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Finding required numbers of patients is one of the greatest challenges for clinical trials today. According to a recent report, Phase III trials run an average of 30% longer than the pharmaceutical trial team’s original plan, or six months beyond expectation, with the most common hurdle being delays in patient recruitment. Furthermore, pharmaceutical companies spend 30% of the clinical trial timeline recruiting study participants (Source: Cutting Edge Information, October 2004).
Fortunately, Kendle’s global reach, clinical capability and strategic approach means we can create targeted programs based upon country-specific cultural and regulatory requirements to recruit and retain patients who meet your study inclusion criteria.
Our patient access services include expertise in identifying and ethically conducting trials in countries that possess large, untapped patient populations. Including these countries can boost enrollment in global studies. After identifying an appropriate site, we conduct a feasibility assessment for study delivery, which covers medical fit of protocol, available patient population, ethics and logistics. The feedback from this assessment, together with previous performance metrics, allows us to develop a study-specific strategy, including site and country-specific recruitment approaches and levels of motivation required.
We recognize that although optimal site and country identification clearly impact upon enrollment, many trials benefit from the increased exposure that is created through direct-to-consumer outreach methods such as radio, print and television advertising, direct mail and internet listings.
The Kendle patient recruitment team therefore develops outreach methods and materials to assist sites with the identification and notification of qualified patients. Although limited direct-to-patient outreach is allowed in some countries, others – like the US – rely more heavily upon advertising to attract potential patients due to less extensive referral systems, increased treatment options and competing trials. From posters to television advertising campaigns, our team can supply investigative sites with tools that increase trial visibility as deemed appropriate by local regulatory authorities.
Our relationship with qualified investigators and ability to select the right site for a study is our key to recruiting patients. Feasibility ensures that we select sites with access to the required patient populations. We also have an investigator database that ensures we choose the most appropriate and best sites for your trial.
This precise, strategic approach means we ensure rapid site start-up and ongoing site and patient motivation.
Our regional expertise
At Kendle, we offer study sites in traditional markets, supplemented with high recruiting sites. We also understand the need to find areas in the world that are not over-saturated with large-scale clinical trial activity in order to balance our industry’s more traditional approaches.
That’s why, in addition to established capabilities in most major markets around the world, our focus is on working ethically in emerging regions where there are large, concentrated populations of patients not previously involved in clinical trials. These areas include Central and Eastern Europe (CEE), Latin America, Africa and India.
Whatever the therapeutic area and indication, our regional experience means we can target the best region for your study. Our local experts understand and work efficiently within the culture, language and regulatory environments, and medical practices for each country in the region.
The strong enrollment and quality data achieved in many emerging regions accelerates clinical development, meaning the development cycle can be shortened sometimes by as much as 25% or more. This results in lower clinical development costs, faster time to market and a rapid return on investment. And importantly, trials conducted in these regions are in compliance with ICH GCP guidelines. However, we do recognize that frequently clinical developmental requirements prohibit the inclusion of emerging regions to increase enrollment rates.
Kendle delivers trials in CEE
We know that in Central and Eastern Europe there is a combined population of 400 million people, and patient productivity is 2–10 times higher than sites in the US and Western Europe (Source: European Pharmaceutical Contractor – Winter 2003).It is here that we have access to skilled, highly motivated investigators located in large, centralized healthcare centers, which helps to reduce the number of sites needed. The sizeable patient populations demand approximately 20% less compensation than those in Western Europe (Source: CenterWatch Monthly, April 2004), yet they are also highly motivated.
The increasing incidence of western lifestyle diseases in CEE is another important benefit of the region. Attractive therapeutic areas in CEE now include: psychiatry, oncology, cardiology, gastroenterology, endocrinology, pulmonology and neurology.
Kendle delivers trials in Latin America
We have identified Latin America as an important region for many of the same reasons as CEE. Latin America has a combined population of 490 million people, patient enrollment is 3–6 times greater per site than the US, and the discontinuation rate is half of that in the US on average. For example in a recent endocrinology trial, just 10 sites in Mexico yielded a similar number of patients to 40 US sites.
One other great advantage of Latin America is “seasonal reversal.” For example, when it’s winter in the US and Europe, we can carry out allergy studies in Latin America. Disease prevalence in Latin America is different – the population is not aging in the same way as the US and Western Europe. However, a major therapeutic area in Latin America is diabetes, with a significantly higher incidence of the disease than in other regions of the world. Time zones in Latin America also offer a favorable advantage for US studies 
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