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Kenneth Getz is a senior research fellow at the Tufts Center for the Study of Drug Development.

Articles

Study uncovers pre-pandemic deviation levels.

Quantifying Protocol Deviation Experience by Clinical Phase

Addressing sources of tension on differentiating types of data.

Just How ‘Real’ is Real-World Data?

SVP, Clinical Pharmacology & Translational Medicine

Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.

With Project Optimus, Success Favors the Prepared

A look at the prevalence of placebo response in clinical trials and how advanced solutions can mitigate the risk it poses to drug development.

Using Machine Learning to Predict Placebo Response and Increase Clinical Trial Success

Implementing new strategies with the use of patient-reported outcomes.

Considering Patient Burden in Oncology 

Insights from studies on advisory boards and participation burden.

Amplifying Patient Voices in Protocol Design

Increased use of remote assets will showcase new endpoints derived from digital health technologies.

Utilizing DHTs for Clinical Trial Endpoints

Trials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.

How to Address—and Overcome—Operational Challenges in Master Protocol Studies

87% of people surveyed said they had no concerns about a decentralized approach to clinical trials. 

Recent Data Shows Positive Attitudes for Decentralized Trials in Rare Disease Patients

A novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.