Pharmaceutical Industry News Roundup: October 2019

by Staff Writer

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection from last month:

Researchers find 15% of trials could be replicated using real world data—Regulatory Focus

A recent study published in JAMA Network Open claims that currently-available real-world data sources can be used to replicate 15% of clinical trials. The researchers reviewed 220 clinical trials to see if the real-world data could be used to replicate the studies.

Michael Mezher has the full story

Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts U.S. FDA

The FDA issued draft guidance outlining future requirements of the electronic submission of certain safety reports. This will apply to products being evaluated by the FDA under an investigational new drug (IND) application into the FDA’s Adverse Event Reporting System (FAERS).

Visit the FDA newsroom for all the latest updates

How to ensure that novel analytic methods are fit for decision-makingEMA

In a recent article published in Clinical Pharmacology & Therapeutics, regulators and academics discuss how proper methodological validation ensures data credibility. This issues becomes increasingly important as new data sources, such as real-world evidence, become more available.

Visit the EMA website for more news

FDA offers methods, research practices for patient input in drug development—CenterWatch

The FDA recently issued guidance detailing how the industry should ask patients specific information about disease management and experience. This guidance is aimed at improved drug development with patient and caregiver input.

Read James Miessler’s piece in CenterWatch

Real world data playing a bigger role in drug development —MedPage Today

The increased use of electronic health records has improved the availability of health data. Changes in data collection can revolutionize the use of real-world data in drug approvals, according to Janet Woodcock, the longtime director of the FDA’s Center for Drug Evaluation and Research.

Read the article by Joyce Frieden

New FDA model aims to speed more rare disease treatments to patientsApplied Clinical Trials

Because rare diseases are difficult to study, the FDA has developed the Rare Disease Cures Accelerator initiative within the Center for Drug Evaluation and Research. The goal of this initiative is to use more coordinated research methods.

Jill Wechsler has the details  


MMS teams with Oracle for database buildOutsourcing Pharma

MMS Holdings recently worked with Oracle Health Sciences to build a complex database for an oncology pharmaceutical company. The build required several last-minute changes to the structure and involved multiple rounds of user acceptance testing (UAT).

Melissa Fassbender has the story  

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