Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Calls for Greater Transparency in the Release of Clinical Trial Data

By The University of York | September 23, 2016

Researchers have called for greater transparency in the public release of clinical trial data after a study revealed significant under-reporting of side effects in medical treatments.

The study, led by the University of York, revealed that medical benefits are routinely reported, while side effects are incompletely documented in peer-reviewed journal articles.

The clinical benefits of new drugs are usually tested in randomized clinical trials, in which patients are randomly assigned to receive drug or placebo, before drugs can be prescribed widely.

Adverse events, or side effects, are also routinely collected in such trials, and should be reported in scientific journal articles to give a clear picture of the benefit and risks of new treatments.

The study, published in PLOS Medicine, found that 64 percent of side effects would have been missed by readers looking only at published reports about the medical treatments studied.

The authors conclude that full reporting of adverse events is essential to allow patients and doctors to assess the balance between benefits and side effects of medical treatments.

Dr. Su Golder, Research Fellow at the University of York’s Department of Health Sciences, said: “We need more transparency.

“People need to have access to full information about the harm from medical treatments, so that they are aware of the consequences of choosing a particular treatment.”

In one example, 198 deaths were recorded in clinical trials of four new drugs, and full details on the cause of death for all the participants were available from the pharmaceutical company dataset. In the subsequent published papers only 29 deaths were fully reported.

In another example, an unpublished report documented 15 suicides in drug treated participants, but only seven were revealed in published papers.

Golder added: “There are serious concerns that the published findings represent only a small snapshot of the full dataset, and that patients and healthcare professionals may be making decisions based on incomplete information.”

The study, which included collaboration with Gill Norman, University of Manchester, and Yoon Loke, University of East Anglia, was funded through the National Institute for Health Research (NIHR).

To view the full press release, click here.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news! 


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50