Pharmaceutical Executive Europe - March 2007 - (Page 16)

Selecting South Africa Michelle Middle and Pierre Jordaan look at why you should consider South Africa when looking at new locations for your clinical study. here are three main reasons encouraging companies to conduct clinical research in another geography: expertise, patients and pricing. But as more and more emerging markets become possible research destinations for global clinical studies, bio/pharmaceutical companies can find themselves spoilt in the number of geographies to choose from, or rather perplexed concerning to whom they should entrust their clinical development. Contract research is a rapidly growing sector of the industry, with more and more clinical research organizations CROs entering the market every year. As a result, it has become increasingly difficult for clinical development teams to determine which potential partner to select. Bio/pharmaceutical companies should look to a partner not only to understand the study complexity and have extensive therapeutic expertise but also to understand the issues that need addressing and to anticipate any pitfalls before the study commences. Especially with international studies, it is important that the service provider has global capabilities and deep understanding of the local market from many perspectives, including both clinical and regulatory. The best-designed clinical study is useless without adequate patient numbers and experienced investigators. With a specific patient population, one may need to enrol more study sites or extend T recruitment over a protracted timeframe. Both of these factors may add uncertainties to the data quality. The site effect or a phase effect may both serve to lower the statistical power of the study and thence the validity of the study results. Realistic feasibility projections are important and can only be trusted if they are based on prior studies or on a sound track record of previous studies at the same site. An obvious difference between countries is the cost differential. Many studies have been allocated to lowcost units or countries only to be re-performed at another, more expensive, study site later. This is a painful lesson both in terms of time and finances. ‘Expensive’ does not mean better, and ‘inexpensive’ work does not always result in savings. The burgeoning total cost of ownership may increase due to ineligible subjects, poor data quality, delays in data processing, or unreliable or ambiguous study results; this can, and very often does, lead to the irrevocable breakdown of relationships between the service provider and the bio/pharmaceutical company. South Africa’s untapped potential Clinical research has been conducted in South Africa for more than 30 years, the first bioequivalence studies being performed by academia. Dedicated research units and clinical studies followed in time; at present, MARCH 2007 CLINICAL TRIALS MANAGEMENT 16

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007

Content
Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna

Pharmaceutical Executive Europe - March 2007