Simplifying Global Compliance
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December 2017
Vol. 22
No. 12
Headlines
Full Issue of Clinical Trials Advisor in PDF Format
Download and view the full issue. Read More
Biologics Manufacturers Need More Adaptable, Modular Strategies: Tufts Study
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
FDA Proposes Collaborative Approach for Pediatric Rare Disease Research
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies. Read More
Apple, Stanford Plan Huge Clinical Trial of Apple Watch for Atrial Fibrillation
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
Trials Improve on Gender, Age Inclusion, But Racial Participation Needs Work
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
FDA Awards $2 Million for Pediatric Clinical Trial Design
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
China FDA Releases Guidance on Foreign Clinical Data for Devices
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews. Read More
FDA Invites Comments on Clinical Data Template
The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Read More
FDA to Require Agency-Wide Training in Use of Patient-Reported Outcomes
A new requirement has been added to the FDA’s Reviewer Certification Program — training in the development, evaluation and use of patient-reported health outcomes, the agency said in its first report on PROs in medical device premarket submissions and post-market studies. Read More
FDA Updates Investigational Device Guidance
The FDA issued final guidance explaining the new framework the agency will use when assigning IDE devices to one of two categories prior to clinical studies — Category A: Experimental and Category B: Nonexperimental/investigational. Read More
CRO Staff Turnover Spikes as More Clinical Trials Are Registered Overseas
Employee turnover has spiked at contract research organizations internationally, but it remains steady in the U.S., according to HR+Survey Solutions. Read More
ACRO Calls on Congress to Modernize R&D Tax Credit to Recognize CROs
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
FDA Releases Guidances on Dual 510(k)-CLIA Waiver Submissions
The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation. Read More
Clinical Trial Management Systems Will Be $1.8 Billion Business by 2019: Report
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
EMA and EUnetHTA Publish Joint Work Plan
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More
EMA Expands Safety Guidance for Developing Anticancer Drugs
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Read More
EMA Adopts Guideline on Developing Treatments for Autism
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Read More
FDA Finalizes Guidance on Evaluating Drug Effects on Driving Ability
The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle. The agency recommends a tiered approach to evaluating drug effects, consisting of pharmacology/toxicology, epidemiology and clinical behavioral assessments. Data obtained early in development can be used to guide the collection of subsequent data related to driving impairment, for a better allocation of sponsor resources. Read More