Position Papers

The EFSPI/PSI regulatory committee commented on the ICMJE data sharing proposal, which would require authors to make available de-identified individual patient-level data (IPD) underlying clinical trial results included in a manuscript no later than 6 months after the release of the publication, and a data sharing plan to be included in registering a clinical trial.

To view the EFSPI/PSI comments Click Here.

	Benefit assessment in Germany: requirements & challenges presented for 6 topics
	Future roles and careers paths for statiscians
	Roles and career paths for statisticians in today’s Pharmaceutical Industry
	EFSPI comments on EMA's draft Policy 0070 on publication and access to clinical-trial data
	EFSPI Position Paper on Access to Clinical Trial Data
	The draft FDA guideline on non-inferiority clinical trials: a critical review from European Pharmaceutical Industry Statisticians
	Position Paper on JAMA editorial policy
	Position Paper on JAMA editorial policy (cover letter)
	Visions on the role of Statisticians in the Pharmaceutical Industry
	Choice of Control in Clinical Trials - Issues and Implications of ICH-E10
	Qualified Statisticians in the European Pharmaceutical Industry: Report of a EFSPI Working Group
	A European Concept for Good Statistical Practices in Global Drug Development: Report of a DIA/EFSPI workshop