Why We Can’t Wait — Are Blacks Left Out of Clinical Drug Trials to Save Time and Money?

waiting roomNew drugs and biologics are tested to make sure that they work to treat a disease or condition and are more helpful than harmful.  Drug companies conduct drug trials in people in order to show the FDA that the drug’s benefits outweigh its risks, and it is important to know how the drug works in a range of people.  A draft guidance issued by the U.S. Food and Drug Administration (FDA) at the end of last year, while not considered to be a requirement for industry, does not support this approach.

The draft Guidance deals with “Enrichment Strategies” for clinical trials.  These “strategies” help drug companies save money and speed approval of their drugs by enrolling fewer subjects in clinical trials.  The assumption is that the type of people chosen for the clinical trial will increase the chance that the information collected during the clinical trial will show that a drug is effective.

Reducing the number of people included in a drug trial often negatively impacts enrollment of Black folks, who have not been enrolled in enough numbers in the past.  The Enrichment Strategies addressed in the Draft Guidance include decreasing heterogeneity (enrolling people that are the same), eliminating patients with co-morbidities (leaving people out who suffer from more than one disease), and ensuring “compliance” among participants (including eliminating people who might have trouble fully participating due to non-medical reasons such as “difficulty getting to the study site”).  All of these approaches are likely to negatively impact African Americans.

LWB’s comments to the FDA said:

“Although non-binding, this FDA Draft Guidance, when finalized, will represent the U.S. Food and Drug Administration’s (FDA) ‘current thinking on the topic.’   LWB is concerned that several approaches described by the FDA in its Draft Guidance (and acknowledged as widely practiced)  are likely to disadvantage African Americans who suffer from the diseases and conditions intended to be treated by the human drugs and biological products contemplated by this Draft Guidance.  In particular, LWB is concerned that the following enrichment strategies enumerated in the Draft Guidance may serve to disadvantage African Americans:  (1) Decreasing heterogeneity; (2) Reducing participation by patients with concomitant illnesses; and (3) Excluding patients ‘who are likely to drop out for non-medical reasons (e.g., because they have difficulty getting to the study site).’”

With the increasing diversity of this country, this is the wrong approach.  The LWB comments made the following major points:

1)    In order to make sure patients know how a drug is likely to work in the population likely to take a medicine, drug companies need to include people in clinical trials in a way that reflects the types of people expected to take the drug;

2)    Including people in clinical trials like those the drug will treat includes having people who suffer from more than one condition.  This is particularly important for African-Americans who tend to be sicker with more ailments; and

3)    Excluding patients who may have trouble reaching the study site is likely to negatively impact minorities and the poor.  Where there is a commitment to a diverse clinical trial, companies can help people get to the study site instead of keeping them out.  For example, companies could provide taxi vouchers, shuttle buses, or send nurses or other healthcare workers to the person’s home.  Another approach is to locate sites where they are accessible to people of limited means, or hire doctors to run the clinical trial that work in neighborhoods where people of limited means live.  These approaches already are used today by companies committed to including people in clinical trials in a way that reflects the type of people expected to take the drugs.

If clinical trials are not diverse, and we are excluded, eventually information may be collected and available on how effective or harmful the drug may be for us.  Maybe there will be no difference when compared to the drugs effects on the narrow group in which the drug is tested.  If there is a difference it may come out eventually, but not until the drug or biologic product is approved, hits the market, and is prescribed broadly.   Only then, information may be collected on the drugs effectiveness and side effects in a diverse population, including African Americans.   We should not have to wait that long….

You can view the comments LWB filed with the FDA here: Living Well Black FDA Clin Trial Enrichment Comments.

You can see the FDA’s draft Guidance here.

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