Tag Archives: Clinical Trials

European Regulator’s Last Ditch Attempt at Transparency

By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
Posted in Europe, Global, Op-Ed, Regulatory | Also tagged , , , | Leave a comment

After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
Posted in Biotech, Corporate Responsibility, Europe, FDA, Global, IP, leadership, Legal, R&D, Strategy, Technology | Also tagged , , , , , , , , | Leave a comment

Clinical Trials in the Digital Age

In 1995, there were 16 million internet users — or 0.4% of the world’s population. In just 17 years, this figure has grown to 2.4 billion and 34.3% adoption. At the current rate, each year, the penetration percentage sees a 2–4% growth. Many services, such as banking, have moved towards online service models, shutting down branch […]
Posted in R&D, social media, Technology | Also tagged , | Leave a comment

Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
Posted in FDA, Gene therapy, Regulatory, Safety | Also tagged , , , | Leave a comment

FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
Posted in FDA, Marketing, R&D, Regulatory, Strategy | Also tagged , , , | 1 Comment
  • Categories

  • Meta