TY - JOUR
T1 - Translational research in cardiovascular repair a call for a paradigm shift
AU - Chamuleau, Steven A. J.
AU - van der Naald, Mira
AU - Climent, Andreu M.
AU - Kraaijeveld, Adriaan O.
AU - Wever, Kim E.
AU - Duncker, Dirk J.
AU - Fernández-Avilés, Francisco
AU - Bolli, Roberto
PY - 2018/1/1
Y1 - 2018/1/1
N2 - The international consortium TACTICS (Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes) has recently addressed key priorities in the field of cell-based therapy for cardiac repair, identifying the efficacy of translational research as one of the main challenges to ultimately improve the quality of life of patients with ischemic disease. Much of the controversy and confusion surrounding cardiac regenerative therapy stems from insufficient rigor in the conduct of preclinical studies, and there is an increasing recognition of a number of problems that undermine its quality that may contribute to translational failure. Here, we introduce well defined stages for preclinical research, and put forth proposals that should promote more rigorous preclinical work, in an effort to improve its quality and translatability. To augment the utility of preclinical research and its translation, it is necessary to (1) improve the quality of preclinical research, (2) promote collaborative efforts, and (3) enhance the sharing of knowledge and protocols. In particular, confirmatory (stage III) preclinical studies should be considered as a preamble to clinical studies and therefore must adhere to their standards of quality (including internal validity, standardization of protocols, and multicenter design). To increase transparency and minimize bias, these studies should be prospectively registered in an independent, open database. Ultimately, these recommendations should be implemented in the daily routine of investigators and in the policies of institutions, journals, and funding agencies.
AB - The international consortium TACTICS (Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes) has recently addressed key priorities in the field of cell-based therapy for cardiac repair, identifying the efficacy of translational research as one of the main challenges to ultimately improve the quality of life of patients with ischemic disease. Much of the controversy and confusion surrounding cardiac regenerative therapy stems from insufficient rigor in the conduct of preclinical studies, and there is an increasing recognition of a number of problems that undermine its quality that may contribute to translational failure. Here, we introduce well defined stages for preclinical research, and put forth proposals that should promote more rigorous preclinical work, in an effort to improve its quality and translatability. To augment the utility of preclinical research and its translation, it is necessary to (1) improve the quality of preclinical research, (2) promote collaborative efforts, and (3) enhance the sharing of knowledge and protocols. In particular, confirmatory (stage III) preclinical studies should be considered as a preamble to clinical studies and therefore must adhere to their standards of quality (including internal validity, standardization of protocols, and multicenter design). To increase transparency and minimize bias, these studies should be prospectively registered in an independent, open database. Ultimately, these recommendations should be implemented in the daily routine of investigators and in the policies of institutions, journals, and funding agencies.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85046851665&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29348252
U2 - https://doi.org/10.1161/CIRCRESAHA.117.311565
DO - https://doi.org/10.1161/CIRCRESAHA.117.311565
M3 - Review article
C2 - 29348252
SN - 0009-7330
VL - 122
SP - 310
EP - 318
JO - Circulation Research
JF - Circulation Research
IS - 2
ER -