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

pharmaphorum

Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. 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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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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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. For most of my adult life, I had been the typical American fat guy, gaining a pound or two a year and thinking little of it.

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Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Pharmaceutical Technology

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

Engineer 130
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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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