While any number of reasons may represent the actual impetus for such a change, the large drug companies are increasingly shifting their focus towards emerging markets and economies for the location of their drug trials. The reasons are varied and depend greatly on who you ask. Decreased costs, increased reach and an increasingly homogenized global disease profile rank high on the list. The objections against the trend are numerous as well, including decreased control, increased patient risk, little to no disclosure, however these risks may be mitigated by the ICH and GCP standards. Regardless of the ethical concerns, the trend towards globalization of clinical trials is clear.
While an entire post could revolve around the ethical concerns, what I find fascinating are the parallels between a company's selection process of an emerging market in which to launch a new business venture (according to HBP - Fundamentals of Global Strategy) and a drug company's selection of an emerging market populace for clinical trials. According to HBP, the key factors in selecting global markets are: a) market size and growth rate, b) a country's instutional context, c) competitive environment and d) cultural, geographic, economic and administrative distance.
The first and primary indicator of clinical trial acceptability is the similarity in country demographics (a,d), not only in disease state and prevalence, but also in regards to hospital administration, language, and access to medically and scientifically astute individuals. Next is the regulatory environment situation (b), as this factors heavily in time to market and import/export issues regarding drug, blood and biological samples.
As is the case in the market entry strategy involving identification and engagement of a strategic alliance/joint venture, selection of a local development partner is key to the parent company's sucess. Again, required drug trial partner capabilities correpond closely with those suggested by HBP as necessary to global growth: local expertise/knowledge (c), laboratory access (c), regulatory knowledge (b) and a common technology platform (c). It is fascinating how the tools and principles necessary for intelligent and productive global expansion are relatively universal no matter the end goal, market or players involved.
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