Clinical Research Management Briefing – April 9, 2018

Sixty grant applications have been reevaluated after the National Institutes of Health (NIH) discovered violations of confidentiality during the review process.

Science, March 29

Phase 1 Trials: Therapy, Not Just Science

Better patient selection processes and cancer therapy outcomes support increased participation in phase 1 clinical trials.

Cancer Therapy Advisor, April 4

Regulatory

Cancer Researchers Push to Relax Rules for Clinical Trials

Later this month, the US Food and Drug Administration (FDA) will review eligibility criteria to reduce barriers for patients to participate in clinical trials.

Nature, April 3

Mandated Restructuring of Informed Consent Documents Could Help Guide Patient Decision-Making

New requirements in the revised Common Rule seek to change consent forms so they provide more simplified and concise information to patients participating in clinical trials.

Center Watch, April 2

Technology

Cambridge Analytica Controversy Must Spur Researchers to Update Data Ethics

Increased access to big data raises ethical questions about how it should be used by researchers.

Nature, March 27

The Government Wants to Free Your Health Data. Will That Unleash Innovation?

Improving access to patient data could lead to major scientific progress – only if patient records are secure and shareable.

STAT, March 29