There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.
Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).
In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.
Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.
Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.
By 2020, orphan drug sales are expected to make up 19% of prescription drug sales, excluding generics.
Aspects of brain health include the way we think, feel, play, work, recall information and sleep. Exercise, healthy eating and positive social interactions are already known to improve these aspects of brain health, as are continually exercising the cognitive abilities of our brains.
The emergence of risk-based monitoring (RbM) is creating a revolution in the way biopharmaceutical sponsors and CROs manage clinical trial quality.
With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding.
As acceptance for risk-based monitoring grows, this e-Book examines next steps for sponsors and CROs. This e-Book offers case studies, practical tips, and applications to enhance the effectiveness of a risk-based monitoring strategy.
This e-Book features information from a recent conference of global thought-leaders in clinical data disclosure and transparency, which address current practices, potential challenges and solutions for pharmaceutical companies complying with the regulatory, ethical and legal issues around clinical trial data sharing.