TY - JOUR
T1 - Independence of clinical events committees
T2 - A consensus statement from clinical research organizations
AU - Spitzer, Ernest
AU - Fanaroff, Alexander C.
AU - Gibson, C. Michael
AU - Seltzer, Jonathan
AU - McFadden, Eugene
AU - Ali, Maria
AU - Wilson, Matthew
AU - Menon, Venu
AU - Mehran, Roxana
AU - Held, Claes
AU - Mahaffey, Kenneth W.
AU - Lopes, Renato D.
N1 - Publisher Copyright:
© 2022
PY - 2022/6
Y1 - 2022/6
N2 - Background: Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging. Methods: This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance. Results: An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial. Conclusions: This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC.
AB - Background: Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging. Methods: This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance. Results: An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial. Conclusions: This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC.
UR - http://www.scopus.com/inward/record.url?scp=85127518491&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2022.03.005
DO - 10.1016/j.ahj.2022.03.005
M3 - Article
C2 - 35296411
AN - SCOPUS:85127518491
SN - 0002-8703
VL - 248
SP - 120
EP - 129
JO - American Heart Journal
JF - American Heart Journal
ER -