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Phases of Clinical Research: A Detailed Overview

Advarra

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Steps to building a more patient-centric industry

pharmaphorum

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Placebo Control

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

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