Event outline and objective
There is a need from regulators and HTA bodies for medicines to have a continuum of evidence generated from clinical trials which is then further complemented by data collected in routine clinical practice, so called Real World Data (RWD). The drive for this is to look beyond safety and efficacy parameters to gain marketing authorisation and instead look at benefits of the medicines in the real world setting to also inform reimbursement decisions better. For cancer medicines this is a burning platform. Development of initiatives such as Adaptive Pathways provides a mechanism for investigating these concepts further for medicines with smaller populations or unclear safety/benefit profiles. However, the utility of RWD ought to be focused on both accelerating drug development of cancer medicines and providing the confidence of true benefits in the real world setting. This can be demonstrated through review of case studies and examples of where RWD can best complement evidence generation to accelerate drug development and eventual reimbursement.
The aim of the workshop organized by the Cancer Drug Development Forum (CDDF) was to have a multi-stakeholder discussion representing regulators, clinicians, HTA / payers, and policy makers on the challenges of developing RWD proposals in Oncology and share current experience on the best sources of RWD of high quality in Oncology Drug Development to enhance development and access.
View the programme: CDDF Workshop on Real World Data – Final programme
The use of real-world data in cancer drug development
European Journal of Cancer (EJC), Volume 101, September 2018, Pages 69-76
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