Article type
Abstract
Evidence-based medicine (EBM) has been integral to medical practice in China for the past 2 decades, helping clinical practitioners and policy-makers in optimizing medical decision-making.(1) Cochrane systematic reviews are widely recognized as the gold standard in systematic reviews due to their strict adherence to methodology and high level of trust among decision-makers.(2)
Regulatory Decision-Making Using Cochrane-Standard Systematic Reviews
The Chinese National Medical Products Administration has released several policy papers to guide the evaluation of drugs or medical instruments,(3-5) claiming that systematic reviews can be used in the evaluation work. Notably, the “Guidelines for clinical safety literature evaluation of marketed drugs”(3) specifies the use of Cochrane-standard systematic reviews to ensure the quality of the literature review and appraisal process. Following these policy guidelines, we assist the Center for Drug Evaluation in China (CDE) in various capacities, including evaluating new indications of specific drugs, postmarketing safety monitoring, and conditional approval of drugs. For instance, although mycophenolate mofetil (MMF) had been used globally for the treatment of lupus nephritis, it was not approved for this indication in China. Consequently, Chinese clinicians were hesitant to use it due to off-label use, resulting in many patients being unable to benefit from this treatment. To accelerate the approval process, the CDE proposed using Cochrane-standard systematic reviews to assess the effectiveness and safety of MMF for lupus nephritis. Our research team searched 10 electronic databases and gray literature. Two reviewers screened studies and extracted data. We recorded the data processing in CD-ROM, and any amendment on data could be tracked. Eighteen randomized controlled trials (RCTs) were finally included. Meta-analysis confirmed the superior treatment effect of MMF as induction therapy for lupus nephritis. This systematic review reduced the duration of patients' access to a new promising drug.
Facilitating Clinical Decision-Making With Cochrane-Standard Systematic Reviews
In 2021, the China Clinical Practice Guideline Alliance (GUIDANCE) was established as a significant advancement in evidence-based medicine.(6, 7) GUIDANCE aims to produce evidence-based guidelines by the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to optimize clinical decision-making. GUIDANCE also demands Cochrane-standard systematic reviews as the evidence base for their clinical guidelines.
Regulatory Decision-Making Using Cochrane-Standard Systematic Reviews
The Chinese National Medical Products Administration has released several policy papers to guide the evaluation of drugs or medical instruments,(3-5) claiming that systematic reviews can be used in the evaluation work. Notably, the “Guidelines for clinical safety literature evaluation of marketed drugs”(3) specifies the use of Cochrane-standard systematic reviews to ensure the quality of the literature review and appraisal process. Following these policy guidelines, we assist the Center for Drug Evaluation in China (CDE) in various capacities, including evaluating new indications of specific drugs, postmarketing safety monitoring, and conditional approval of drugs. For instance, although mycophenolate mofetil (MMF) had been used globally for the treatment of lupus nephritis, it was not approved for this indication in China. Consequently, Chinese clinicians were hesitant to use it due to off-label use, resulting in many patients being unable to benefit from this treatment. To accelerate the approval process, the CDE proposed using Cochrane-standard systematic reviews to assess the effectiveness and safety of MMF for lupus nephritis. Our research team searched 10 electronic databases and gray literature. Two reviewers screened studies and extracted data. We recorded the data processing in CD-ROM, and any amendment on data could be tracked. Eighteen randomized controlled trials (RCTs) were finally included. Meta-analysis confirmed the superior treatment effect of MMF as induction therapy for lupus nephritis. This systematic review reduced the duration of patients' access to a new promising drug.
Facilitating Clinical Decision-Making With Cochrane-Standard Systematic Reviews
In 2021, the China Clinical Practice Guideline Alliance (GUIDANCE) was established as a significant advancement in evidence-based medicine.(6, 7) GUIDANCE aims to produce evidence-based guidelines by the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to optimize clinical decision-making. GUIDANCE also demands Cochrane-standard systematic reviews as the evidence base for their clinical guidelines.