news roundup

Jamie Macdonald Appointed as the new CEO of PAREXEL

PAREXEL International Corporation announced the appointment of Jamie Macdonald as CEO effective March 15, 2018.

FDA Strives to Maintain Gains in Speeding More Breakthroughs to Patients

Now the challenge to FDA and to sponsors is to maintain the high level of support for research, discovery, and regulatory flexibility underpinning these gains, writes Jill Wechsler.

Communicating R&D: Pipers, Payments, and Persuasion

Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.

Making Real-World Evidence Real

An expert view on how sponsors can formalize the use of real-world data and generation of real-world evidence to drive critical insights.

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Articles

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.

Patient Engagement: Are We There Yet?

Findings from a new ACT and SCORR Marketing survey reveal a gap in the shift to true patient-engagement in clinical trials, but overall measures do signal growth in patient-centric activities.

Oncology

Rare Diseases and Concrete Cases

The rare disease community in Europe has come out fighting to defend its record—and its future—in the face of what it sees as growing threats to research.

Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com