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
10-Nov-2016 - The push for transparency in clinical trials continues as the industry takes a closer look at its finances.
24-Oct-2016 - Researchers have developed a new international guideline to help standardize how clinical trial study results are reported.
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.
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...
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.
20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.
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.
30-Mar-2016 - A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.
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.
01-Mar-2016 - The drug pricing debate continues as Hillary Clinton releases a new campaign video attacking Valeant - but how did we get here?
01-Mar-2016 - There are several reasons why clinical trial results are kept secret – some of more concern than others.
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).
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?
06-Aug-2015 - Only eight percent of published clinical trials show positive drug results following new transparency standards, a sample study shows.
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...
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.
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...
25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.
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.
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.
13-Mar-2015 - Despite legal reporting requirements, the vast majority of results from clinical trials are not reported on ClinicalTrials.gov within a year of their ending, according to a new study from the New England Journal...
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...
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.
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.’
16-Jan-2015 - The US Institute of Medicine has come out strongly in favour of sharing clinical trial results and says funding should be withheld from studies which do not make data public.