Related Experiment Videos
Evaluating the benefit of clinical trials to future patients
Abstract:
Large, multicenter clinical trials are expensive to design and to carry out. In spite of the magnitude of expenditures for such endeavors during the past two decades, little attention has been given to evaluating the impact of findings from these trials on those who are expected to benefit from them, i.e., future patients to whom trial findings apply. The implications of failure to demonstrate that results from these large medical experiments have been accepted by medical practitioners and policy makers and applied appropriately to patients must be of concern to all advocates and practitioners of controlled trials. Of the 20 evaluation studies reviewed in this paper, 6 were directed at assessing dollar benefits to the patient or to society. The remaining 14 studies were concerned primarily with physician knowledge and acceptance of trial findings. Investigators and sponsors of each large trial have a responsibility to develop an evaluation strategy during the planning phase of the trial, to publicize findings from the trial, to evaluate the impact of the findings on future patients, to act in response to the results of the evaluation, and to foster integration of findings into patient care policy.
Insights
Clinical trial results require evaluation to ensure patient benefit. Investigators must plan for impact assessment and integrate findings into patient care.
Area of Science:
- Clinical Trials
- Health Services Research
- Medical Research Evaluation
Background:
- Large, multicenter clinical trials incur significant costs.
- Insufficient attention has been paid to evaluating the real-world impact of clinical trial findings on future patients.
- Failure to ensure adoption and appropriate application of trial results by practitioners and policymakers is a concern.
Purpose of the Study:
- To review existing studies evaluating the impact of large clinical trials.
- To highlight the responsibility of trial investigators and sponsors in assessing and integrating trial outcomes.
Main Methods:
- Review of 20 evaluation studies on clinical trial impact.
- Categorization of studies based on evaluation focus: economic benefits (6 studies) or physician knowledge/acceptance (14 studies).
Main Results:
- Most reviewed studies focused on physician knowledge and acceptance rather than direct patient or societal economic benefits.
- A gap exists in evaluating the translation of clinical trial findings into patient care and policy.
Conclusions:
- Investigators and sponsors must proactively plan for trial impact evaluation.
- Strategies should include publicizing findings, assessing patient impact, responding to evaluations, and integrating results into patient care policy.