Service Insight: Due diligence in emerging markets for clinical development
pharmafile | May 4, 2011 | Feature | Research and Development |Â Â Service Insight, Talking Point, research and developmentÂ
SERVICE INSIGHT
Currently, the pharma industry is experiencing an unprecedented wave of blockbuster drug patent expiries.
There is a lack of innovative new drugs available, pharma and biotech are having to diversify their portfolios and tap into the high growth emerging markets. There are more and more clinical development activities now.
The disease profiles in the emerging markets have been shifted toward the high prevalence of diseases of the developed world, such as stroke, obesity, cardiovascular, CNS and oncology diseases.
The growth in clinical trials conducted in emerging markets is driving an increase in the need for sponsors to choose development partners to these markets with rapid speed.
In its wake is an increased focus on understanding the best ways to make clinical trials in these countries work. The need to accelerate drug development coupled with regard for patient well-being and safety, has spurred interest in how clinical trials are conducted in these countries.
The need for well conducted trials utilising International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) standards on a global scale not only ensures patient safety and well-being, but accelerates the development of drug therapeutics that will be a deciding factor in improving both the quality of life in these markets, and creating lucrative new markets for biopharmaceutical companies.
That said it is critical for biopharmaceutical companies to conduct due diligence, and choose development partners with the services and global scale to adhere to these principles.
For this purpose let us talk about development criteria in the key markets of China and India. What do these markets have in common and what are some of the differences to consider in the drug development climate there?
Similarities in country demographics for clinical development
China and India share many commonalities in terms of investigator access to large treatment naive patient populations. Both countries share benefits based upon lower cost operations and western-educated therapeutic experts.
The scale of this patient population allows sponsors to achieve large economies of scale and operational cost savings as a result.
China, home to a 1.4 billion population, also has a prevalence of many types of disease.
Most large hospitals are government-run investigative sites and are located in the major cities, lending operational efficiencies because of patient concentration. All investigators are ICH/GCP compliant with CA and IRB approval processes for the last 10 years.
Most investigators are English-speaking and the country has invested heavily in its infrastructure, providing ease of integration with other global markets participating in a study.
India has a growing middle class which is yielding a highly educated medical and technical scientific talent pool. This level of expertise yields excellent quality data management and technologic platforms to support clinical trials. India, of course, has a largely naive patient pool that demands new technology and therapeutic treatments to improve their healthcare and wellbeing.
Contrast in regulatory environment
The most dramatic differences between these two markets are regulatory guidelines with regard to both study approval timelines, and the allowance for import/export of both trial drug and laboratory samples. China in general is stricter with regard to drug imports and the various regulatory approvals needed for study start-up. The regulatory approval process is a lengthy one. Also, China does not allow blood and/or biological samples to be shipped out of China for testing without permission. India on the other hand has a far more predictable regulatory timeline, and a shorter approval process by comparison.
Considerations for selecting a development partner:
Local Expertise
When choosing emerging markets for trial conduct, it is always best to understand the local level of expertise. In general, clinical development partners that have local relationships and an understanding of the regulatory process will fare better. These experts on the ground will understand not only the approval process, but have connections with key opinion leaders and local investigative sites for the appropriate patient populations.
Full service facilities with central labs
A key factor seen in both China and India are the availability of full service partners, especially in the use of CAP accredited central labs. China in particular does not allow the export of laboratory specimens. The logistical use of central labs in these locations is a must to both accelerate the trial process, and save money from shipping costs. In addition, the availability of integrated laboratory facilities with the clinical trial project teams contribute to seamless operations.
Knowledge of regulatory environment
One common mistake in conducting a global trial is underestimating the time frames for regulatory submissions within the country’s appropriate authorities. The speed of study start-up is dependent upon robust submissions to local ethics committees; local and central IRBs and other local authorities for patient recruiting; study drug distribution; informed patient consent; investigator site approvals, and material transfer.
Common technology platform for study management
The ability to run concurrent country trials depends on selecting a partner with a web- enabled central communication and project management package. Software solutions encompassing study management, laboratory activities, patient randomisation, and data collection must be integrated to enable global communication and decision support.
A cohesive technology solution is a must when selecting a development partner.
The bottom line
Whilst developing drugs in emerging markets can be a daunting task, the advantages gained in terms of an improved speed-to-market can far outweigh the associated risks. However, only those sponsors who conduct due diligence with regard to choosing a truly full-service, development group with local expertise on the ground, can expect to succeed.
The interest in how drugs are developed in emerging markets will continue to create fodder for those who do not understand the complexities associated with bringing new drugs to market. However, as the biopharmaceutical industry employs best practices in choosing a partner on a global level, the odds of developing drugs that improve the quality of life for millions of patients in these countries are that much greater.
Dr Dan Weng is vice president, Medpace Rest of World (ROW). For more information visit: www.medpace.com
For more information on Service Insight features contact InPharm’s sales team on +44 (0)1243 772 010 or email pharmafilesales@wiley.com
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