By Kris Gustafson, Vice President, Global Head Patient Centered Technologies, IQVIA and Piero Bindi, Associate Director, eCOA Library, IQVIA
As the pharmaceutical industry continues to move towards a more comprehensive picture of treatment benefits for new drugs in development, patient reported outcomes have become a new benchmark for regulators and payers to measure the quality of a drug or therapy. This shift has made Clinical Outcome Assessments (COAs) an increasingly necessary and often required tool in the clinical research landscape.
COAs offer a direct line to patients, capturing insights about experiences with their disease, the trial, and its impact on their quality of life. And now electronic COAs, or eCOAs, are enabling this in real time. These insights give patients a chance to be heard while providing sponsors with patient-relevant endpoints to better understand the impact and efficacy of a treatment. Capturing insights directly from patients helps researchers design trials around their needs, while increasing the likelihood of drug approval and reimbursement.
However, creating and validating a COA in an electronic format adds months to the trial planning process. Sponsors can spend 12–16 weeks at a minimum building an assessment in an eCOA system, validating it against standards, qualifying it with relevant approvers, and adjusting/translating the tool as necessary. In many cases, revision and approval delays cause this planning step to extend well beyond the deadline, delaying first-patient- in milestones, which can drag the entire schedule off track.
This adds time and cost to the trial. It also increases the risk that the questions they ask will vary from assessment-to assessment, making it more difficult to compare results across trials or patient populations.
Historically, sponsors have repeatedly re-created standard eCOAs for every trial, but what if they didn’t have to? The industry has enough experience in eCOA development and validation that sponsors could leverage existing assessments in new trials with minimal or no modifications.