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. Read more…
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.
A decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.
The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial. Read more…
