Article by Guest Blogger Kathy Perez In this age of smart phones, cloud-based voice helpers and all things “Google” the public and medical profession have many ways to find a clinical trial. The most comprehensive listing of clinical trials in the world can be found at www.clinicaltrials.gov but when you Read more
Eligibility criteria exclude most ALS patients from clinical trials
According to a recent study, if the eligibility criteria of ALS targeted clinical trials were applied to a population of ALS patients in the Netherlands, nearly 60% of these patients would have been excluded from clinical studies. The authors recommend that we use a prediction model to select patients for clinical trials, rather than standard eligibility approaches. (ALS NEWS TODAY)
Trials exclude patients with mental or psychiatric disorders
According to the FDA, nearly 50% of investigational new drug applications excluded patients with mental or psychiatric disorders. Should cancer clinical trial eligibility regarding mental illness be relaxed? One viewpoint is that we should relax enrollment criteria and avoid unnecessary exclusion of patients with serious mental illness. (Healio)
National Cancer Institute expands eligibility criteria for trials
The National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions expand access for potential participants with preexisting conditions in 4 categories, and patients under the age of 18 years. (OncLive)
“Right to Try” disappoints ALS patients
In 2018, President Trump signed a federal Right to Try Act into law, allowing dying patients access to experimental treatments. Although there is an as-yet-unapproved treatment for Amyotrophic Lateral Sclerosis (ALS) currently in Phase 3 trials, ALS patients have to date not been able to access this treatment under Right to Try. (STATNews)
Only 10% of those harmed in clinical trials in India receive compensation
Since 2005, nearly 17,000 clinical drug trials were conducted in India. It is estimated that nearly 5,000 people lost their lives in clinical trials in India, and hundreds developed serious side effects, but only 10% of those affected received compensation. (Pharmafile)
Australia plans to implement GCP inspection program
Clinical trials in Australia are initiated based on approval of a Human Research Ethics Committee, not Australia’s Therapeutic Goods Administration (TGA), and TGA also lacks a routine inspection program to check whether clinical trials are complying with good clinical practice (GCP). TGA is now planning a GCP inspection pilot program as a stepping stone to a permanent, routine GCP inspection program. (Regulatory Focus)
China overhauling its clinical trial and drug processes
Clinical trial sponsors have long found a disconnect between the country’s potential and reality as a research location. Recently, however, Chinese authorities have been overhauling its clinical trial and drug processes, which now make it possible to get drugs approved in China using data generated overseas, and improved the process for sponsors that run trials in the country. (PMLIVE)
Veterans Administration mandated to conduct clinical trials on marijuana
House lawmakers introduced a bill last week that would mandate research into the potential therapeutic use of cannabis for conditions that commonly afflict veterans, such as chronic pain and post-traumatic stress disorder. While similar legislation filed during the last Congress said that the VA may conduct and support research relating to cannabis, this version stipulates that the VA “shall” carry out clinical trials on marijuana. (Marijuana Moment)
Freelance writer positions available
“Clinical Research Currents” is looking for individuals who would like to write clinical research-related articles for our newsletter and website. This could involve: identify the topic, conduct interviews, write up, and publish. We can help you by offering ideas for articles, or helping with interview questions, as you wish. Contact: Read more
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