When the FDA threatened penalties in April against a sponsor for failure to submit timely trial results to ClinicalTrials.gov, many saw it as a shot across the bow warning sponsors of the agency’s intention to get tough on violators of a rule intended to make trials more transparent and research findings more accessible to the industry and the public alike. Read More
For more than a year, sponsors have been working with some form of decentralized trials (DCT) and are seeing more clearly how some protocols are benefitting — and some not — from specific elements of decentralization. Read More
The number of oncology trial starts hit a record high in 2020, rising 60 percentage points above the 2015 total, according to a new IQVIA report on global oncology R&D trends. Oncology and rare diseases are the two largest areas of the clinical trials ecosystem, the report points out, and both were less disrupted by the pandemic than other areas of research. Read More
The speed with which Pfizer was able to develop its COVID-19 vaccine with BioNTech can be replicated by other sponsors if they do things in parallel, determine how much risk they are willing to shoulder upfront and think of clinical trials as one large protocol rather than taking a traditional phased approach. Read More
Verily has enlisted Amy Abernethy, the FDA’s former principal deputy commissioner and acting chief information officer, as its next president of clinical research. Read More
