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Clinical Trial Diversity

Clinical trials are an integral part of the drug development process. Patient participation is crucial to the successful completion of a trial and of course without successful trials, approval for a drug cannot be granted. Yet, many clinical trials cannot enroll as many patients as desired, and the patients that do enroll are not necessarily fully representative of the population the drug will serve.  Some of the key facts in this regard are as follows:

  • 11 percent of clinical trials never enroll a single patient1
  • 37 percent are under-enrolled2
  • 83 percent of 55,689 clinical trial enrollees were white, 6 percent were African-American, 5.3 percent were Asian, 2.6 percent were Hispanic and 2.4 percent were classified as “other” between the years of 2003 and 20163
  • A national study in 2015 found that patient households making less than $50,000 annually were 30 percent less likely to participate in clinical trials4

With this as background, Amgen has supported an important effort to increase the enrollment and diversity of patients who participate in clinical trials.  In December 2018, Amgen and the Lazarex Cancer Foundation, a non-profit organization focused on improving patient access to cancer clinical trials, announced Amgen’s $2 million corporate donation to Lazarex’s IMPACT (Improving Patient Access to Cancer Clinical Trials) program. IMPACT evolved from a 3-year pilot study and is a comprehensive approach to improving patient enrollment, retention, minority participation and equitable access in oncology trials. What began as a pilot program with Massachusetts General Hospital has expanded to include 20 best in class cancer centers and public health programs nationwide, coordinating efforts amongst all stakeholders to make clinical trials more representative of the actual patient population.

The results of the pilot program with Massachusetts General Hospital saw a 29 percent increase in overall participation and minority participation in cancer clinical trials doubled. “The promise of the medicines that we make is only relevant if we are able to generate the safety and efficacy information needed to obtain regulatory approval of those medicines.  Clinical trials should be accessible to patients irrespective of ethnicity and socioeconomic factors and Lazarex offers a valuable and effective forum to offer support to patients who seek access to oncology clinical trials. This is why we are excited that Amgen is a founding sponsor of the IMPACT program,” stated Eduardo Cetlin, executive director, Philanthropy and Responsibility.

REFERENCES


  1. Tufts Center for the Study of Drug Development.  “89% of trials meet enrollment, but timelines slip, half of sites under-enroll”. Impact Report, Volume 15, Number 1
  2. Ibid
  3. Duma, N et al. “Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years”. Journal of Oncology Practice.2018 14:1. e1-e10
  4. Unger, J. et al. “Patient Income Level and Cancer Clinical Trial Participation in a Prospective Survey Study”.  JAMA Oncology 2016 Jan 1; 2(1): 137–139.
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