The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments. Read More

The market for clinical trial management system software is expected to be worth nearly $1.8 billion by 2019 with much of the double-digit growth taking place in developing countries, according to Persistence Market Research. Read More

Amid the push among House and Senate Republicans to pass a sweeping tax reform bill, clinical researchers called on the federal government to modernize the research and development tax credit. Read More

Employee turnover has spiked at contract research organizations internationally, but it remains steady in the U.S., according to HR+Survey Solutions. Read More

The FDA will issue grants of $1 million each to Duke University and the Institute for Advanced Clinical Trials for Children to promote pediatric clinical trials and trial-related research. Read More

Clinical trial sponsors are doing a better job of representing women in drug trials but still lag in representing racial minorities, according to FDA research. Read More

Apple plans to launch a massive clinical trial for the Apple Watch’s ability to detect a heart condition that kills 130,000 individuals every year. Read More

An Alzheimer’s research group offers positive news on clinical trials for Alzheimer’s drugs as well as suggestions for the way forward, in a new report. Read More

Because of delays in implementing the EU regulation, the UK’s compliance with future EU clinical trials rules will likely be subject to negotiation, as the country plans to only immediately implement EU regulations that were in place ahead of the planned March 2019 exit from the EU, according to a UK government official. Read More

Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI). Read More

The use of risk-based monitoring in clinical trials is expected to climb — with many sponsors planning to implement policies for the first time over the next two years — driven by the need to reduce oversight costs and mitigate risks. Read More