Journal of the National Cancer Institute Advance Access originally published online on June 12, 2007
JNCI Journal of the National Cancer Institute 2007 99(12):973-974; doi:10.1093/jnci/djm003
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© The Author 2007. Published by Oxford University Press.
CORRESPONDENCE |
Response: Re: Has Demand for Clinical Trial Participants Outpaced Supply?
Affiliations of authors: Geriatric Oncology Consortium, Baltimore, MD (JTM, RH); Senior Adult Oncology Program, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL (LB); Department of Medicine, Memorial Sloan-Kettering Cancer Center, Commack, NY (SL)
Correspondence to: Jennifer Tam-McDevitt, PharmD, PhD, Geriatric Oncology Consortium, 3600 Clipper Mill Rd, Ste 110, Baltimore, MD 21211 (e-mail: jtam{at}thegoc.org).
We thank Go et al. for their comments about our study, which has generated active discussions with various organizations since its presentation at the 2006 American Society for Clinical Oncology meeting.
Our finding that the demand for trial participants may be outpacing the supply was based on current estimates that only 5%–10% of all cancer patients participate in clinical trials. We recognize that there are limitations to this study and have discussed them in our American Society for Clinical Oncology presentation. Space limitations in the Correspondence section precluded a full discussion of the limitations; we welcome the opportunity to do so here.
First, the use of incidence numbers as a point of comparison is likely to overestimate the percentage of patients needed for the completion of the evaluated trials. Indeed, it was not our intent to include only new patients. We felt it was important to look at all active trials to give a more complete picture of the current clinical trial landscape. Second, even though many of the trials included in our study had an enrollment period that spanned several years, we believe that the number of trial participants needed is still quite daunting based on the current participation rate. Go et al. suggested that a trial sponsor is unlikely to open another trial that would accrue a similar patient population until the earlier trial is completed. However, given that clinical trials can be sponsored by independent sponsors (i.e., academic centers, government agencies, and pharmaceutical companies), it is possible that concurrent trials will enroll similar population of patients. Hence, our suggestion on the importance of an open dialog among these organizations to discuss potential prioritization of studies as well as other factors such as effective patient enrollment strategies. Indeed, our study results may underestimate the number of patients needed to complete the existing trials because not all currently recruiting trials may have been included in the clinical trials registry we searched and not all trials in the registry specified the recruitment goal (i.e., 12.8% of lung cancer trials, 8.5% of breast cancer trials, and 7.1% prostate cancer trials did not specified number of patients needed).
Go et al. mentioned two studies (1,2) that examined clinical trial accruals at both academic and community-based cancer centers and reported a lack of trials appropriate for the types and stages of cancer diagnosed in more than 50% of new patients. Because not all patients are eligible for the existing trials, this finding actually supports our conclusion that the demand may be outpacing the supply given that only 5%–10% of all cancer patients participate in clinical trials. Go et al. found that 32.8% of new breast cancer patients would be needed to complete the breast cancer trials, which further supports our conclusion that, given the current trial participation rate, the completion of existing trials for some tumor types may be problematic.
As more anti-cancer agents are being developed and tested in clinical trials, it is important to increase the awareness and understanding of clinical trials and to address organization infrastructure issues to ensure adequate patient accrual and the timely completion of clinical trials. Studies designed to address the underrepresented trial participants (such as older cancer patients) will also be needed to help answer pertinent questions.
REFERENCES
(1) Lara PN Jr, Higdon R, Lim N, Kwan K, Tanaka M, Lau DH, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol (2001) 19:1728–33.
(2) Go RS, Frisby KA, Lee JA, Mathiason MA, Meyer CM, Ostern JL, et al. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer (2006) 106:426–33.[CrossRef][Web of Science][Medline]
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J Natl Cancer Inst 2007 99: 973.
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