Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.
Genetic testing could potentially transform the way clinical trials are conducted – but for the patient, the role of the genetic counselor is a key component of this process.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recently established a new advisory council devoted to patient engagement.
