Posts Tagged ‘clinical trials’

France issues stricter rules for pharma trials

lab_franceThe French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and hospitalized five others in January. France’s health minister Marisol Touraine presented a plan on Monday for stricter rules regarding human drug trials. The plan also requested the Rennes-based Biotrial CRO that conducted the trial to submit a “plan of action” within a month to explain how it will avoid a repeat of these or else lose its operating license.

The report, issued by France’s General Inspectorate of Social Affairs (IGAS), also calls on the government to “mobilize the international scientific community” to find out what went wrong and suggests a range of scientific approaches, such as testing whether the drug hits other brain targets than the intended one and a study of the potential toxicity of the compound’s metabolites. Read more…

One dead after Phase 1 drug trial in France

January 18, 2016 Leave a comment

er_testtubeA phase 1 drug trial is under scrutiny after one person has died and 5 others are in critical condition following ingestion of the drug. The private laboratory in France, Biotrial, has been testing a pain and mood disorder medication for Bial a Portuguese pharmaceutical company. The drug was a FAAH inhibitor and was supposed to act on the body’s pain, enocannabinoid, system. It had been tested on chimpanzees and just moved to the human phase earlier this month.

A multitude of media outlets have been reporting on the incident and additional details are becoming available to the public.  There are now reports of French prosecutors launching a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.
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New insurance template for Swiss clinical trials

October 2, 2015 Leave a comment

clinicalTrialsThe Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now requires the insured risk be categorized as category A, B, or C as outlined by Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) of September 20, 2013 (Status as of January 1, 2014). Insurers do not have the descriptions for the classifications, and are prohibited from providing advice regarding categorization of a trial. Sponsors or their CROs must seek advice from the Swiss Ethics Committees on research involving humans to determine the appropriate classification for their trial. Categorization of the trial is required before the certificate of insurance meets the requirements of the Human Research Act (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) can be issued. Certificates cannot be issued without the categorization of the Insured risk. Read more…

FDA officials warn drug makers: comply or face sanctions

indiadrugsHaving already faced serious legal threats from regulatory agencies last year, India’s pharmaceutical industry is now under additional scrutiny from the U.S.  Food and Drug Administration officials are intensifying investigations into the country’s drug facilities.  In February, this FDA Commissioner Margaret Hamburg met with Indian officials about the safety of Indian drug plants, following multiple reports that the country has sold fake pharmaceutical drugs and produced falsified drug test results.

India is currently the second largest exporter of over-the-counter prescription drugs to the U.S. and supplies 40 percent of generic prescription drugs to American consumers. The country exports about $15 billion in drug products each year and while many Indian manufacturing facilities are of top quality, others are in poor condition. The World Read more…

New trial regulations for medical device makers in South Korea

February 6, 2014 Leave a comment

sKoreaThe Ministry of Food and Drug Safety  (MFDS) will implement new clinical trial regulations for certain high risk medical devices looking to obtain trial approval. The agency announced last October that beginning in 2014, 68 devices (those that are either transplanted or absorbed into the human body) must submit trial data as part of technical documentation before receiving approval to conduct trials.

The MFDS, formally known as the Korea Food and Drug Administration, is a South Korean government agency that oversees the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics and supports the development of the food and pharma industries. Read more…

Computer simulators mean heightened standards for clinical drug trials

December 12, 2013 Leave a comment

drug simulatorRecent reports in the Wall Street Journal outline important developments in safety and efficacy standards for human clinical trials of drugs and devices. Drug companies are now using computer simulations in order to determine key clinical trial design features. Previously, issues like the length of trial were based on judgment and experience of the trial sponsor. With this new United Stated Food and Drug Administration and European Medicines Agency endorsed design protocol simulators, the bar has been raised for human testing.

Every time that regulators approve and endorse new technologies, they increase the standards for trial sponsors. In a case where a participant alleges harm from the trial, the absence of this capability may weaken the defense of any claims. So, drug and device Read more…

NIH cancels 40 clinical trials in India

August 12, 2013 Leave a comment

pills 2Six months after an apex court slammed Indian pharma MNC’s and researchers for failing to regulate the country’s drug trials environment, the National Institute of Health (NIH) has canceled 40 ongoing clinical trials in India. Despite the Health Ministry’s attempts to improve laws and procedures surrounding the trials, NIH (a branch of the US Department of Health and Human Services) called the regulatory environment still too unstable to continue.

Last January, India’s Supreme Court ordered that all clinical drug trials be performed under the Centre Health Secretary, after the apex court blamed the Health Ministry for neglecting to regulate illegal trials that caused the deaths of thousands of trial subjects. In turn, a growing number of trial sponsors have been driven out of the country to other Read more…