An effort to gain more control over recruitment costs and encourage more diversity in clinical trials has taken another step toward starting to engage minority communities and find more research subjects.

“I’m In,” a campaign intended to increase minority representation in clinical trials, launched March 12 with a website to engage minority communities and find more patients and physicians interested in research as well as gather information from prospective trial participants.

Sponsored by the Pharmaceutical Research and Manufacturers of America and the National Minority Quality Forum, it is an extension of the Clinical Trial Engagement Network, a database also intended to improve minority inclusion in trials.

The Clinical Trial Engagement Network was renamed after its announcement in 2013 as the National Clinical Trial Network Also see "PhRMA To Assist Pay-For-Locate Trial Enrollment Tool To Boost Study Diversity" - Pink Sheet, 19 June, 2013..

The I’m In website will allow patients to submit personal data expressing interest in research and other information, search for trials and volunteer as a research subject.

Site registration does not require the person to join a trial, but sponsors could receive de-identified information to gather a list of potential trial participants.

The Clinical Trial Engagement Network website can help sponsors with patient recruitment and trial site selection. Its database includes zip code-level disease cluster maps and links to community resources.

Gary Puckrein, National Minority Quality Forum president and CEO, said he hoped to have 100,000 to 150,000 people signed up through the website after two years.

“What we are encouraging patients and physicians and investigators is really to join in a lifelong relationship,” Puckrein said.

PhRMA President and CEO John Castellani said following a press event launching the campaign that it could help control increasing clinical trial costs.

Recruitment is among the most expensive parts of a clinical trial for sponsors. The Clinical Trial Engagement Network, which is partially funded by PhRMA, could at least help contain some of the burden.

Growing clinical trial costs are not a new problem for industry and there are several reform efforts ongoing. The Biotechnology Industry Organization announced recently that it wanted to help boost the most promising ideas Also see "BIO Looking For Clinical Trial Reform Priorities" - Pink Sheet, 23 January, 2013..

Trial Access An Issue Along With Diversity

Diversity among subgroups in clinical trials has gained attention in recent years with the rise of personalized medicine. Sponsors and FDA are determining more frequently that different populations react to drugs differently.

Yet clinical trials have not been well-represented by minority groups. Some participants are reluctant in part because of a distrust of researchers by minority groups.

Health facilities serving mostly minority populations also need more access to trials, said Carlos Cardenas, a physician at Doctors Hospital in McAllen, Texas.

FDA was mandated in the 2012 FDA Safety and Innovation Act to recommend ways to improve the completeness and quality of demographic subgroups in product labeling.

In a report published in 2013, the agency determined that some demographic subgroups were underrepresented. The agency said diverse trials were important and that it wants to determine clinically meaningful differences among demographic groups. But it also questioned whether demographic groups as currently identified would relate in the era of targeted medicines ([A#00130826011]).

Campaign Can Open New Regions To Trial Participation

The I’m In website will be focused on the African-American, Asian-American and Hispanic communities.

Cardenas said among the problems at his facility has been gaining access to trials once they are launched.

“When you look at the size of the population we need more involvement in trials,” he said.

Doctors Hospital is located near the Texas’ southernmost border with Mexico. Cardenas said the Hispanic population in his area is mostly untapped and should not be left out of trials in diseases like diabetes, which are prevalent among Hispanics.

FDA has pushed for a number of years for diabetes drug developers to enroll sicker patients in their trials Also see "Diabetes Drug Developers Urged To Study Higher Risk Patients By FDA Panel" - Pink Sheet, 27 April, 2009.. It asked sponsors to enroll more patients with liver disease to test drugs’ potential for liver injury Also see "Drug-Induced Liver Injury Workshop Offers More Questions Than Answers" - Pink Sheet, 7 April, 2008..

The agency also has made a more concerted effort recently to make sure clinical trials do not exclude patients that could potentially lend valuable information.

FDA recently issued a new Manual of Policies and Procedures document indicating that its staff should pay close attention to trial protocols and stop unnecessary exclusions.

The policy grew from concerns that older patients as well as those with some psychiatric conditions were not being included ([A#14140131002]).

PhRMA’s “I’m In” Campaign Looks To Connect Minorities To Studies

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