Journals aim at recruitment & data in trial transparency push

By Nick Taylor

- Last updated on GMT

Related tags Food and drug administration Clinicaltrials.gov

Journals aim at recruitment & data in trial transparency push
Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.

Articles published in BMJ ​and PLoS Medicine ​call for greater transparency in clinical trials through increased sharing of information. The BMJ editorial​ accompanies a cluster of research papers that show, despite regulatory pressure, many clinical trials fail to report data in a timely manner.

This is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems​”, Richard Lehman, of University of Oxford, and Elizabeth Loder, of BMJ​, wrote.

In 2007 the US Food and Drug Administration (FDA) Amendments Act made publication of summary results on ClinicalTrials.gov mandatory within one year. An analysis of ClinicalTrials.gov​ published by BMJ ​yesterday found 40 per cent of industry funded trials had reported results.

The BMJ ​editorial calls for stronger enforcement to encourage data reporting. “Concealment of data should be regarded as the serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organisations​”, Lehman and Loder wrote.

Recruitment reporting

A paper in PLoS Medicine​tackles transparency earlier in the process by calling for all investigators’ patient recruitment targets to be published on ClinicalTrials.gov before a study begins.

The authors of the paper, who include a former GlaxoSmithKline employee and an advisor to the Spanish Medicines Agency, also want information on issues that could affect recruitment to be shared.

We propose for a given site, that if the trial has more than one recruiting principal investigator, then information for all recruiting investigators should be provided​”, the authors wrote. Access to this data could help sponsors “recruit investigators with a track record of fulfilling their commitments​”.

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Related suppliers

Follow us

Products

View more

Webinars