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

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

Despite the pandemic, clinical trial activity remained historically high in 2020, especially in oncology, according to a new report by IQVIA. Clinical trial starts increased 8 percent in 2020, an annual growth rate on par with those observed since 2017. Read More

The use of master protocols in the U.S. will likely increase and expand into more treatment areas now that the FDA has signaled support for the practice in a new final guidance for COVID-19 trials last week. Read More

Compensating clinical trial participants for their time, effort and risk is a practice commonly accepted by regulators and IRBs, although regulations do not specifically mention the concept. Instead, they require only that a trial’s informed consent process be free of any coercion or undue influence although many questions remain about what’s allowed and what isn’t. Read More

As the pace of nonCOVID-19 trials picks up, some contentious issues are arising in the negotiation of clinical trial agreements (CTAs), partly due to what sites were willing to agree to at the height of the pandemic when most CTAs focused on COVID vaccines or treatments. Read More

Delays to study startup caused by the pandemic have eased with institutional sites now saying they’ve been able to reduce time needed for the process from six months on average to two or three months. Read More

Clinical trials in all therapeutic areas are increasing in complexity, but oncology trials are outstripping the rest of the field due to enrollment challenges, protocol deviations and a burgeoning amount of data that are adding months to their timelines. Read More

For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More