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. 2024 Apr 4:10:e47241.
doi: 10.2196/47241.

Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study

Sophia Themistocleous  1 , Christos D Argyropoulos  1 , Paris Vogazianos  2 , George Shiamakkides  1 , Evgenia Noula  1 , Andria Nearchou  1 , Andreas Yiallouris  1 , Charalampos Filippou  1 , Fiona A Stewart  3   4 , Markela Koniordou  5 , Ioannis Kopsidas  5 , Helena H Askling  6   7 , Sirkka Vene  6   7 , Amandine Gagneux-Brunon  8   9 , Jana Baranda Prellezo  10 , Elena Álvarez-Barco  11 , Jon Salmanton-García  3   4 , Janina Leckler  3   4 , Alan J Macken  11 , Ruth Joanna Davis  12 , Anna Maria Azzini  12 , Charis Armeftis  1 , Margot Hellemans  13 , Romina Di Marzo  14 , Catarina Luis  14 , Ole F Olesen  14 , Olena Valdenmaiier  15 , Stine Finne Jakobsen  15 , Pontus Nauclér  6   7 , Odile Launay  16 , Patrick Mallon  11 , Jordi Ochando  10 , Pierre van Damme  13 , Evelina Tacconelli  12 , Theoklis Zaoutis  5 , Oliver A Cornely  3   4   17   18   19 , Zoi Dorothea Pana  1
Affiliations

Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study

Sophia Themistocleous et al. JMIR Public Health Surveill. .

Abstract

Background: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research.

Objective: The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials.

Methods: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry.

Results: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were "positive" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being "very positive." Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries.

Conclusions: Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies.

Keywords: COVID-19; VACCELERATE; clinical trial; clinical trials; health advocate; health promotion; healthcare; patient advocacy groups; public health; vaccine trial; vaccines; volunteer registry.

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Conflict of interest statement

Conflicts of Interest: PM has received honoraria or research funding to his institution from Gilead Sciences, ViiV Healthcare, MSD, and AstraZeneca. OAC reports grants or contracts from BMBF, Cidara, EU-DG RTD (101037867), F2G, Gilead, MedPace, MSD, Mundipharma, Octapharma, Pfizer, and Scynexis; consulting fees from AbbVie, AiCuris, Biocon, Cidara, Gilead, IQVIA, Janssen, Matinas, MedPace, Menarini, Moderna, Molecular Partners, MSG-ERC, Noxxon, Octapharma, Pfizer, PSI, Scynexis, and Seres; honoraria for lectures from Abbott, AbbVie, Al-Jazeera Pharmaceuticals/Hikma, Gilead, Grupo Biotoscana/United Medical/Knight, MedScape, MedUpdate, Merck/MSD, Noscendo, Pfizer, Shionogi, and streamedup!; payment for expert testimony from Cidara; participation on a Data Safety Monitoring Board or Advisory Board for Boston Strategic Partners, Cidara, IQVIA, Janssen, MedPace, PSI, Pulmocide, Shionogi, and The Prime Meridian Group; a patent at the German Patent and Trade Mark Office (DE 10 2021 113 007.7); stocks from CoRe Consulting and EasyRadiology; and other interests from Wiley. The other authors declare that they have no known competing financial interests nor personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
Illustration created using MapChart indicating the responses based on the residence country of the respondents (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) for the VACCELERATE patient advocacy groups (PAGs) survey; although all the respondents’ nationalities belonged to the 10 European countries where the online anonymous questionnaire was circulated, registered responses from other countries resulted from differing countries of residence (created with MapChart [19], which is published under Creative Commons Attribution-ShareAlike 4.0 International License [20]).
See this image and copyright information in PMC

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