The clinical research business is approaching an inflection point similar to the shifts seen over the past 25 to 30 years, only now the trends are toward consolidation in larger health systems and their affiliates that can take a more patient-centric approach, according to Ken Getz, director of sponsored research programs at the Tufts University Center for the Study of Drug Development. Read More

The revised Common Rule, scheduled to take effect July 19, includes new requirements for the structure of informed consent documents, including that they begin with a concise presentation of the form’s essential points — a change that could turn the form into a tool that can help guide a patient’s clinical decision-making. Read More

Well-performed, confident site feasibility studies, at times a tedious, thankless task, can become the single most important factor in reducing costs and time spent during a clinical trial, according to Wes Martz, associate director of ePharmaSolutions’ clinical services division. Read More

The FDA previewed an upcoming pilot project that offers sponsors initial reviews of protocols for clinical trials with highly complex, innovative designs — including adaptive studies, master protocols and basket trials, as well as those using Bayesian statistics or computer simulations to determine operations. Read More

The FDA published its first batch of clinical data summary documents under a transparency pilot program launched earlier this year. Read More

Pediatric antibacterial drug trials currently account for less than one percent of all interventional and observational pediatric studies registered on ClinicalTrials.gov between October 2007 and September 2015, or only 82 out of 12,703. Read More

Experts convened at the National Academies of Sciences, Engineering and Medicine to examine how the uptake of real-world evidence will impact medical product development, recommending producers and consumers of evidence focus on maintaining transparency, accountability and reproducibility of results. Read More

The FDAAA TrialsTracker, an online tool that charts whether individual sponsors report their study results on ClinicalTrials.gov in compliance with federal laws and regulations, launched Feb. 19. The data transparency project was developed by the University of Oxford’s Evidence-Based Medicine DataLab, and is available to the public. Read More

Experts came together to speak at a WCG Rare Disease Day webinar on the main scientific and ethical considerations of research in rare and ultra-rare diseases, the majority of which are driven by hereditary genetic mutations. Read More

The first two randomized controlled trials of treatments of chronic medical conditions are much more likely to overstate any beneficial effects when compared to later clinical research, according to a group led by researchers from the Mayo Clinic, which urged regulators to be wary of data from early studies in a product’s chain of evidence. Read More