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Table 2 Points to consider in collaborative projects between pharmaceutical industry, academia, and patient organisations for grant-funded collaborations

From: Clinical development innovation in rare diseases: lessons learned and best practices from the DevelopAKUre consortium

Patient organisations’ points to consider in collaboration with industry and academia
Need financial resources from funders to allow patient organisation to hire professional staff
Lead representative of patient organisation needs to be on the management committee of the clinical study programme
Regular (weekly) contact with the consortium is crucial
Patient organisation needs to meet regularly with its patients to make sure it understands their needs properly. Also, needs to carry out regular surveys to gather information on patient satisfaction
Patient organisation can be faster than other—such as medical institutions—at reimbursement of patient travel expenses, which otherwise can cause problems and increase patient drop-out due to administrative matters
Academia’s points to consider in collaboration with industry and patient organisations
Dialogue between academia and patient groups before, during and after the study programme enables projects
Close and real co-operative links between academia and patient groups empower partnership to make the maximum use of skills
Academia will not necessarily have the clinical study skills and a good relationship with the pharmaceutical partner is essential for success
In addition to contributing effectively to the scientific aspects of the project, pharmaceutical partners bring irreplaceable regulatory expertise needed for successful conclusion of the project
Recognition and devolution of activities better delivered by the most appropriate partner allows smooth project flow and less obstacles to successful completion
Pharmaceutical companies’ points to consider in collaboration with patient organisations and academia
Ensure adherence to international and national laws and regulations on industry engagement with patient organisations and healthcare professionals
Consider ethical aspects in patient recruitment and handling of privacy and security of any personal information when patient organisations are involved in recruitment activities
Understand and respect integrity, credibility and independence of the patient organisation and researchers
Understand and respect the patient organisations’ and researchers’ working environment and constraints
Transparently disclose cooperation
Ensure formalised contracting, with clear expectations and roles and responsibilities, prior to start of collaboration