Top Nine Opportunities For Improving Observational Research

By Jeff Trotter, Executive Director, Phase IV Development

We recently received a Request for Proposal (RFP) from a large pharmaceutical company for an Observational Study to be conducted over the course of five years in several countries worldwide, involving hundreds of sites and thousands of patients. The RFP included a brief synopsis of the project and described how subjects would be randomized to one of two primary study arms in which they would be required to visit participating physician sites through a fixed schedule of follow-up visits. A detailed grid was included for us to complete seeking our proposed budget for, among other activities, a pre-determined number of monitoring visits.

RFPs like this are one of the primary reasons motivating us to develop and continue to deploy our Survey on Observational Research, now in its sixth iteration. Here are among the many issues underlying the RFP which seriously impact upon the chances for this study to actually be implemented