Clinical trial transparency (CTT) has been a growing area of interest for regulators as well as researachers both within and outside the pharmaceutical research industry over the last few years. AstraZeneca Pharmaceuticals (AZ) has had a commitment to sharing the results of research that it has sponsored through publications, registration at public web sites (e.g., Clintrials.gov as well as it’s own site) and sharing individual patient data at the request of outside investigators. This poster will elucidate AZ’s process for responding to requests for individual patient data, including scientific review of requests, data sharing agreements, redaction of clinical study reports and de-identification of data. Experience with CTT requests will be shared via case studies.

Investigators may make requests for individual patient data via a data transparency portal (https://astrazenecagroup-dt.pharmacm.com/DT/Home). To make a request, one would need to register (contact information only), read the FAQ, and click on “New Request”. This brings up a standard form (hard copy available upon request) which requires entry of the following information:

• Title and contact information • Primary research team, institution and statistician* • Background and Rationale for request • Description of data requested • Research hypothesis • Study Design and Primary/Secondary Endpoints • Statistical Analysis Plan • Publication Plan • Research Funding • Conflicts of Interest • Comment field and the ability to include attachments (e.g., CV).

Detail on the above will be provided. The authors have been involved in many CTT requests over the last three years as members of a product support team. They include physicians, statisticians, information scientists and programmers who respond to requests in a cross-functional manner on the due diligence team defined above. Individual requests have involved from one to nine separate clinical studies and mostly have fallen to the product support team’s discretion due to the data preceding the advent of the SRB process (i.e., 2009). Areas of interest have included exploration of placebo effects, patient subgroups, meta-analyses of data across companies and products as well as alternative analyses of efficacy endpoints. We have found the vast majority of collaborations with outside investigators to be mutually beneficial to both parties and successful in the goal of advancing science through sharing of data.