Community perception about participation as volunteers in Clinical Trials in Vaccines against SARS-CoV-2, Colombia.

Failure to recruit is the leading cause of discontinuation of clinical trials in the world, occurring in one in four studies. Given the cost of developing new technologies and the urgency of having safe and effective vaccines against SARS-CoV-2, it is expected to achieve the goals and overcome recruitment barriers (8) (9)

To date, three vaccine clinical trial programs are approved in the country by INVIMA (source https://www.invima.gov.co/estudios-clinicos-autorizados-para-covid-19) and at least three ECCAs are pending for approval.

Refusal of subjects to participate in vaccine clinical trials has been documented in various populations (7). Factors that may contribute include fear and distrust in vaccines, lack of knowledge about clinical trials, the epidemiology of the infection in the countries, and recently in Colombia the expectation of the start of the national vaccination plan may be a negative factor (6).

To date, there are few studies that evaluate the perception of participating in COVID-19 vaccine studies (6). This study hopes to identify possible factors affecting the decision to participate (barriers and motivations) in phase 3 COVID-19 vaccine studies, in the general population. The results obtained will allow us to propose strategies that strengthen and guide the recruitment processes.

Failure to recruit is the leading cause of discontinuation of clinical trials in the world, occurring in one in four studies. Given the cost of developing new technologies and the urgency of having safe and effective vaccines against SARS-CoV-2, it is expected to achieve the goals and overcome recruitment barriers (8) (9).

To date, three vaccine clinical trial programs are approved in the country by INVIMA (source https://www.invima.gov.co/estudios-clinicos-autorizados-para-covid-19) and at least three ECCAs are pending for approval.

Refusal of subjects to participate in vaccine clinical trials has been documented in various populations (7).

Factors that may contribute include fear and distrust in vaccines, lack of knowledge about clinical trials, the epidemiology of the infection in the countries, and recently in Colombia the expectation of the start of the national vaccination plan may be a negative factor (6).

To date, there are few studies that evaluate the perception of participating in COVID-19 vaccine studies (6). This study hopes to identify possible factors affecting the decision to participate (barriers and motivations) in phase 3 COVID-19 vaccine studies, in the general population. The results obtained will allow us to propose strategies that strengthen and guide the recruitment processes.

Clinical Trials; Vaccines; SARS CoV2; COVID 19.

Scientific article published in an indexed journal, quartiles 1 to 3.