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

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 
• By Eliza Slawther

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

More from Geography

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.

Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 
• By Eliza Slawther

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.