PhRMA To Assist Pay-For-Locate Trial Enrollment Tool To Boost Study Diversity

PhRMA takes an active role in shaping a new National Clinical Trial Network that aims to speed up enrollment of diverse study populations as FDA increases its push for minorities in clinical research.

The Pharmaceutical Research and Manufacturers of America is joining with the National Minority Quality Forum and Microsoft to help design the National Clinical Trial Network (NCTN), a soon-to-be-released tool pharmaceutical companies can use to determine where to best locate clinical research to increase patient enrollment, particularly of minority populations.

The tool could prove useful for drug companies who want to avoid labeling qualifications that single out inadequate data in subpopulations or requirements for additional postmarketing studies. It comes as FDA’s relatively new Office of Minority Health focuses greater attention on study diversity (Also see "Jonca Bull Brings Clinical Experience To FDA Minority Health Office" - Pink Sheet, 31 Jul, 2012.).

In conjunction, PhRMA will also be spearheading a media effort to build awareness among patients, healthcare providers and other stakeholders about the need for minority involvement in clinical trials.

PhRMA will be providing funding for the national education campaign and it will likely help design the communication efforts as well, said Bill Griffith, senior VP of the National Minority Quality Forum’s National Health Index (NHI), which is leading the NCTN effort for the forum, a nonprofit research and education organization that aims to improve healthcare quality for all populations.

The NCTN will utilize big data to help pharmaceutical companies speed trial enrollment by locating areas where key patient groups are concentrated, and linking researchers to physicians whose diversity of patients may be candidates for clinical trials.

Paying To Avoid Costly Delays

The network is expected to be introduced in the fourth quarter and will make use of Microsoft software and healthcare information compiled by the NHI. Companies will pay to utilize the service.

The fee will be based on the amount of access firms need to the clinical trial network, and Griffith said he expects the NCTN would benefit a company’s bottom line. He estimates the service might cost several thousand dollars per patient but also noted the high cost of patient recruitment, which could for example sometimes cost a company about $20,000 to $35,000 per patient, he estimated.

Lagging trial enrollment is “worrisome,” Salvatore Alesci, VP of scientific affairs at PhRMA, said. Depending on the statistics that you read, up to about 90 percent of trials may not complete enrollment in time, he said. “The delay in enrollment means cost.”

FDA Focusing On Minority Enrollment

Insufficient trial data for minority populations has led to drug labeling caveats or requirements for more studies that industry likely wants to avoid. For instance, FDA’s approved labeling for two hepatitis C drugs, Vertex Pharmaceuticals Inc.’s Incivek (telaprevir) and Merck & Co Inc.’s Victrelis (boceprevir) in 2011 that note clinical trials showed lower efficacy results for black/African American patients. Vertex also had to agree to study the drug in blacks/African Americans, while Merck avoided this due to including more black/African American patients in its pivotal trials and conducting a pre-specified subanalysis (Also see "Telaprevir Labeling Advantages Should Offset Higher Price In Hepatitis C Battle" - Pink Sheet, 30 May, 2011.).

In another instance labeling for GlaxoSmithKline Inc.’s lupus drug Benlysta (belimumab) says that no definitive conclusions can be drawn from clinical trials about the drug’s effect on blacks/African Americans. African American women make up a larger market for the treatment, however, as they have three times a higher incident rate for the disease than Caucasian women (Also see "HGSI/GSK's Benlysta Gets BLySfully Clean Labeling, Escaping Feared Restrictions" - Pink Sheet, 10 Mar, 2011.).

PhRMA’s June 18 announcement also follows an Office of Minority Health announcement on its efforts to increase participation of people in racial, ethnic and other minority groups in clinical trials and the importance of such diversity in drug reviews. Women and minorities have historically been underrepresented in clinical trials, yet are important to study because biological differences can impact how people process drugs and can have implications for drug effectiveness and severity of side effects, FDA says.

“Potential ethnic and other differences in response to drugs are important to FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved,” Office of Minority Health Director Jonca Bull said in an FDA April 26 web announcement. “Getting more data on these differences is essential for FDA to truly know that a medical product will truly work and be safe for all patients,” she added.

NHI’s Griffith said FDA is expected to make another announcement in late June about the need for more minorities in clinical trials, but said he is not privy to additional details or “how much teeth” such an announcement might have in compelling or mandating greater study diversity and the FDA did not respond to a request for additional information by press time.

“Define A Disease Down To A Zip Code”

Meanwhile, the NHI through the NCTN will be able to “define a disease down to a zip code level,” to indentify where a disease is most prevalent, Griffith explained. NHI can point to where the most minority patients and patients who might benefit from a particular therapy live.

The large institutions where trials are frequently conducted often don’t have large minority patient populations, Griffith said. “We can help tell industry where they should be putting their trials, where the patients are.”

NHI collects its data from the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Service, state epidemiology departments, hospital database, patient registries and other sources.

The group is also building an interactive community to link practicing physicians with researchers and will maintain searchable profiles of clinical research institutions, experienced clinical investigators as well as minority-serving hospitals and advocates.

For example, Griffith said if a company was looking to do a diabetes study and found that in a particular section of Chicago there was a large population of minority diabetes patients, NHI could overlay its directory of investigators and disease advocates in this location to help facilitate the recruitment process.