Ethics/Regulatory

Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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Three Questions: Dr. Stella Blackburn, QuintilesIMS

Monday, November 28, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Dr. Stella Blackburn, vice president and global head of risk management for real-world evidence solutions at QuintilesIMS. As part of her efforts, Blackburn has been focused on the EMA’s adaptive pathways pilot program.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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