The Ambulance Service Association represents all 35 NHS ambulance services across England, Wales, Scotland and Northern Ireland. The public ambulance services of the Isle of Man, Gibraltar, Guernsey and Jersey bring our total membership to 39. Contact details for all our member services can be found here. Together, our members employ over 34,000 ambulance and [...]

Bridging Studies – The Global Significance

With pharmaceutical and biotech industries being increasing forced to introduce internal efficiencies, it has become imperative for companies within such industries to enforce these efficiencies on external providers. Bridging studies by Richmond Pharmacology offer one way for these companies to maximize on their return on investment (ROI) in their R&D expenditures.

bridging studiesThe recruitment of subjects for clinical trials is a high priority for biotech and pharmaceutical companies deciding on the country and CRO to award their study to. The last thing a company wants is to end up with delays while conducting their clinical trials. Such delays may be due to insufficient recruitment of subjects, which in turn delays the compound development timelines, thereby forcing the company to increasing their expenditure in R&D. It is therefore important for outsourcing managers and project teams to carefully select their third party providers. While it is possible for any CRO across the globe to conduct healthy volunteer clinical trials, healthy volunteer trials in specific populations would require careful consideration with regards to geographic and CRO-specific placement. This requirement would especially apply with regards to trials of Japanese healthy volunteers.

Second in size to the US, the Japanese pharmaceutical market has witnessed changes by regulators in Japan aimed at the development and introduction of new chemical entities (NCEs) for the Japanese market. These changes in turn heralded a transformation in the development process of NCEs within this particular population demographic. This was and is still regarded as essential for biotech and pharmaceutical sponsors that wish to expand their presence in the Japanese market. Before these changes took place, NCEs would reach the Japanese market often much later after other countries. This delay was primarily due to the perceived lack of availability of potential volunteers, as well as the costs associated with such research.

In 1998, the Pharmaceutical and Medical Devices Agency (PMDA) of Japan adopted the International Conference on Harmonization (ICH) “Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data”. This recognized procedures under which clinical trial data that was gathered in one region could be utilized for purposes of fulfilling certain regulatory requirements in other regions. This deviation in approach initiated the drive towards studies that involved Japanese subjects and were conducted outside Japan. This, along with the PMDA’s acceptance of clinical data from non-Japanese patients in 2007 has assisted in bringing NECs to the Japanese pharmaceutical market, in a manner that is both time and cost efficient.

In any case, the PMDA has very strict requirements concerning the generation of clinical data from clinical trials conducted outside Japan on Japanese and non-Japanese subjects. Therefore, what makes certain CROs stand out for Japanese and non-Japanese based biotech and pharmaceutical sponsors is their ability to adhere to these strict regulations, as well as being able to find suitable subjects and carry out clinical trials in a manner that is both time and cost efficient. Some CROs will therefore always stand out when companies are considering placing clinical studies outside Japan with the aim of submitting the data to the PMDA.

Visit www.bridgingstudies.com for more information about Japanese Bridging Studies or alternatively click here.

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