, a diagnosis of serious illness alters one’s psychological state.  Seriously ill patients are looking for support and guidance from their doctors.  Impersonal research requirements like randomization and control groups can be hard to reconcile with the sensitive and individualized care patients expect.  And few patients welcome the prospect of undergoing extra procedures and examinations for the sake of research data collection.  Even an additional one or two visits to the clinic can impose an immense burden on patients already burdened by serious illness.

Experts trying to increase trial enrollment won’t succeed unless they confront matters like these.  To do so, they must consult patients who know what it is like to be asked to enroll in a study.  They must listen to subjects’ comments, both positive and negative, about the studies in which they participated.  They must work with experienced patient-subjects to develop accurate and compassionate ways to convey information about trial methods and demands.  And they must make every effort to reduce the burdens that trial participation imposes on patients.

Research subjects are volunteers, after all.  They don’t have to say yes to trials.  Although some researchers and ethicists argue that patients should be required to participate in research, that argument has attracted little policy support.  And I doubt that many patients would favor such a requirement—I certainly wouldn’t.  For the time being, people remain free to make their own choices about research participation.  To develop better recruitment strategies, experts must learn more about how patients perceive and evaluate their research options.

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