CTTI publishes framework for estimating the impact of patient engagement on key business drivers

To fully realize the impact of patient engagement in clinical trials, there is a need for robust and rigorous study of its quantitative effects on research and development. To begin to address this gap, CTTI recently published an approach for assessing the financial value of patient engagement that accounts for the business drivers of cost, risk, revenue, and time.

In a set of recommendations published along with the financial model, CTTI’s Patient Groups & Clinical Trials Project team outlines “rules of engagement” for successful collaborations between research sponsors and patient groups around clinical research. Together, the articles in Therapeutic Innovation & Regulatory Science (TIRS) provide a blueprint for establishing effective patient group engagement in research programs.

While research sponsors are increasingly partnering with patients in the design and conduct of clinical development programs, sponsors may be reluctant to go beyond pilot initiatives because of uncertainty in the return on investment. The new CTTI article describes a novel approach to quantifying the financial impact of patient-centric initiatives using risk-adjusted financial modeling techniques that integrate key business drivers into a summary metric (expected net present value). Expected net present value (ENPV) is a widely used metric by industry for project strategy and portfolio decisions.

Drawing on published data to develop a case study for a typical oncology development program, the authors also show how patient engagement activities that avoid a protocol amendment or improve the patient experience can contribute considerable financial value.

Ongoing work by CTTI’s Patient Groups & Clinical Trials Project is examining how sponsors and patient groups characterize the benefits of patient engagement and investments required for engagement. Along with the ENPV model, the project aims to provide resources to assist in determining which of the many engagement opportunities provide the greatest value.