Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs
By Paul Robinson of Merck Sharp & Dohme
One of the key factors in the future success of any MAPPs implementation will be the need for continuous monitoring, in health data registries, of how patients respond to new therapies. On January 17th, 2017, the ADAPT SMART consortia hosted a multi-stakeholder workshop to explore the ethical and legal considerations of MAPPs and the uncertainties of patients. The workshop covered several topics including the use of patient data in registries.
Patients are keen to be fully informed on the benefits and risks of new therapies introduced in MAPPs, as well as any uncertainties around previous testing and research. If there is a clear understating of what they could reasonably expect, they were willing to participate in data sharing and the use of registries in MAPPs.
However, there was some concern expressed for making the participation in these registries mandatory, which according to the patients, depended on the reasons for the data collection.
If the registry data collection was for monitoring, for example, dose response or adverse events – in other words, directly related to patient safety – this was generally accepted, and seen as a direct benefit to patients. In contrast, if the registry collection was related specifically to the generation of evidence related to licensing or reimbursement decisions, this was seen by some patients as something that should be optional and would require a patient to have the choice of opting in or out of the data registry.
There are many new examples of effective therapies that use some type of MAPPs-like flexible prescribing practices based on patient responses such as, the IO Checkpoint treatments. However, the fact remains that the need for MAPPs to monitor patients in registries can be perceived to blur the lines between clinical impact assessment vs. clinical trial use, in the minds of patients. What this means, practically for ADAPTSMART, is that whenever data collection is part of MAPPs, the nature of that data collection will need to be flexible to the needs and concerns of patients – their willingness to participate will be directly related to the reason the data is being collected.
An official report of the workshop, covering all the topics discussed, will soon be published on the ADAPT SMART website. I’d like to thank my colleagues Valentina Strammiello of the European Patients Forum and Stuart Faulkner of CASMI in the organisation of this round table and the preparation of the report.