As CSDD continues to watch industry efforts to bring innovations on board, Getz said the center hopes to eventually document case examples and best practices that successfully and sustainably speed up the process.
Sponsors, sites and academic institutions generally agree that the clinical trials industry needs formalized education programs and requirements for trial professionals, especially in light of a new survey that shows large competency gaps in several core areas.
Five months into his second go-round as FDA commissioner, Robert Califf once more stressed the importance of developing and employing a real-world evidence (RWE) system to support clinical research, especially for confirmatory trials of accelerated approvals.
Faced with an evolving clinical research and drug development landscape that was accelerated dramatically by COVID-19, the FDA’s Office of New Drugs (OND) will continue to take a progressive, adaptive approach to drug regulation going forward and explore innovative trial designs, according to its yearly report.
To improve trial diversity, sponsors should move away from eligibility criteria templates and draw up criteria specific to each trial, the FDA reminded industry last month.
The European Medicines Agency (EMA) is inviting sponsors to apply for participation in a pilot program that will assess the benefits of submitting and assessing “raw data” during reviews by the Committee for Medicinal Products for Human Use (CHMP).
