The economic crisis and enrollment in clinical trials

The economic downturn has clearly had an impact upon many people’s lives. Now it’s affecting participation in drug trials (and in more than one way), according to the Austin Business Journal.

Here is the story: More applicants for fewer drug trials.

Like other contract research organizations, or CROs, FutureSearch says the bad economy has brought a bit of a mixed bag for business. One one hand, recruiting for clinical trials may be getting easier with more people, some out of work, expressing an interest in trials — some of which offer thousands of dollars to participants. On the other, major pharmaceutical and biotechnology companies are said to be funding fewer clinical trials.

“We have had a rise in interest from people that actually have clinical depression and generalized anxiety,” Garcia said. But while “we might see an increased need from people, … I think in actuality things might be slower on the pharmaceutical side, just due to the economy.”

There are two important points to emphasize from this article and they both have to with the reasons why people may enroll themselves into clinical trials. Researchers need to be attentive to the kinds of reasons that might compel participants to take part in their trial — and appropriately gauge things like incentives, compensation, and how benefit and risk are described.

From the article, it’s clear that the profile of the typical research participant is changing, as more and more people face financial challenges and find themselves out of work. Earning fifty dollars for a few hours as a participant may be someone’s only option at a point in time to earn money. Even without the context of the current economic crisis, there have always been people who have enrolled in trials to pay bills and buy food. So while this isn’t a new issue, per se, I think that it’s well worth emphasizing the importance of evaluating compensation amounts relative to participant burden, and ensuring two things: That potential participants understand their potential for harm, and that they have no known contraindication to taking part in a drug or intervention trial. Someone desperate to get the fifty dollars certainly may be willing to take a greater risk that they would under better circumstances, or enroll in a study that they might not otherwise be interested in were it not for the compensation, which in essence becomes coercive in these kinds of situations.

It’s clear from the literature that even well-educated and aware participants have skewed notions about enrolling in clinical studies. Many people think that they will necessarily be guaranteed some kind of benefit. It’s been demonstrated that patients who are approached by their physicians to enroll in clinical trials mistakenly believe that their doctor wouldn’t put them in a trial that would expose them to potential harm. Enrolling eligible patients into clinical trials means that they may well recieve a substandard treatment, an ineffective treatment or even a placebo. It’s up to researchers to ensure, during the informed consent process, that participants clearly understand this. And that they clearly understand that once they enter the trial they are no longer patients (solely in the context of their involvement in the trial), but are participants. In other words, it adds a relationship,one that is markedly different and may conflict with, but not negate the already standing relationship between physician and patient.

What this demonstrates is a pervasive misunderstanding of the difference between research and therapy, participant and patient. Research and therapy have different goals and outcomes, limits and constraints. It’s particularly worrying that the article notes that more people with serious problems like depression and anxiety disorders are seeking enrollment in relevant trials based, as the journalist notes, on need. Need for a particular therapy, treatment or medication — that can’t be accessed in other ways due to financial constraints — can’t and shouldn’t be an acceptable reason to allow someone to enroll in a trial. This is a particularly difficult issue when considered within the context of the US health care system and the financial limitations to accessing health care and treatment, but it’s not much better when considered within a Canadian context, in which coverage for things like medication and psychotherapy are usually tied to employer-provided benefits, instead of covered under the Canada Health Act. Everyone involved in clinical research must consider that people in need, both financially and, as noted in the above story, psychologically, may be particularly vulnerable to coercion or far more willing to be exposed to greater risk.

~ by Nancy Walton on April 1, 2009.

2 Responses to “The economic crisis and enrollment in clinical trials”

  1. Thank you very much for this fantastic post “The economic crisis and enrollment in clinical trials”. This post is very informative.

  2. Great post….

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