PHARMACEUTICAL RESEARCH IN SUPPORT OF EVIDENCE-BASED NEW DRUG EVALUATIONS

摘要

HOW PHARMACEUTICAL MANUFACTURERS COLLABORATE WITH PAYERS ON CLINICAL RESEARCH:When manufacturers consider partnering with payers for research, they first have to address some regulatory requirements and compliance issues, said Arlene Price, PharmD, Senior Liaison, Health Economics & Outcomes Research, Johnson & Johnson. One of the most important early steps is to agree on the outcomes measures that payers deem important. "One step we can take toward that goal is to have greater collaboration with health systems and health plans earlier in the process," said Dr. Price. "When developing phase 2 and 3 studies, we will often ask payers what will be meaningful outcomes measures for deciding on coverage post-launch, and whether our current study design addresses these concerns."