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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.
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.
A recent survey of clinical trial professionals found that more than two-thirds of respondents (61%) believe giving patients choice will have a positive impact on clinical research, and well over half (58%) said that their organisations plan to give patients the option to choose how they participate in clinical trials moving forward.
A major British medical school is leading the drive to eliminate what it calls “inherent racism” in the way doctors are trained in the UK. Exploring the fact that drugtrials predominantly involve white, male participants, and looking at how this may lead to inaccurate and harmful prescribing for other patients.
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.
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.
pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drugtrials. Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research.
And Black people continue to face generational disenfranchisement in healthcare systems and medical research. The overwhelming majority of trial participants nationwide are white. There are multiple barriers that prevent active trial participation. They are also at a high risk of developing heart disease and stroke.
Medical devices may be as complex as life-enhancing products implanted in patients or surgical assistance equipment, or items as simple as bandages, gloves, and other non-medication tools of a doctors trade, but as noted by one source , devices must go through various testing processes before they can be approved for patients.
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