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OP0303-PARE (2023)
MULTI-STAKEHOLDER CO-CREATION TO FACILITATE CLINICAL TRIAL RECRUITMENT - A FEASIBILITY STUDY
M. Silva1, N. Caeyers2
1Esperity, Patient Centrics, Brussels, Belgium
2ReumaNet vzw, ReumaNet, Zaventem, Belgium

 

Background Recruitment for clinical trials remains a hurdle, causing potential delays in bringing innovative treatments to patients. Furthermore, there is not much communication about clinical trials towards the patient population and the general population has a lot of misconceptions around clinical trials. Communication about clinical trials is also subjected to a strict regulatory framework, especially in Europe. The information that can be found online is often in English and difficult to understand for the lay public.

Objectives For this reason, a feasibility study has been performed to develop a clinical trial portal for Belgium that allows users to search for trials in a local and lay language, while offering the portal to patient organisations and hospitals to receive updates on newly initiated trials.

Methods During the feasibility study the following aspects have been analysed by organising multi-stakeholder workshops, involving patient representatives and patient organisations (20), hospitals (8), HCPs (14), industry and representatives (10) of the Belgian medicines agency:user expectations, technical considerations, legal restrictions, regulatory and compliance aspects. Based on the multi-stakeholder workshops, a prototype has been developed that has been tested via user validation workshops. For the field of rheumatology, ReumaNet has represented the RMD community.

Results The result of the feasibility study revealed that only 15% of patient organisations (out of 190) mention clinical trials on their website, out of 140 websites of hospitals, only 16% mention clinical trials, while 2% have a search engine to search for ongoing studies. All academic hospitals (7) had a section dedicated to trials on their website. There was a great interest from the patient community (over 20 PAG participants) and the HCP representatives. A legal analysis has also set a framework for compliant communication about clinical trials to the lay public as well as a GDPR framework to define privacy related aspects of the portal.The portal has been launched in September 2022 as a first version, an improved version with a PAG dashboard is launched in February 2023.

Conclusion Based on the feasibility study, a clear need was identified to further develop the clinical trial portal in co-creation with the various stakeholders.

REFERENCES:

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Acknowledgements: NIL.

Disclosure of Interests Mitchell Silva Speakers bureau: Paid as a speaker in various pharmaceutical companies to give presentations about patient engagement. These include: AstraZeneca, Boehringer Ingelheim, Roche and MSD., Consultant of: Paid as a consultant to provide input on patient engagement strategy for various companies, including Roche, AstraZeneca, MSD, Janssen, GSK, Takeda, Boehringer Ingelheim, Merck, Nele Caeyers: None declared.

Keywords: Clinical trials, Patient information and education

DOI: 10.1136/annrheumdis-2023-eular.5815


Citation: , volume 82, supplement 1, year 2023, page 196
Session: DATA MATTERS: keeping track of your health information (Oral Presentations)