European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) COMMENTS ON DRAFT FDA “Guidance for Industry - Non-Inferiority Clinical Trials” Rapporteur:

The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians.

The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) engages more than 2000 statisticians through its ten national organizations. Amongst other things, EFSPI is involved in reviewing regulatory guidelines under development, including the draft FDA guideline on non-inferiority clinical trials. This review resulted in several critical comments relating to as follows: (i...

CHOICE OF CONTROL IN CLINICAL TRIALS - ISSUES AND IMPLICATIONS OF ICH-E10 On behalf of the European Federation of Statisticians in the Pharmaceutical Industry

The ICH-E10 guideline on the choice of control group in clinical trials was a long awaited document. The concept paper gave reason to hope that it would give clear and harmonised guidance to an area, which has been very much disputed, including the burning issue of the role of placebo control. In the main, the final guideline was disappointing in spite of the long preparation time. In many resp...

Statistical guidance for responsible data sharing: an overview

Since at least 2004 there has been a focus on data sharing and clinical trial disclosure with the requirements for protocols to be registered in clinicaltrials.gov and for subsequent manuscripts of the study results to be accepted for publication by major journals [1]. However, sponsors of clinical trials have for many years been widely criticised for not adhering to these requirements and fail...

Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry

Development of guidance for statistical analysis plans (SAPs) for clinical trials

Methods The project included: identification of existing SAP guidance; identifying and reviewing published SAPs; a survey of current practice within UKCRC registered Clinical Trial Units (rCTU) and a Delphi survey to establish consensus on SAP content. The Delphi survey included rCTU statisticians, CONSORT and SPIRIT guideline authors, experienced statisticians in the pharmaceutical industry, j...