Year: 2007
Type: letter
Abstract: Tam-McDevitt et al. (1) recently queried the National Institutes of Health Web site for all open US trials of breast, lung, or prostate cancers. They excluded trials that involved more than one type of cancer and counted 50% of the accrual goal for trials that also recruited participants from other countries. They found that the number of participants needed to complete these trials represented 58.7%, 15.4%, and 22.7% of the estimated new cases of breast, lung, and prostate cancers, respectively, in the United States for the year 2005. They concluded that for some types of cancers, the demand for trial participants might be outpacing the current supply (1) . This suggestion is inaccurate. Tam-McDevitt et al. may not have accounted for several factors in their study that could potentially inflate the results of their calculations. First, they should have excluded trials that allow concomitant participation in another treatment trial (i.e., supportive care trials, nontherapeutic trials, and surgical trials for primary cancers that do not include a systemic or radiation therapy component). Second, it would be more appropriate to count 50% of the accrual goal only for trials that included both previously treated and untreated patients because patients diagnosed from previous years would also be eligible. Examples of such trials include those for stage IV cancers that allowed newly diagnosed patients as well as patients who were previously diagnosed with earlier stage disease and had relapsed. Third, most trials are designed with a timetable of several years to complete accrual because the time it takes for a trial to be approved varies considerably among institutions (i.e., from several months to more than a year). Even assuming that there is an overwhelmingly great demand for a specific trial, it is generally not possible for a trial (especially a phase III trial) to be completed within 1 year of activation. Consequently, the trial sponsor is unlikely to open another trial that would accrue a similar patient population until the earlier trial is completed. Moreover, two prospective studies that examined clinical trial accruals at both academic and community-based cancer centers reported a lack of trials appropriate for the types and stages of cancer diagnosed in more than 50% of the new patients ( 2 , 3 ). Hence, we performed a reanalysis using clinical trial information obtained from the National Cancer Institute Web site (4) to ask whether the demand for clinical trial participants has outpaced the supply. We used the same search criteria as Tam-McDevitt et al. but also took into account the additional factors noted above. Estimates of the 2007 incidence rates for specific cancers were obtained from the American Cancer Society (5) . Even though we used appropriate Web filters to specifically look for trials that were accruing new patients, a large proportion of the trials were subsequently excluded because they were in fact studies for previously treated patients. We found that the numbers of participants needed for trial completion represent only 32.8%, 5.5%, and 7.0% of the estimates of the numbers of new cases of breast, lung, and prostate cancers, respectively ( Table 1 ). Number of patients needed to complete clinical trials relative to American Cancer Society (ACS) 2007 incidence estimates Number of patients needed to complete clinical trials relative to American Cancer Society (ACS) 2007 incidence estimates We therefore conclude that there is a lack of clinical trials for new cancer patients in the United States. The demand for clinical trial participants has clearly not outpaced the supply and is unlikely to do so in the near future.
DOI: 10.1093/jnci/djm001
Authors: R. S. Go, L. A. Meyer, K. A. Frisby
Institutions: Gundersen Health System, Gundersen Lutheran Hospital
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2139574172