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Treatment Switching

overview

Managing Trial Data When Patients Switch Treatment Groups

Although allowing patients in the control group of a clinical trial to switch onto the experimental treatment is a common occurrence in oncology drug trials, it can present significant challenges for the accurate interpretation of trial findings when a substantial number of patients switch treatments. A GPC team is now exploring how to manage treatment switching in the design and analysis of oncology drug trials, to help ensure that the trial results are meaningful and appropriately construed.

participation

Sponsors Providing Support for This Project Include:

Astra Zeneca, Bellbery, Johnson & Johnson, Roche, Merck & Co.

Participants include:

Aetna, ASCO, ASH, CADTH, EMA, ECRI, FDA, Friends of Cancer Research, NICE, NCCN, Australian Department of Health, University of Adelaide, Humana, Johns Hopkins Medicine and Johns Hopkins University, Genentech, Pfizer, University of Maryland, Merck, University of Leicester, University of Sheffield, University of Queensland, University of Alberta, the University for Health Sciences, Medical Informatics, & Technology.

There are many ways for qualified experts to get involved in this project -- as sponsors, key stakholders, or in other key informant roles.  For more information, contact project coordinator Marty Johnson at 410.547.2687, or via email

activities

Working Toward Consensus

The October 22 and 23 stakeholder workshop addressed key issues identified at a 2014 meeting hosted by Bellberry Limited in Australia, while bringing in the context of North American health care systems. Participants worked toward consensus on optimal approaches to managing treatment switching in oncology drug trials. Participants included patients and patient advocates, representatives from payers, health systems, health technology assessors, the pharmaceutical industry, FDA, clinical guideline and compendia developers, researchers, and others.

The meeting was part of a 12-month process that will lead to an Effectiveness Guidance Document (“EGD”) with specific recommendations on managing treatment switching in the design, conduct, analysis, reporting, and assessing of oncology drug trials when treatment switching has occurred.

goals

Recommendations: Coming Soon!

The team is on track to produce an EGD that should provide greater clarity and consistency about the expectations of payers, guideline developers, healthcare technology assessors, and other key decision makers when assessing evidence from oncology drug trials in which treatment switching has occurred. The EGD is targeted for completion in mid-to-late 2016.