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Views of American oncologists about the purposes of clinical trials
1Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. steven_joffe@dfci.harvard.edu
Background:
Many research subjects believe incorrectly that the primary purpose of clinical trials is to benefit the participants rather than to improve therapy for future patients. However, few data are available about how physicians view trials.
Methods:
We mailed surveys to a stratified random sample (n = 1120) of U.S. medical, pediatric, and other oncology specialists who were selected from the American Society of Clinical Oncology Membership Directory. Respondents were asked to select, from a list of options, their reasons for enrolling individual patients in trials and what they thought the main societal purposes of clinical trials are. We used logistic regression models to evaluate which demographic and clinical practice characteristics were associated with responses to these questions. All statistical tests were two-sided.
Results:
Of the 547 physicians (48.8%) who responded, 40.5% of the medical oncologists, 32.3% of the pediatric oncologists, and 62.6% of the other oncology subspecialists reported enrolling individual patients in clinical trials to improve future therapy. Most of the other respondents reported enrolling patients to ensure that they received state-of-the-art treatment. When asked about the main societal purpose of clinical trials, 72.7% of the medical oncologists, 59.4% of the pediatric oncologists, and 81.9% of the other oncology subspecialists cited improving future therapy; most of the other respondents cited ensuring state-of-the-art treatment for participants. In multivariable analysis, medical oncologists (odds ratio [OR] = 0.6, 95% confidence interval [CI] = 0.3 to 0.9) and pediatric oncologists (OR = 0.3, 95% CI = 0.2 to 0.5) were less likely than other oncologists to identify improving future therapy as the main societal purpose of clinical trials, whereas industry physicians (OR = 4.6, 95% CI = 1.1 to 20.5) chose this option more often than physicians who did not work for industry.
Conclusions:
Many respondents viewed the main societal purpose of clinical trials as benefiting the participants rather than as creating generalizable knowledge to advance future therapy. This view, which was more prevalent among specialists such as pediatric oncologists that enrolled greater proportions of patients in trials, conflicts with established principles of research ethics.
Insights
Physicians often view clinical trials as benefiting participants, not advancing future therapy. This perspective, particularly among pediatric oncologists, conflicts with research ethics principles.
Area of Science:
- Oncology
- Clinical Research Ethics
- Medical Practice
Background:
- Patient perception of clinical trials often prioritizes individual benefit over future therapy advancement.
- Limited data exists on physician perspectives regarding the primary purpose of clinical trials.
Purpose of the Study:
- To investigate oncologists' views on the primary purpose of clinical trials.
- To determine physician motivations for enrolling patients in clinical trials.
- To identify factors influencing physicians' perceptions of clinical trial societal goals.
Main Methods:
- A survey was mailed to a stratified random sample of 1120 U.S. oncology specialists.
- Respondents indicated reasons for patient enrollment and perceived societal purposes of trials.
- Logistic regression models analyzed associations between physician characteristics and responses.
Main Results:
- A significant portion of oncologists enrolled patients for state-of-the-art treatment rather than future therapy improvement.
- Perceptions of clinical trials' main societal purpose varied by subspecialty, with some prioritizing participant benefit.
- Medical and pediatric oncologists were less likely than other specialists to view improving future therapy as the primary societal purpose.
Conclusions:
- Many physicians perceive clinical trials as primarily benefiting participants, contrary to ethical research principles.
- This perception is more common in specialties enrolling a higher proportion of patients in trials.
- Aligning physician understanding with the core principles of advancing generalizable knowledge is crucial.
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