Investigator’s brochures (IBs) are meant to be a living document, updated at least once a year to keep up with progress and developments in the trial. But scheduling and drafting updates can prove challenging, says Tiffany Guckin, associate director of…
CDER Drug Trials Report Shows Declining Enrolment
CDER released its fourth annual Drug Trials Snapshots report, which shows a significant drop in the number of participants in pivotal novel drug trials that led to agency approvals. The overall number of participants dropped by more than half from…
Doing More With Less: The Road To Success For Clinical Trials
Conducting a clinical trial can be both a time consuming and costly affair for pharmaceutical companies. If one is to be successful, they must have their affairs in order, from navigating protocols and regulations to the basic budgeting. As the…
Genentech Pulls Plug on Two Alzheimer’s Trials
Genentech has closed two large Phase III trials for its once-hyped anti-Alzheimer’s drug crenezumab after an independent data monitoring committee warned the company that crenezumab wasn’t likely to hit its primary endpoint. The CREAD 1 and CREAD 2 trials had…
Particle Sciences partners with Encube Ethicals to Develop Novel Vaginal Rings
Contract development and manufacturing organization (CDMO), Particle Sciences, a Lubrizol LifeSciences company, has announced its partnership with leading Indian contract manufacturing organization (CMO), Encube Ethicals. Under the partnership the two companies will develop innovative intravaginal rings with the intent to…
Investigators Most Likely to Be Cited for Failing to Follow Protocols, FDA Records Show
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…
