Principal investigators continue to have trouble following their own trial plans, an analysis of FDA inspection records shows. The FDA’s Bioresearch Monitoring Program (BIMO) cited 400 separate failures in fiscal 2018, of which nearly 30 percent — 118 instances —…
UK Regulators Back Away from Trials Location Requirement as Brexit Looms
UK regulators have backed away from a proposed post-Brexit requirement that drug sponsors have a point of contact in the UK to conduct clinical trials. The MHRA had floated a requirement that anyone sponsoring a trial in Britain or Northern…
FDA Guidance: Start with Kids in Atopic Dermatitis Trials
Sponsors of atopic dermatitis drugs for children don’t have to wait to test a drug’s safety or efficacy on adults before beginning pediatric trials, the FDA says. The new guidance, released last week, reverses longstanding FDA recommendations that drugs trying…
FDA Addresses Rare Disease Trial Challenges in Revised Draft Guidance
A new draft guidance on rare disease trials may help sponsors ease the tensions between the need for robust, scientifically sound data and the small patient populations that they’re hoping to treat. The guidance offers sponsors advice on filling the…
Centralized Monitoring in Practice — Lessons Learned from Early Implementers
A survey conducted recently by Metrics Champion Consortium shows most of the responding sponsors — 90 percent — indicate they are implementing ICH’s new centralized monitoring approach to risk management, but only about a third of that number say they…
CPhI report forecasts India to have strongest global growth in 2019
The India specific findings of the CPhI Annual Report highlight that India has seen significant jump across all (six) categories, improving its overall score by a massive 11.06% in a single year. The country showed the largest gains…
FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials
As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”…
Pharma R&D returns fall to lowest level in nine years
A new analysis that finds the soaring costs of clinical trials are eating away at return on R&D investments should serve as a wakeup call to the entire industry, a top executive says. Clinical trial professionals need to rethink the…
The power of digital tools to transform mental healthcare
The global burden of mental illness, both in terms of human suffering and economic loss, is catastrophic and rapidly growing. Worldwide, mental health conditions affect more than a third of the world’s population. Just two conditions alone – depression and…
Turnover Within CRO Companies Remains Persistently High, According to BDO Report
CHICAGO–(BUSINESS WIRE)–Clinical Research Outsourcing (CRO) companies are battling high turnover levels, but a new report from BDO USA, LLP, finds that compensation strategies generally have not made significant enough adjustments to their compensation strategy to address this issue. The 2018/2019…
