TY - JOUR
T1 - Are randomized controlled trials being conducted with the right justification?
AU - Walters, Corbin
AU - Torgerson, Trevor
AU - Fladie, Ian
AU - Clifton, Angela
AU - Meyer, Chase
AU - Vassar, Matt
PY - 2020/8/1
Y1 - 2020/8/1
N2 - Objective: It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to combat research waste is to conduct randomized clinical trials (RCTs) only when a systematic review (SR) suggests more data are needed or when no previous SRs are identified. Here, we analyzed RCTs to determine whether SRs were cited as justification for conducting a trial. Methods: We analyzed phase III RCTs published between 2016 and 2018 in New England Journal of Medicine, Lancet, and JAMA. We performed duplicate and independent data extraction to ensure the accuracy and validity of our data. For each trial, we extracted whether SRs were cited as justification for conducting the clinical trial. Results: We examined 637 RCTs that cited 728 SRs. Overall, 38.1% (243/637) of RCTs cited an SR as either verbatim (6.9%, 44/637) or inferred (31.2%, 199/637) for trial justification. The 79 remaining RCTs cited SRs in other ways. Approximately, 49.5% (315/637) of RCTs did not cite a SR. Conclusions: Less than half of the analyzed clinical trials cited a SRs as the basis for undertaking the trial. We believe trialists should be required to present relevant SRs to an ethics or peer review committee demonstrating an unmet need prior to initiating a trial. Eliminating research waste is both a scientific and ethical responsibility.
AB - Objective: It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to combat research waste is to conduct randomized clinical trials (RCTs) only when a systematic review (SR) suggests more data are needed or when no previous SRs are identified. Here, we analyzed RCTs to determine whether SRs were cited as justification for conducting a trial. Methods: We analyzed phase III RCTs published between 2016 and 2018 in New England Journal of Medicine, Lancet, and JAMA. We performed duplicate and independent data extraction to ensure the accuracy and validity of our data. For each trial, we extracted whether SRs were cited as justification for conducting the clinical trial. Results: We examined 637 RCTs that cited 728 SRs. Overall, 38.1% (243/637) of RCTs cited an SR as either verbatim (6.9%, 44/637) or inferred (31.2%, 199/637) for trial justification. The 79 remaining RCTs cited SRs in other ways. Approximately, 49.5% (315/637) of RCTs did not cite a SR. Conclusions: Less than half of the analyzed clinical trials cited a SRs as the basis for undertaking the trial. We believe trialists should be required to present relevant SRs to an ethics or peer review committee demonstrating an unmet need prior to initiating a trial. Eliminating research waste is both a scientific and ethical responsibility.
KW - evidence-based medicine
KW - meta-analysis
KW - randomized control trial
KW - systematic review
UR - http://www.scopus.com/inward/record.url?scp=85087309231&partnerID=8YFLogxK
U2 - 10.1111/jebm.12405
DO - 10.1111/jebm.12405
M3 - Comment/debate
C2 - 32615030
AN - SCOPUS:85087309231
VL - 13
SP - 181
EP - 182
JO - Journal of Evidence-Based Medicine
JF - Journal of Evidence-Based Medicine
SN - 1756-5383
IS - 3
ER -