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).
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?
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 publicly register UK Phase I adult trials which began before September...
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.
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 original bill, and removed a section that would have required NIH grant recipients to share...
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.
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.
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 of Medicine.
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 of relevance to the public should be made publicly...
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
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.
Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference in Spain last week.
EMA tells us it looks forward to continuing close relationship with DG SANCO
DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
Drug developers should add their early-stage discoveries to an open-source database or pay a fine to cut wasted time duplicating results, say researchers.
Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
Transparency campaigners have called on the EMA (European Medicines Agency) to rethink regulations set to be approved on Thursday that they say will severely limit clinical trial openness.
SAS, a provider of tools for data and health analysis, will supply the platform for a project sharing oncology data from studies by AstraZeneca, Janssen R&D, Pfizer and Sanofi.
Roche has clashed with the authors of a report slamming the efficacy of Tamiflu, each claiming the other’s analysis of patient data is seriously flawed.
Tamiflu shortens the duration of influenza symptoms by only half a day, does not stop person-to-person spread and increases the risk of nausea say the authors of a new review who want Governments to rethink stockpiling neuraminidase inhibitors.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine.
In an exclusive Q&A, new ACRO Chairman Ciaran Murray says conducting trials in countries such as China and India is critically important for speeding up drug development.
Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.
Soon sponsors and CROs seeking ethical approval for clinical trials in the UK will have to register them in a public database under the HRA's transparency plan.
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.
The EU will become more competitive thanks to new clinical trial regulations that include data transparency, says rapporteur Glenis Willmott MEP, though industry is opposed.
US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground where micromanagement stays low and the level of quality remains high.
A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was...
Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal publishing codes.
In September Outsourcing-pharma held Patient Recruitment Outsourcing (PRO) in Boston, bringing together the movers and shakers in the recruitment sector. Robert Loll, vice president of business development, shares his thoughts on the event with a particular...
Senator Richard Moore has criticised transparency laws in Massachusetts, US, which he claims allow pharmaceutical companies to hide payments made to physicians conducting clinical trials.
