| Popis: |
Oncology clinical trials generate the evidence required to obtain regulatory approval for new interventions; the life-saving treatments cancer patients receive today, and the novel therapies that will transform future care paths, rely on data from clinical trials. Unfortunately, the therapeutic advances driven by clinical research are limited to the patient populations that best represent those enrolled in clinical trials. The explicit driver of this limited generalizability is the design of clinical trial eligibility criteria. Although overly restrictive eligibility criteria have been critiqued in the literature, quantitative studies evaluating the appropriateness of these criteria have not been performed. Therefore, we analyzed the eligibility criteria of a particular oncology disease group (hematologic malignancies), specifically exploring: 1) the relationship between commonly used organ function eligibility criteria and the expected toxicities of the trials’ interventions, 2) reasons for ineligibility and the outcomes of leukemia patients eligible vs. ineligible for South Western Oncology Group (SWOG) trials, and 3) the health policy implications of overly restrictive eligibility criteria. Collectively, the findings of these studies suggest that the eligibility criteria for hematologic malignancy clinical trials are overly restrictive; the organ function criteria fail to reflect the expected toxicities of the trials’ interventions / observed adverse events and the administrative criteria associated with the timing of screening tests / sample submissions included in SWOG leukemia protocols are too conservative. Furthermore, our results demonstrated the safety and efficacy outcomes were comparable between the leukemia/myelodysplastic syndrome patients ineligible for administrative or non-clinically significant reasons and the patients fully meeting the eligibility criteria. These findings suggest, patients who may benefit from potentially life-saving treatments available through clinical trials are denied access to these interventions. Consequently, overly restrictive eligibility criteria, resulting in the systemic exclusion of specific patient populations, diminishes the generalizability of the trials’ results, leading to poorly designed health policy decisions, particularly within the context of value-based provider reimbursement. |
