New insurance template for Swiss clinical trials

The 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.

ABPI sets new clinical trials standards; compensation regulations amended

The Association of the British Pharmaceutical Industry (ABPI) recently released updated guidelines for all UK clinical trials beginning January 1st, 2015. The standards consist of two main sections:

• Phase 1 Clinical Trials Compensation Guidelines
• Phase II, III and IV Clinical Trials Compensation Guidelines

FDA officials warn drug makers: comply or face sanctions

Having 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

Computer simulators mean heightened standards for clinical drug trials

Recent 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

Costs and larger trials among the factors driving the globalization of clinical trials

Although significant drug and medical device R&D activity remains within the United States, representing close to 50% of total worldwide expenditures over the last 10-15 years, a clear trend toward globalization has emerged. Many would argue that cost is the primary factor driving this development, however, research suggests that other key factors are contributing as well. Some of these factors include an overall increase in R&D activity, lower enrollment rates in developed countries, and larger trials. It is currently estimated that 50% of all pivotal clinical studies contain data from foreign trials.

We see many drug and medical device companies go overseas to supplement or use as a substitute for U.S. based studies, what surprising is that Western Europe is no longer the only destination.

Pending changes to insurance standards for Russian clinical trials

Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.