By Dr. Fredrick Ashbury, PhD and Susan Night, JD, LLM
A recent search of ClinicalTrials.gov reveals there are 5,078 phase I-III intervention studies actively recruiting cancer patients. Of these trials, 1,290 are sponsored by the National Institutes of Health, 2,778 are industry funded, and the balance of funding sources includes individuals, universities, organizations, and other government agencies. Phase III intervention studies alone represent slightly more than 10% of the trials in active recruitment (n=551).
Despite this significant activity in clinical research to identify treatments to improve patient outcomes, there has been abysmally poor recruitment of patients. Only 1 out of 20 cancer patients participates in trials, causing delays (or stoppages) in completing studies in a timely manner and revealing the potential of novel therapeutics being evaluated. Moreover, the generalizability of the results can be called into question given the disparities in representation of older adults, race, ethnicity, and rural patient enrollment.1,2,3
Clinical Trial Benefits
There are several benefits associated with clinical trials participation for patients, providers and practices.4,5 Most importantly, patients can access novel therapies otherwise unavailable outside of a clinical trial. Accordingly, there is the potential for an improved therapeutic outcome. Patients in both the treatment and control arms are more closely monitored and generally have more engagement/contact with their healthcare teams, thereby optimizing prevention and management of toxicities and facilitating ongoing trial participation. In addition, the financial costs of the interventions being evaluated are mostly covered by trial sponsors. Finally, patients can derive an altruistic benefit from their participation, because their involvement in the trial is contributing to a larger “public good”.
For Providers and practices can experience several benefits, as well, including financial, reputational and professional skill advantages. For example, having the capability to offer patients clinical trials, community oncology practices are more likely to retain patients and avoid the revenue losses associated with patients who switch to practices that offer trial opportunities.6 Moreover, in addition to cost avoidance, practices offering trials may attract new patients and thus generate incremental revenue, by being reimbursed by sponsors for operationalizing the trials and subsequent ongoing follow-up of the patients post enrollment in the studies.7 By demonstrating access to novel therapies through trials participation, contributing to knowledge generation and facilitating practice change, community oncologists can experience reputational recognition from patients and peers. Because 75 per cent of cancer patients are seen and treated in the community setting, it is an essential channel to optimize patient enrollment. Participation in trials by community oncologists can advance access and enhance patient outcomes.8
Cancer patients who are employed and their employers and society also benefit. Employees enrolled in clinical trials receive earlier toxicity management and therefore can remain at work, ease psychosocial sequelae, and continue to be productive, thereby mitigating presenteeism costs.9 Productivity losses associated with cancer mortality were estimated to exceed $150 billion last year10; hence, improving treatment outcomes through greater participation in clinical trials may have major financial benefits, in addition to reductions in loss of life. Employment tenure can be extended, and recruitment and replacement costs should reduce due to improved outcomes.11
Patient participation in clinical trials must improve. Community oncology is a key setting to expand access to studies, with benefits to patients, practices, providers and society. We acknowledge there are some resource issues that must be addressed to improve community oncology participation in trials. In an upcoming newsletter we discuss what can be done to facilitate capacity for and capability to deliver clinical research in the community practice setting, with an emphasis on technology, leveraging relationships, and organizational restructuring.
1 FDA DRUG TRIALS DATA, 2015-2019: https://www.fda.gov/media/143592/download
2 Trant AA, Walz L, Allen W, et al. Increasing accrual of minority patients in breast cancer clinical trials. Br Ca Treat & Res 2020;184:499-505
3 Saxton MC, Gonzalo M, Fearnley K, Rios P, Zaleta AK. Understanding barriers to clinical trials participation among older adults. Journal of Oncology Navigation & Survivorship 2020;11(11):411-412.
4 Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Cont Clin Trials Comms 2018;11:156-64
5 Wong AR, Sun V, George K, et al. Barriers to participation in therapeutic clinical trials as perceived by community oncologists. JCO Oncology Practice 2020 16:9, e849-e858
6 McAlearney AS, Song PH, Reiter KL. Why Providers Participate in Clinical Trials: Considering the National Cancer Institute’s Community Clinical Oncology Program. Contemp Clin Trials. 2012 November ; 33(6): 1143–1149.
7 Song PH, Reiter KL, Weiner BJ, et al. The Business Case for Provider Participation in Clinical Trials Research: An Application to the National Cancer Institute’s Community Clinical Oncology Program Health Care Manage Rev. 2013 ; 38(4): 284–294.
8 Ersek JL, Graff SL, Arena FP, Kim ES. Critical aspects of a sustainable clinical research program in the community-based oncology practice. ASCO Education Book 2019;39:176-84.
9 McGregor A. Ashbury FD, Caputi P, Iverson D. A Preliminary Investigation of Health and Work-Environment Factors on Presenteeism in the Workplace. J Occup Environ Med 2018;60(12):e671-8
10 Bradley CJ, Yabroff KR, Dahman B, et al. Productivity costs of cancer mortality in the United States: 2000-2020. J Natl Cancer Institute 2008;100(24):1763-70
11 Blinder VS, Gany FM. Impact of Cancer on Employment. Journal of Clinical Oncology 2020;38(4):302-308.
Fredrick D. Ashbury, PhD
Chief Scientific Officer, VieCure Professor (Adj), Department of Oncology University of Calgary Professor (Adj), DLSPH, University of Toronto
Susan Night, JD, LLM
VP Site Engagement & Network Strategy, TD2