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Transparency on trial

Transparency on trial

Drug developers are under unprecedented pressure to make public the results of all clinical trials. Regulators worldwide are struggling to ensure they make this information available in a way that protects patients

TrialScope solution reduces clinical trial disclosure non-compliance risks, costs

13-Apr-2017 - ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.

The challenges and benefits of financial transparency in clinical trials

10-Nov-2016 - The push for transparency in clinical trials continues as the industry takes a closer look at its finances.

Guideline created for 'transparent and complete' clinical trial reporting

24-Oct-2016 - Researchers have developed a new international guideline to help standardize how clinical trial study results are reported.

Companies respond to EMA's efforts to release clinical trial data

10-Oct-2016 - The EMA recently appealed  two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.

The final rule: trial data to be made public in a 'change of business as usual'

22-Sep-2016 - The Obama administration recently finalized new rules that require researchers to make trial data public as the industry grapples with evolving data standards and looks to uphold its pledge to...

US Senator calls for clinical trial data sharing, consortium responds

08-Aug-2016 - US Senator Elizabeth Warren recently published a perspective calling for strengthening research through data sharing – but the perspective was not met without feedback.

Comparing and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to; however it’s not clear if these posts are complete and accurate.

Bitcoin tech to improve clinical trial research transparency

16-May-2016 - In an effort to improve transparency in clinical trial research, two doctors created a system that coverts trial documents into a Bitcoin – an online equivalent of cash.

AI solution redacts 'hundreds of studies per day,' Synchrogenix President

30-Mar-2016 - A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.

Tufts examines $2.87bn product lifecycle cost per approved drug

14-Mar-2016 - Tufts Center for the Study of Drug Development has released an assessment of the cost to develop and win marketing approval for a new drug.

'No single magic bullet' as drug pricing debate wages

01-Mar-2016 - The drug pricing debate continues as Hillary Clinton releases a new campaign video attacking Valeant - but how did we get here? 

Unpublished trial results: the 'blind spot' in the clinical research world

01-Mar-2016 - There are several reasons why clinical trial results are kept secret – some of more concern than others.


US plans to require trial consent publication

18-Nov-2015 - The US government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).

New regulation will drive EU clinical trials, but are you ready for it?

17-Nov-2015 - The new EU clinical trial regulation will overhaul the sector according to SynteractHCR, but are CROs prepared for the extra resources and tighter deadlines it will produce?

Trial Transparency

Positive RCTs drop to 8% under transparency regulations

06-Aug-2015 - Only eight percent of published clinical trials show positive drug results following new transparency standards, a sample study shows.


CRO vs HRA trial transparency case ends in a win for industry

29-Jul-2015 - A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to...

Funds worth €3.5tr back Alltrials, but none promise to pull cash from drug firms that don't

23-Jul-2015 - Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.

Revised 21st Century Cures bill takes a step back on NIH research transparency

07-Jul-2015 - With a House floor vote looming this week, legislators will decide on a revised bill that has decreased the amount of funding that will go to the NIH from the...

Trial data: charity hits back at CRO’s anti-transparency bid

25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.


EU trade secret proposals could help pharma avoid publishing trial results says NGO

16-Jun-2015 - Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.

WHO says anything short of full trial disclosure skews public spending

14-Apr-2015 - Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.

Study finds most US clinical trial data not publically available in a timely fashion

13-Mar-2015 - Despite legal reporting requirements, the vast majority of results from clinical trials are not reported on within a year of their ending, according to a new study from the New England Journal...

EUCROF calls on EMA not to publish CRO inspection reports as part of transparency efforts

11-Mar-2015 - The European CRO (contract research organization) Federation is calling on the EMA (European Medicines Agency) to not allow for the “unrestricted publication of inspection reports” as only “findings that are...

No GVK Bioscience trialled drugs under EMA spotlight are sold in Switzerland says Swissmedic

12-Feb-2015 - None of the drugs the EMA wants suspended over concerns about data manipulation at GVK Biosciences are sold in Switzerland says Swissmedic.

EMA defends Humira redactions, says only commercial info was blacked out

10-Feb-2015 - The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’

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