Pre-pandemic oncology was both the largest and fastest growing therapeutic area in the clinical trials…
Global Leaders in Number of Clinical Trial Participants Today
Clinical research is becoming more complex, with more clinical trials than ever.
According to the FDA’s 2015 – 2016 Global Participation in Clinical Trials Report the global leader contributing the most clinical trial participants was the United States at 30.999% of total trial participants globally. The 5 countries contributing the highest number of total trial participants globally next to the U.S. are Canada (3.60%), Chezchia (3.69%), Germany (4.40%), Poland (3.92%) and Russia (5.22%).
Why the steadily Increasing Need for U.S. Trial Expansions?
Of all the Center for Drug Evaluation Research (CDER) approved novel drugs cited in the 2015-2016 report, 71-93% included study participants from outside the U.S. The referred drug approvals were granted either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).
The U.S. population’s growth is estimated at 11%, with those over age 65 increasing by 50%. This is expected to be the most significant factor contributing to a growing physician shortage in the U.S. and is anticipated to reach a shortfall of up to 120,000 physicians by 2030 in both primary and specialty care.
In addition, according to a 2016 study conducted for the of Memorial Sloan Kettering Cancer Center (MSK) of 1,500+ consumers and nearly 600 U.S. physicians, it was found that a large majority of Americans are reluctant to participate in clinical research. In this study no more than 35% indicated they were “likely” to enroll in a clinical trial, while other studies indicate only 4% of American cancer patients enroll in clinical trials nationally each year.
“If this trend of low enrollment continues, we will face a crisis in cancer research and discovery” is the concern José Baselga, MD, PhD, Physician-in-Chief and Chief Medical Officer at MSK Cancer Center expresses in light of these survey findings.
Where to Look for Clinical Trial Investigators and Participants?
A study conducted by the European Society for Medical Oncology (ESMO) in 2014 indicates the number of medical oncologists in Western Europe is keeping pace with cancer rates. However, it also identified a significant lack of information about the situation in Eastern Europe. At the same time, other source findings indicate that the physician to population ratio in the EU in general is steadily growing.
In Canada too which ranks 5th among countries (excluding the U.S.) that contribute the greatest number of clinical trial participants globally, according to a 2016 summary report on physicians by the Canadian Institute for Health Information, the number of physicians per population also increased in Canada for the 10th year in a row. With the number of physicians in Canada expected to continue to increase for the next several years.
In addition, given the nature of the health care system in Canada, patients are funneled through select oncology health centers across the country and will typically receive treatment at the same center throughout the evolution of their disease (1st, 2nd line, 3rd line, etc). A factor that helps facilitate the identification of possible study participants. While the overall population in Canada is smaller than in the U.S., participation by Canadians in oncology clinical trials is 14%. Nearly triple the 5% rate of participation by Americans.
Contributed by: Julie Martin, Director, Clinical Operations
American Association of Medical Colleges https://news.aamc.org/press-releases/article/workforce_report_shortage_04112018/
Canadian Institute for Health Information https://secure.cihi.ca/free_products/Physicians_in_Canada_2016.pdf
Memorial Sloan Kettering Cancer Center https://www.mskcc.org/press-releases/despite-pressing-need-survey-finds-most-americans-unlikely-enroll-clinical-trials
National Center for Biotechnology Information https://www.ncbi.nlm.nih.gov/books/NBK50888/
U.S. Food & Drug Administration https://www.fda.gov/media/106725/download