‘I’m In’ Campaign and FDA Recommendations Look to Boost Diversity in Clinical Testing

Hispanics are most disproportionately affected by asthma, cancer, and heart disease, and scientists are asking why.

What is clear is that few Hispanics participate in the clinical trials that test drugs to treat these diseases and others. Overall, just 1 percent of clinical trial volunteers are Hispanic. And the underrepresentation is true across all ethnic and racial minorities.

A new effort is underway to increase clinical trial participation among traditionally underrepresented populations in order to help researchers find better ways to fight diseases that disproportionately impact certain populations.

The “I’m In” campaign began as a collaboration between the Pharmaceutical Research and Manufacturers of America, an industry advocacy group,​ and the National Minority Quality Forum, a nonprofit organization devoted to finding ways to deliver appropriate healthcare to minority communities.

“We know that there are biological reasons for how medicines affect people differently. We also know that different groups are underrepresented in clinical trials,” says Jocelyn B. Ulrich, director for scientific and regulatory affairs at PhRMA.

So about two years ago, the groups began to look for ways to increase the number of minority participants in the trials.

Having identified two significant aspects of the problem as lack of awareness and access, they focused on reaching out.

The National Minority Quality Forum, along with a host of collaborators, created The Clinical Trial Engagement Network online at ctengagementnetwork.com. The secure Internet-based site connects patients, clinical trial sponsors, clinical investigators, healthcare professionals, their institutions, and advocacy organizations across the nation.

At joinimin.org, volunteers and patients can search for clinical trials as well as enter a pool to be considered for participation in future trials, and physicians who are not clinical trial investigators can register to become one.   IMIN2

Ulrich hopes that universities will help spread the word, “especially medical schools, nursing schools, et cetera.”

Ryan Haake, a genetics and immunology researcher at Northwestern University and an analyst at The Center for Healthcare Innovation, says diversifying clinical testing is key to getting better results for minority groups.

“We have a major problem: Drugs that may work for some do not necessarily work for all,” he says, speaking for the center. “We firmly believe that simply acknowledging diversity and inclusion as a top priority has the potential to reverse the trend from historically low minority enrollment.”

The need for volunteers is significant. Drugs go through three phases of study before they can be approved by the Food and Drug Administration for general use.

Phase one trials determine the safety of a drug by studying the effect on a small group of 20 to 100 healthy volunteers.

In phase two, the group is expanded to 100 to 500 volunteers, drawn from people who have the disease or condition the drug is designed to treat.

If a drug trial advances to phase three, a much larger group of 1,000 to 5,000 participants is needed to generate statistically significant information about the safety and efficacy of the drug.

The “I’m In” campaign is using social media to try to reach the vast number of people from varied communities.

Campaign materials are in Spanish and Chinese, as well as English. An All In for Better Health blog was created to discuss the need for diversity in clinical testing. The official campaign video can be seen at www.youtube.com/watch?v=uADB98q23Fk.

Ulrich says the campaign has made great strides in its first six months, generating much discussion online.

“We are tracking a lot of excellent social media data in terms of Twitter impressions and Facebook downloads and video views,” she says. “So the campaign has been quite successful. But ultimately it’s going to come down to improving the number of patients who participate in the trials.”

In August, the U.S. Food and Drug Administration issued its “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.”

The report encourages, but does not require, enhanced use of minorities as clinical testing subjects. The report identifies 27 short- and long-term goals that fall into three basic groups:

  • improving the completeness and quality of demographic subgroup data collection, reporting, and analysis;
  • identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation; and
  • making demographic subgroup data more available and transparent.


In announcing the plan, FDA Commissioner Margaret A. Hamburg called encouraging diversity in clinical trials “one of the core tenets of rigorous biomedical research.”

She said that the recommendations give the industry a solid framework for including minorities in product applications, and the result will be “greater assurance in the safety and effectiveness of the medical products used by a diverse population.”●