There are not enough minorities, seniors and children included in trials of drugs for minorities, seniors and children. That’s simply bad for society and industry.

That’s one of the main thrusts of the Eliminating Disparities in Clinical Trials (EDICT) report, released recently by researchers at Baylor College of Medicine in conjunction with the Intercultural Cancer Council.

Better For Everyone

Take pediatric psychiatry. If more children had been included in trials for anti-depressants, drug makers may have known about the suicide risk, and could have avoided the massive (and expensive) fallout a few years ago. If drug makers knew more about how their drugs affected seniors with common co-morbidities—conditions that often get seniors excluded from trials, but are present in seniors in the real world—those compounds could be better tailored to and marketed to those seniors. If there’s a better understanding of how certain drugs affect minority groups, which we now know may have genetic differences, those too can be properly targeted to those groups.

The upshot? Better sales. And better safety. The aim of the report: to get industry and government to take notice of the knowledge gaps in various demographic populations, and to work to close them.

“Scientifically, it doesn’t make any sense to create biologics that are to be used in populations that look nothing like the population they are being tested on,” says Dan Goldberg, policy fellow at Baylor who worked on the report, which includes a nine-step action plan.

Fix This

According to the EDICT report, some of the areas that need correction are:

• Strict exclusion criteria that exclude patients who don’t speak English and/or patients with co-morbidities.

• Lengthy and complex consent forms that are available only in English.

• Vague information about how Medicare, Medicaid and private insurers may reimburse for costs associated with taking part in a trial.

• Insufficient training for institutional review boards (IRBs), which, say the authors, results in approval of protocols that leave out underrepresented populations.

Money, Though?

But what of cost? Won’t such efforts cut too deeply into the profits of industry, which funds 75 percent of all clinical trials? Study author Armin Weinberg, director of Baylor’s Chronic Disease Prevention and Control Research Center, says nope.

“I think we’re getting a sense that if we don’t do this, it could be an even more expensive proposition for drug manufacturers,” he asserts.

Take the ADA

Goldberg adds that if efforts to fold in these groups are included in the initial design of the study, rather than tacked on later, it doesn’t have to add to the cost. Not much, anyway.

“Take the Americans with Disabilities Act,” he says. “Initially, everyone thought the costs [of making buildings accessible to the handicapped] would be exorbitant. But if you incorporate the Americans with Disabilities Act’s (ADA’s) requirements into the design of a building, it turns out to be cost-efficient. It’s in retrofitting a building after the fact that it gets extremely expensive, if not downright impossible.”

To put their money where their mouths are, researchers at Baylor are currently incorporating their suggestions into asthma and cancer trials, so far with good results. For example, says Weinberg, the Baylor researcher in charge of those efforts now routinely asks sponsors for extra funds for the translation of consent forms into languages other than English. “He’s never been turned down,” says Weinberg.

Mostly White

Eighty-eight percent of the people who participate in trials are Caucasian. Why are other ethnic groups largely not a part of the process? It’s multifactorial, says Weinberg.

“There’s lots of fear of clinical research from some members of some cultures,” he says. “Some people can’t take time off from work. There are questions about insurance coverage—people without coverage can’t participate. Sometimes, it’s a co-morbidity issue. In certain cultures—among African Americans and Hispanics, for example—there’s a lot of obesity, and that can get them excluded from a trial.”

Speedy Process

Couple these conundrums and impediments with industry generally being in a hurry.

“Sponsors are trying to complete the study as quickly as possible,” Weinberg adds. “And unfortunately, there hasn’t always been a system of checks and balances on what the study proposed versus what is actually done.”

Allocation Conundrum

Another problem with clinical research today? Far too much duplication, says Weinberg.

“We know what drives allocation in the public sector: advocacy groups that are organized and well-funded,” he says. “The obvious example is breast cancer. On the other hand, in the private sector, what drives research is mostly profit. That leaves us with certain diseases with very high fatality, but low incidence so they get no funding. Like pancreatic cancer.”

So far, though, there’s no good data on the extent of the duplication, or the diseases for which research suffers. The EDICT report calls upon the Institute of Medicine to do such a study.

Thoughtful Consideration

Says Weinberg, “There’s clearly not a resource allocation process that looks at the distribution of research funds. Given where we are in our economic situation right now, there would be a benefit to looking at how industry, government and nonprofits might thoughtfully consider where those dollars might be allocated, so we don’t have everybody putting their dollars into one disease.”

In addition, the EDICT authors call on the FDA to harmonize its policies with the NIH Revitalization Act of 1993, so that trials are required to include under-represented populations. The report also calls on government and industry to work together in designing new trials, suggesting that government consider financial incentives for including more women, elderly, minorities and rural populations. The report also suggests that government impose penalties on sponsors who don’t do so.

Discriminating Journals?

The EDICT authors want peer-reviewed journals involved, too, suggesting that they refuse to accept manuscripts about trials that don’t discuss how the study subjects’ demographics correspond to the population that bears the greatest disease burden.

The EDICT report took four years to put together, and was funded by an unrestricted educational grant from the biotech firm Genentech.

Weighing Costs

The time is now, says Weinberg, if not to run out and act, then at least to discuss what lies ahead.

“We need to have a discussion now, and recognize that we have an opportunity now to implement new techniques and new designs,” he says. “We ought to think through how to do it right. And we ought to also weigh the cost of doing that with the cost of not doing that.”

—by . Here are her previous articles about recommendations for including more children and elderly in clinical trials.