Maureen Lloyd,1 Cynthia K Barbitsch,2 Mary Voehl Hirsch,3 Antonia Panayi,4 Eric Southam5

1LLOYDMJMC LLC, New York, NY, USA
2Pfizer Inc., New York, NY, USA
3Sanofi, Bridgewater, NJ, USA
4Shire (part of Takeda), Zug, Switzerland
5Oxford PharmaGenesis, Oxford, UK

The drive to seek novel therapies that are effective and safe for the patient has led the healthcare industry to turn to collaborations with external investigators to support research in innovative and cost-effective ways.

In Collaborative Research, as well as providing funding, the industry partner contributes expertise that is complementary to that of the non-industry partner, but it is the non-industry partner who is the sponsor of the study. Collaborative Research may be conducted before, during or after regulatory approval of a drug or medical device, and it may be interventional, observational or preclinical.

With no global standard on what Collaborative Research is, industry, non-industry and regulatory partners should recognize that they each face different challenges and that appropriate process and governance frameworks are required for a collaboration to be successful. Clear and specific contract language around roles and responsibilities, intellectual property, rights to data, registration and disclosure of publications, and an understanding of adverse-event-reporting procedures are also essential to avoid delays and disputes in Collaborative Research.

The aims of this article are to provide both industry and non-industry investigators with an insight into the complex processes that are currently employed by the industry when entering into Collaborative Research agreements and to encourage consistency and transparency in approach across companies.

Access to the published article (Lloyd M, Barbitsch CK, Voehl Hirsch, Panayi A and Southam E. Practical considerations for Collaborative Research between the pharmaceutical industry and external investigators. Policy & Medicine Compliance Update 2019;5:1–23) requires subscription, but a preprint of the article is available here: https://peerj.com/preprints/27785/.