All best practices are gathered and driven by consensus from the entire consortium, comprised of over 20 patient advocacy groups and biopharmaceutical companies.
There has been, and remains, an ongoing and dramatic increase in the understanding and adoption of patient-informed medicines development collaborations between patient advocacy groups and industry. However, the increase in collaborations and number of entities initiating patient informed R&D efforts, has highlighted the range of disparities in approaches, variations in understanding of what can be done and a lack of consensus in how groups can work together more effectively. This is largely due to wide variation and inconsistency in collaboration expectations, processes, and practices confounded by a lack of consensus-driven expectations related to these topics (reference DiBiaso, Getz, et al).
The PALADIN Consortium assessed various areas whereby a common alignment on how to collaborate could save time, reuse, and better leverage resources already available. In doing so, the time saved could be applied to increasing the scope and effectiveness of such work.
The objective of this resource is to aggregate examples of best-in-class standards, templates, and recommendations for organizations to consider:
Note: the recommendations put forth in this section, largely represent the laws and compliance regulations in the US. There may be suggestions transversally adaptable to other countries, however, for the purposes of this document it is intended for US collaborations
Thank you for taking the time to read our newly launched playbook. This resource has been created to reduce the time that it takes to initiate, implement and evaluate collaborative efforts between patient organizations and industry. PALADIN will continue to add to this playbook and evaluate its utility as we strive to improve clinical trial participation and ultimately transform the pace of medicine’s development through stronger collaboration. We’d love to hear if you find this resource to be helpful.
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