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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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Why Black People Remain Underrepresented in Clinical Trials

XTalks

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.

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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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Scepticism in press over Kintor’s COVID-19 US drug trial

pharmaphorum

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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Personalising whole genome sequencing doubles diagnosis of rare diseases 

Drug Discovery World

A new study led by Medical Research Council-funded researchers from UCL has found that tailoring the analysis of whole genome sequencing to individual patients could double the diagnostic rates of rare diseases. . It can also permit targeted screening of known disease complications and access to drug studies. Context .

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Fatty liver disease: With little early detection, more challenging drug development

pharmaphorum

That was until my doctors stunned me with the news that I had cirrhosis caused by non-alcoholic steatohepatitis, or NASH, a severe form of fatty liver disease that often has few or no symptoms until very late stages. Cirrhosis is not just an “old drunk guys” disease, a stigma which has long hampered interest and investment in research.

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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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