In clinical development,adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under investigation.The purpose is to ensure that there is an...In clinical development,adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under investigation.The purpose is to ensure that there is an accurate and reliable assessment of test treatment under study.In practice,however,some controversial issues inevitably appear despite the compliance of good clinical practice.These debatable issues include,but are not limited to,(1)appropriateness of hypotheses for clinical investigation,(2)feasibility of power calculation for sample size requirement,(3)integrity of randomisation/blinding,(4)strategy for clinical endpoint selection,(5)demonstrating effectiveness or ineffectiveness,(6)impact of protocol amendments and(7)independence of independent data monitoring committee.In this article,these controversial issues are discussed.The impact of these issues in evaluating the safety and efficacy of the test treatment under investigation is also assessed.Recommendations regarding possible resolutions to these issues are provided whenever possible.展开更多
1.Background For the past several decades,minimally invasive surgery(MIS)has been advantageous for the treatment of cervical cancer compared to open surgery.MIS is favored due to reduced blood loss,decreased postopera...1.Background For the past several decades,minimally invasive surgery(MIS)has been advantageous for the treatment of cervical cancer compared to open surgery.MIS is favored due to reduced blood loss,decreased postoperative complications,rapid recovery,and shorter hospitalization time.In 2018,results from the Laparoscopic Approach to Cervical Cancer(LACC)trial,an international multicenter randomized phase III trial of women with early-stage cervical cancer comparing the survival outcomes among different surgical approaches1 and a real-world study published in the New England Journal of Medicine.展开更多
文摘In clinical development,adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under investigation.The purpose is to ensure that there is an accurate and reliable assessment of test treatment under study.In practice,however,some controversial issues inevitably appear despite the compliance of good clinical practice.These debatable issues include,but are not limited to,(1)appropriateness of hypotheses for clinical investigation,(2)feasibility of power calculation for sample size requirement,(3)integrity of randomisation/blinding,(4)strategy for clinical endpoint selection,(5)demonstrating effectiveness or ineffectiveness,(6)impact of protocol amendments and(7)independence of independent data monitoring committee.In this article,these controversial issues are discussed.The impact of these issues in evaluating the safety and efficacy of the test treatment under investigation is also assessed.Recommendations regarding possible resolutions to these issues are provided whenever possible.
文摘1.Background For the past several decades,minimally invasive surgery(MIS)has been advantageous for the treatment of cervical cancer compared to open surgery.MIS is favored due to reduced blood loss,decreased postoperative complications,rapid recovery,and shorter hospitalization time.In 2018,results from the Laparoscopic Approach to Cervical Cancer(LACC)trial,an international multicenter randomized phase III trial of women with early-stage cervical cancer comparing the survival outcomes among different surgical approaches1 and a real-world study published in the New England Journal of Medicine.
