Today, the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) in cooperation with Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) announced the availability of multiple guidances, to include:
- Cancer Clinical Trial Eligibility Criteria: Patients with Human Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus Infections; Draft Guidance for Industry;
- Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients; Draft Guidance for Industry;
- Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies; Draft Guidance for Industry;
- Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Draft Guidance for Industry; and
- Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Final Guidance for Industry
A clinical trial’s eligibility criteria are essential components of the trial, defining the characteristics of the study population. Over time, some eligibility criteria have become commonly accepted or used as a template across trials without clear scientific or clinical rationale or justification, or based on an anticipated safety concern. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug.
The overall purpose of this series of draft guidances for Cancer Clinical Trial Eligibility Criteria is to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for the treatment of cancer. Including patients with the conditions covered by the guidances (HIV, HBV, HCV, organ dysfunction, prior or concurrent malignancies and brain metastases) will allow for trial results that better represent the patient population that will use the drug or biological product. Expanding eligibility criteria for pediatric patients for all relevant oncology trials may reduce the risks associated with off label use of oncology drugs and accelerate the development of therapies in this population. Expanding cancer trial eligibly criteria can maximize the generalizability of trial results and ability to understand the benefit-risk profile across the patient population likely to use the drug in clinical practice without jeopardizing patient safety. The FDA developed these guidances with appropriate input from stakeholders including American Society for Clinical Oncologists (ASCO) and Friends of Cancer Research.
The purpose of the guidance titled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials” is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials.
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