1. Pink Sheet
  2. >>Geography
  3. >>Europe

New Guide Offers Practical Insight Into EU Clinical Trial Lay Summaries

 
• By Vibha Sharma

Sponsors are being urged to plan early and involve patients in every aspect of preparing the plain language summaries of clinical trial results that will become mandatory when the EU Clinical Trials Regulation starts applying from December 2021.

Clinical trials
Lay summaries will provide trial results in an easy to understand format • Source: Shutterstock

A draft industry guideline on preparing lay summaries of clinical trial results, which are mandated under the EU Clinical Trials Regulation, recommends early, careful and proactive planning by sponsors to ensure the timely delivery of high-quality and legally compliant plain language summaries.

The guideline on good lay summary practice (GLSP) – which is the result of a multi-stakeholder initiative being jointly led...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
• By Francesca Bruce

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

More from Geography

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
• By Francesca Bruce

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.