A non-systematic literature search was conducted using the MeSH terms: “Conflict of Interest” and “Patient Participation”, defined as patient involvement in the decision-making process in matters pertaining to health. When the term “Drug development” was added to the previous ones, the search rendered no results. Grey literature search was also used to identify documents and reports not accessible through the usual health/biomedicine bibliographic sources. Book references were also identified through this method.

An authoring group was defined within work package 4 (WP4) partners that was balanced in terms of stakeholder representation and expertise. Within the authoring group, a core group coordinated the writing of the deliverable with review cycles performed by a wider reviewer group. Efforts were made to include legal and compliance industry representatives, patient representatives with legal background and with personal experience on the topic of conflict of interest. Representatives from the European Medicines Agency also contributed to content development and document review.

• Guidance on what should be disclosed when filling in a required declaration of interest form before engaging with a given stakeholder. A standardized form or log to keep track of the different activities in which patients engage was suggested. This resulted in the development of the Log of patient engagement activities.
• Guidance to patients and engaging stakeholders on raising awareness on how to manage competing interests in a multi-stakeholder environment: This resulted in the development of the main guidance document and the short guidance.
• Practical examples on potential situations of competing interests and conflict of interest from the different stakeholder perspectives. This resulted in the development of the educational scenarios that were based on situational judgment tests.

To develop these tools, a multi-stakeholder authoring group with representatives from the above mentioned stakeholder groups was set up, with Task 4.2 partners acting as reviewers. Writing of the tool was led by leaders of the ‘managing competing interests sub-task’. Input from all authors was sought during dedicated editorial meetings. Draft versions were reviewed by Task 4.2 reviewers. In addition, a dedicated workshop breakout session held online in April 2020 focused on getting additional feedback. The documents underwent a second consultation with the PARADIGM consortium and the PILG and a public consultation.