MDIC PCOR Project: A brief summary of a novel method for incorporation of PCOR in clinical trial design

Oct 1, 2018Clinical, Patient Centered Outcomes Research (PCOR)

Patient Introduction

MDIC developed a novel method for incorporating patient-centered outcomes research (PCOR) into clinical trials designed with consideration of patient preference information. The goal is to expedite clinical trials and elevate the voices of smaller patient populations and patients with rare diseases.

Summary

For chronic, debilitating, and terminal illnesses with no effective treatments, the standard statistical threshold for determining therapeutic effectiveness in clinical trials may be too conservative and may not reflect patients’ perspectives on the trade-off between the risk of endorsing an ineffective therapy (type I statistical errors) and the risk of rejecting an effective treatment (type II statistical errors).

Clinical trials designed and sized with consideration of patient preference information may expedite trials and elevate the voices of smaller patient populations and patients with rare diseases. By creating clinical trials that reflect patients’ urgency and risk tolerance, scarce resources are allocated more efficiently, bringing more innovative therapies to more patients faster.