In the era of big data, the industry is working to address the ethical concerns of integrating patient information into the health care landscape – though a key challenge will be reaching a consensus on what constitutes reliable evidence.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased transparency.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
GlaxoSmithKline has selected TrialScope to facilitate clinical trial disclosure and transparency – as the benefits of patient centricity are paramount, and the risks of poor compliance magnified, says VP.
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.
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 clinical trial participants.
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...
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...
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.