Practical considerations for collaborative research between the pharmaceutical industry and external investigators

Abstract

Traditionally, clinical research has been conducted via either industry sponsored studies or non-industry investigator sponsored studies. Collaborative Research provides a relatively new mechanism for industry and non-industry partners to work together in the pursuit of effective and safe treatments for the patient. The aims of this article are to provide both industry and non-industry investigators with a greater insight into the complex processes that are currently employed by industry when entering into Collaborative Research agreements, and to encourage consistency and transparency in approach across companies. In Collaborative Research, instead of being limited to providing funding and/or product, the industry partner contributes expertise complementary to that of 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 may be interventional, observational or preclinical. A collaboration requires appropriate process and governance frameworks to be established in order to be successful. Important considerations include the routes for submitting a request, the review and approval process, due diligence criteria, budgeting and contracting processes, permissible interactions during the execution of the research, the closing out of the research, and dispute resolution. It is also necessary to have in place an agreed communication strategy and a risk control framework. 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 other critical facets of Collaborative Research that are essential to avoid delays and disputes. With no global standards for Collaborative Research, it is important that partners establish practical procedures, good ongoing communication, alignment of goals, and transparent interactions and disclosure to jointly advance the science of new, safe and effective therapies.