Trial Design Articles

FDA Policies Support Shift to Decentralized Clinical Trials

Feb 08, 2019

By Jill Wechsler

FDA Commissioner Scott Gottlieb supports approaches that help biomedical research “become more agile and efficient” and reduce the cost of developing therapies, including decentralized trials and how real-world data (RWD) and real-world evidence (RWE) can support a range of drug development goals.

Complex, Puzzling, Ill-Defined: Challenges in Assessing PTSD

Oct 10, 2018

By Krista Armstrong

A recurring challenge in assessing and treating Post-Traumatic Stress Disorder or PTSD is the inherently complex, ill-defined, and sometimes downright puzzling nature of its symptoms.

Alzheimer’s Clinical Trials: Obstacles and Opportunities

Oct 09, 2018

By Krista Armstrong, Sebastian Turek

For sponsors who are pursuing the goal of treating Alzheimer’s disease, understanding the obstacles inherent in Alzheimer’s clinical trials can help in planning for, and overcoming, these challenges.

Mid-Sized CROs Consolidate in Specialized Therapeutic Areas

Sep 10, 2018

By Moe Alsumidaie

Columnist Moe Alsumidae speaks to key Synteract executives on their acquisition of a dermatology CRO to augment its own expertise and grow the specific services necessary for this therapeutic specialty.

Cancer Immunotherapy Biomarkers: Four Trends to Watch

May 29, 2018

By Nina Baluja, M.D.

Here are four trends to watch as researchers continue to make headway in the development of biomarkers for cancer immunotherapy.

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