TranspariMED clinical trial transparency

4 Jun 2020

The FDA has failed to collect over $10 billion in fines from companies and universities for violations of a key clinical trial transparency law, data released today show.

According to the latest FDAAA Trials Tracker figures, 2,050 clinical trials are currently missing results on the world’s largest trial registry, ClinicalTrials.gov, which was set up to provide a comprehensive o...

3 Jun 2020

Over 40% of clinical trials of drugs currently being examined as possible treatments for COVID-19 have not made their results public, leaving important evidence gaps for the safety of drugs being repurposed for coronavirus patients, a study published today shows.

A team of researchers found that out of 3,754 completed trials involving 19 different drugs, 1,516 trials have made t...

2 Jun 2020

A study published today warns that getting a comprehensive overview of Covid-19 clinical trials is difficult due to flawed clinical trial registrations and weaknesses in the global trial registry infrastructure.

The 'living systematic review' by the Infectious Diseases Data Observatory (IDDO) analyses all Covid studies listed on trial registries as of early April 2020. It covers...

22 May 2020

German universities have uploaded the results of 76 clinical trials over the past six months. Universities have uploaded twice as many results over the past six months than during the preceding six years combined.

In December 2019, TranspariMED and BUKO Pharma-Kampagne released a report showing that German universities had a very weak track record in clinical trial publication.

I...

14 May 2020

A coalition of health groups has called on the European Medicines Agency to make public the full evidence on Covid-19 drugs as rapidly as possible.

In an open letter published today, four national Cochrane groups and IQWIG call for the publication of the Clinical Study Reports for all COVID-19 medicines and vaccines on the day a European marketing authorisation is issued....

12 May 2020

A new manual aims to assist universities across Europe in making their clinical trial results public.

It provides practical, step-by-step guidance on how to meet EU regulatory requirements and adopt WHO best practices, drawing on the experiences of successful universities in six European countries.

NOTE: Hyperlinks did not work In the version of the manual that was originally up...

11 May 2020

Evidence gaps on drugs are undermining the ability of scientists to identify potential treatments for COVID-19, scientists warn.

A review of clinical trials for favipiravir, a drug that may hold promise as a COVID-19 treatment, found that 12 out of the 14 trials completed worldwide do not have results available on trial registries.

These trials tested favipiravir for other indica...

Over 1,200 clinical trials worldwide have ground to a halt due to the impact of the COVID-19 pandemic, a new analysis of data on the American trial registry shows. Overall, the number of trials that are being terminated, suspended or withdrawn has more than doubled since the onset of the pandemic.

The data confirms widespread fears that even as new COVID-19 trials are bein...

24 Apr 2020

Over 500 clinical trials of potential COVID-19 treatments and interventions have been launched worldwide.

Here's a quick guide to getting data on who is researching what, where and when - and what they have discovered.

A more comprehensive overview is available for download below.

COVID-evidence now launched 

A living database of trials on interventions for COVID-19 focusing on agg...

24 Apr 2020

FDA secrecy surrounding falsification of data or violations in adverse event reporting detected during clinical trials is undermining the integrity of the scientific evidence base on drugs and medical devices, experts warn.

Writing in JAMA, they note that inspection reports compiled by the U.S. Food and Drug Administration are often kept from the medical research community,...

8 Apr 2020

Universities worldwide can now access a free software tool to improve their clinical trial reporting on the largest trial registry, the American ClinicalTrials.gov. 

According to a press release by TrialAssure, a specialist trial disclosure company:

"Academic institutions can sign up for a TrialAssure subscription specific to this program—at no cost— allowing users free acce...

5 Apr 2020

A data set released by the UK Health Research Authority provides a comprehensive overview of all 2,646 clinical trials that received ethics approval within the UK during the year 2019. The data offers meta researchers a unique opportunity to analyse an entire country’s clinical research activity.

In the UK, researchers must obtain ethics approval from one of the country’s region...

19 Mar 2020

A new project seeks to quantify research waste in the UK by checking whether 1,000 clinical trials have made their results public.

The project will examine interventional trials completed before 2016 that were run by twenty universities and NHS Trusts. It will focus on trials of medical devices and non-drug interventions, using manual searches to check whether they have made the...

In Denmark, sponsors that fail to report clinical trial results will soon face fines or even prison sentences, explains Lene Grejs Petersen of the Danish Medicines Agency in this guest blog.

The Danish medicines agency (DKMA) will further step up its efforts to improve the publication of results from clinical trials in Denmark.

In November 2019, DKMA published a statement highlig...

4 Mar 2020

The Medical Research Council has revealed details of how it monitors its grantees to ernsure that all clinical trials it funds are registered and report their results.

In doing so, the UK funding institution has essentially produced a detailed how-to manual that should be required reading for other medical research funders worldwide.

In 2017, major medical research funders from a...

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