VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment
Salmanton-Garcia J, Stewart FA, Heringer S, Koniordou M, Álvarez-Barco E, Argyropoulos CD, Themistolcleous SC, Valle-Simón P, Spivak O, Součková L, Merakou C, Mendonça MA, Davis RJ, Azzini AM, Askling HH, Vene S, Van Damme P, Steinbach A, Shiamakkides G, Seidel D, Olesen OF, Noula E, Macken A, Luís C, Leckler J, Launay O, Isitt C, Hellemans M, Frias-Iniesta J, Di Marzo R, Carcas AJ, Boustras G, Borobia AM, Barta I, Albus K, Akova M, Ochando J, Cohen-Kandli M, Cox RJ, Husa P, Jancoriene L, Mallon P, Marques L, Mellinghoff SC, Nauclér P, Tacconelli E, Beer-Tóth K, Zaoutis TE, Zeitlinger M, Cornely OA, Pana ZD and the VACCELERATE consortium.
Preprints with The Lancet, 2022 Jan, DOI: http://dx.doi.org/10.2139/ssrn.4016606 and SSRN: https://ssrn.com/abstract=4016606
Abstract
Background: The coronavirus disease 2019 (COVID-19) pandemic has demonstrated the key role that vaccines play against infectious diseases. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE’s Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. Methods Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry.
Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements.
Findings: As of January 2022, the questionnaire is available in 9 countries and 11 languages. Up to date, more than 35,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched 13,719 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months.
Interpretation: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 9 countries. To date, more than 13,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 6 additional countries.