“… charities can play a key role in representing the patient voice because they are in the unique position of having direct contact with patients while at the same time funding medical research.”
The National Institute for Health Research’s INVOLVE initiative explains more about public involvement in research and features some practical tools and resources for researchers and others on its website.
The ABPI is a member of an EU Commission project called PARADIGM, which is identifying the tools needed by both industry and patient and medical research charities to improve public and patient involvement in research and development.
PARADIGM is also working to develop metrics to evidence why public and patient involvement in research and development is beneficial.
EFPIA’s guide on Working Together with Patient Groups sets out how patient engagement across the lifecycle of a medicine, including at the R&D stage, can provide critical insights, for example in contributing to study design, informed consent forms and layperson summaries. It was developed by the EFPIA Patient Think-Tank (PTT) in collaboration with EFPIA’s Ethics and Compliance Committee, and provides helpful suggestions and solutions for some of the challenges.
What the ABPI Code says
Written agreements must be in place and companies must disclose details of the patient organisations to which they provide financial or significant non-financial support, under Clause 27 of the ABPI Code.
As with any activity, transparency is vital in building and supporting trust. Clause 13 of the ABPI Code covers clinical trials and non-interventional studies of marketed medicines and sets out the requirements for disclosure