Article type
Year
Abstract
Background: Recently the proliferation of scientific publications has led China to become the largest producer of scientific and clinical evidence. However, there are concerns over the redundancy of the research produced by Chinese scientists. Study is needed to evaluate the redundancy of clinical trials to save resource and protect patients.
Objectives: To estimate the number of extra major adverse cardiac events (MACEs) that occurred among patients with coronary artery disease (CAD) who were deprived of statins in redundant clinical trials conducted in Mainland China.
Methods: We searched PubMed, Embase, the Cochrane Controlled Register of Trials, and SinoMed until March 2020 for randomized or quasi-randomized trials conducted in Mainland China comparing statins with placebo or no treatment among patients with any subtype of CAD.
In the primary analysis, we defined trials as clinical practice guidelines (CPGs)-based redundant trials as those conducted after two CPGs were released explicitly recommending statins to patients with stable angina pectoris and acute coronary syndrome. The primary outcome was the number of extra clinical events, including MACEs, that were attributable to deprivation of statins in CPG-based redundant trials. The extra clinical events were the difference between the actual clinical events that occurred in the control groups and the expected clinical events if patients in the control group had received treatment as in the statins group.
In the sensitivity analysis, we defined trials as cumulative meta-analyses (CMAs)-based redundant trials as those conducted after CMAs illustrated that sufficient evidence had accrued to confirm the benefits of statins.
Results: After the CPGs were released, 1,864 and 91 redundant trials were initiated or continued recruiting, respectively. In total the CPG-based redundant trials recruited 197,296 patients, of which 96,481 were allocated to the control group and deprived of statins for 26,295 person-years. More than 4,484 extra clinical events were reported in 401 trials, including 3,367 MACEs and 1,117 other or unspecified events. The 3,367 MACEs consisted of 623 deaths, 939 cases of myocardial infarction, 201 cases of stroke, 113 cases of revascularization, 397 cases of heart failure, and 1,097 cases of relapsed or deteriorated angina pectoris.
The 2,302 CMA-based redundant trials reported more than 6,289 additional clinical events, including 4,745 MACEs and 1.544 other or unspecified events. The 4,745 MACEs consisted of 834 deaths, 1,355 cases of myocardial infarction, 256 cases of stroke, 208 cases of revascularization, 508 cases of heart failure, and 1,586 cases of relapsed or deteriorated angina pectoris.
Conclusions: Redundant and possibly unethical clinical trials conducted in Mainland China for statins among patients with CAD have resulted in numerous avoidable deaths and major cardiac events.
Patient or healthcare consumer involvement: None
Objectives: To estimate the number of extra major adverse cardiac events (MACEs) that occurred among patients with coronary artery disease (CAD) who were deprived of statins in redundant clinical trials conducted in Mainland China.
Methods: We searched PubMed, Embase, the Cochrane Controlled Register of Trials, and SinoMed until March 2020 for randomized or quasi-randomized trials conducted in Mainland China comparing statins with placebo or no treatment among patients with any subtype of CAD.
In the primary analysis, we defined trials as clinical practice guidelines (CPGs)-based redundant trials as those conducted after two CPGs were released explicitly recommending statins to patients with stable angina pectoris and acute coronary syndrome. The primary outcome was the number of extra clinical events, including MACEs, that were attributable to deprivation of statins in CPG-based redundant trials. The extra clinical events were the difference between the actual clinical events that occurred in the control groups and the expected clinical events if patients in the control group had received treatment as in the statins group.
In the sensitivity analysis, we defined trials as cumulative meta-analyses (CMAs)-based redundant trials as those conducted after CMAs illustrated that sufficient evidence had accrued to confirm the benefits of statins.
Results: After the CPGs were released, 1,864 and 91 redundant trials were initiated or continued recruiting, respectively. In total the CPG-based redundant trials recruited 197,296 patients, of which 96,481 were allocated to the control group and deprived of statins for 26,295 person-years. More than 4,484 extra clinical events were reported in 401 trials, including 3,367 MACEs and 1,117 other or unspecified events. The 3,367 MACEs consisted of 623 deaths, 939 cases of myocardial infarction, 201 cases of stroke, 113 cases of revascularization, 397 cases of heart failure, and 1,097 cases of relapsed or deteriorated angina pectoris.
The 2,302 CMA-based redundant trials reported more than 6,289 additional clinical events, including 4,745 MACEs and 1.544 other or unspecified events. The 4,745 MACEs consisted of 834 deaths, 1,355 cases of myocardial infarction, 256 cases of stroke, 208 cases of revascularization, 508 cases of heart failure, and 1,586 cases of relapsed or deteriorated angina pectoris.
Conclusions: Redundant and possibly unethical clinical trials conducted in Mainland China for statins among patients with CAD have resulted in numerous avoidable deaths and major cardiac events.
Patient or healthcare consumer involvement: None