On 17 January 2016, a healthy man was declared brain-dead after receiving an experimental drug in a first-in-human trial in France. Four of five other subjects receiving the same dose have serious, ongoing neurological complications. Investigations into the trial described many troubling safety practices, such as steep increases in dose levels delivered to sequential subjects without sufficient delays to check for safety. In the wake of the tragedies, the French medicines safety agency (ANSM) ordered an examination of the information that the drug developer, Bial, based in Trofa, Portugal, had supplied to ethics committees and potential researchers before the trial. The report notes that the 63-page Investigator Brochure describing the trial included fewer than two pages of evidence that the drug had the desired pharmacological activity. It identified only two studies presented as evidence for efficacy, both problematic. A lack of emphasis on evidence for the efficacy of drug candidates is all too common in decisions about whether an experimental medicine can be tested in humans. There is a need to call for infrastructure, resources and better methods to rigorously evaluate the clinical promise of new interventions before testing them on humans for the first time, to ensure safety from bogus medicines.
- Global Top Players in Intraocular Lens (IOL) Market
- How Robots Are Introducing A New Dimension To Healthcare Service Delivery
- Analyzing the Most Promising Drugs That Will Lose Patent in the US & EU in 2022
- World Population Day 2018
- Which Countries Top the Chart in Global Pharmaceutical Market?
- How Healthcare Apps are Adding New Perspectives to the Healthcare Industry?
Clinical trials need to assess drug efficacy before trials
Feb 08, 2017 | Reading Time: < 1 minute
Where Women Healthcare Stands
Technology has made an impact on every field. And Healthcare is no exception. Advances in medical technology have proven to be a game-changer in the health sector. But is the case same when Women healthcare comes to mind? It will not be less than a shock to learn that Women were not included in medical research and...Find More
Cholera vaccine delivered; Rice-inspired breakthroughs; International partnerships
Cholera vaccine delivered through a cup of rice water Vaccinations against prevalent pathogens could be ingested as oral or inhaled as nasal vaccines, this is due to the development of non-invasive vaccines, which target the mucous membranes. These could help fight a plethora of infectious diseases such as cholera,...Find More
National health authorities, U.K.'s NICE determines Gilead's cancer cell therapy exorbitant The National Institute for Health and Care Excellence (NICE) found Gilead's cancer cell therapy, Yescarta to be clinically efficacious for treating a type of lymphoma, but no ample evidence is present to estimate the benefit...Find More
Sign Up & Stay Informed
Penetrative insights and rich analysis of Pharma, Biotech and MedTech space.Join Up Now!
Sign up For Newsletters
Hear from our subject-matter experts and in-house KOL’s on Pharma and Healthcare market trends.
ASCO Conference 2022
The American Society of Clinical Oncology is a platform that provides a global connection to researchers, pharma companies, and healthcare professions standing against cancer, finding a cure for it.