As the pandemic wanes, a new report shows that most sponsors and CROs plan to continue using the clinical trial innovations postpandemic, and that fears of a “snap back” to the status quo are misplaced. But the survey also found that sponsors and CROs have very different views on how prepared they are to deploy certain innovations for the long haul. 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
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
Accelerated timelines for clinical trial startup will become more the norm postpandemic, but different types of trials will find success at speed at different kinds of sites. 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
