BALTIMORE — The Green Park Collaborative (GPC), sponsored by the Center for Medical Technology Policy (CMTP), has released a new report that provides guidance for researchers who lead oncology drug trials that may involve substantial treatment switching. Treatment switching most often occurs when a patient moves from the control to the experimental group during a clinical trial – for example, because the patient’s disease has progressed and they want to try the experimental treatment.
The guidance document provides best practice recommendations to ensure that a drug trial can permit such switches and still generate scientifically valid results.
“Oncology trials with high rates of treatment switching can be difficult to evaluate for regulatory purposes, and are particularly problematic in the assessments done to inform coverage and payment decisions. Uncertainty about how payers and guideline developers evaluate these trials is a major challenge for oncology drug developers,” said Sean Tunis, President and CEO at CMTP.
The guidance document provides recommendations on whether and when to allow treatment switching in a trial, identifies three analytical methods to adjust for treatment switching, and explains how to design clinical trials so the analytical adjustment methods can best be used. When appropriate information from outside the trial is available, potentially including observational data, it also can be used to help support the analytical adjustments.
Two critical times
The document additionally identifies two critical times when patients must be provided with key information about treatment switching as part of the informed consent process, as well as the content of that information. Other recommendations outline the data analyses and rationales related to treatment switching that should be provided to those who will ultimately make decisions about the value of the drug, such as regulators, HTA entities, and payers.
“Input from multiple stakeholders made it clear that clear communication is critical in all stages of this process,” said Tunis. “We recommend that study design teams involve patients and other stakeholders early in the clinical development process, identify the analytical method to be used prior to conducting trials, and document the rationale for key decision throughout study implementation.”
The guidance document was developed with input and guidance from a diverse team of expert stakeholders, including payers, HTA organizations, patients, clinicians, methodologists, statisticians, and pharmaceutical industry representatives. Over the course of 18 months, the team reviewed initial best practice recommendations, developed a draft guidance document based on input obtained during an in-person multi-stakeholder meeting, and engaged participants and external experts in a multi-round open comment process, culminating in the final set of best practice recommendations.
“This GPC report providing best practices makes a significant contribution to helping resolve the many concerns involved with treatment switching,” said Professor Lloyd Sansom, past chair of the Australian Pharmaceutical Benefits Advisory Committee for more than a decade. “It clearly identifies and addresses the key issues and its recommendations should help provide clarity and consistency for study designers, regulators, and health technology assessors, in addition to patients and clinicians.”
About the Green Park Collaborative-USA
The Green Park Collaborative-USA (GPC) is a multi-stakeholder forum that was established to guide the generation of clinical evidence needed to inform healthcare treatment and coverage decisions in the United States. GPC is a major initiative of the Center for Medical Technology Policy (CMTP). GPC members include a diverse mix of payers, life sciences companies, patients, clinicians, researchers, and regulators. GPC convenes working groups to develop condition and technology-specific study design recommendations that focus on real-world effectiveness and value, meet the evidence expectations of payers, and are informed by the views of patients and clinicians. – USNewswire