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.
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The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased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.
