Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...
An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.
The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
TrialScope this year awarded several companies for their clinical trial data transparency efforts as the industry makes strides to engage patients and the larger health care community.
The Pistoia Alliance hopes to facilitate “seamless data integration” between various industry stakeholders, including life sciences companies and CROs, via an open and freely available data format.
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.
By Melanie Brickman Borchard, PhD, MSc, director of life sciences, New York Academy of Sciences
Increased access to real-world data sources opens up new possibilities, but it also raises new ethical questions, which cannot be tackled by one organization, government agency, or company alone.
Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased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.
Undisclosed pharmaceutical industry payments to authors of oncology clinical trials published in scientific journals raise concern around credibility and trustworthiness, according to a recent report.
Pan-American countries should adopt EMA-style regulations to increase clinical trial transparency and streamline research, according to a recent report.
Pfizer, AbbVie, and GlaxoSmithKline are among the members of a clinical trial data-sharing and analytics platform designed to speed up the discovery and development of new treatments.
Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.
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.
Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.
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 EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
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.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
The Good Pharma Scorecard aims to quantify what makes a “good” pharmaceutical company – as 91% of Americans think companies put money before people, says Bioethics International founder.
A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.
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.
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
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 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 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.
US Senator Elizabeth Warren recently published a perspective calling for strengthening research through data sharing – but the perspective was not met without feedback.
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.
As the company tries to move out from under Shkreli's cloud, KaloBios has announced a new product pricing model that promises transparency, affordably, and reasonable return.
A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.
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?
