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International Clinical Trials

Indonesia

As the pharma hub of the Association of Southeast Asian Nations (ASEAN) region, Indonesia has recently seen great progression and rapid advancement of technologies and service offerings. It has taken centre stage in terms of clinical trials, with 49 currently underway (1).

The Asia-Pacific region is known for having a comparatively shorter timeframe for clinical trial duration, as well as being relatively less expensive – with a population of almost 256 million people (2) and a high incidence of diseases, ranging from tropical diseases to diabetes, asthma and malaria (3). These factors, combined with Indonesia’s current surge in research activity, have opened the door for an increasing amount of clinical trials to take place in the country. Although clinical trial expertise have been brought from more mature research countries such as India, China and Taiwan in the past, local expertise is now essential for success.

Trial management has always been reliant on local knowledge in order to successfully carry out a clinical trial – it is vital to the entire process. Factors such as cultural sensitivity, patient adherence and communication are heavily dependent on local insight, which help provide a bigger pool of patients and usable data in a shorter time. The question of how to contact patients, as well as the best way of managing adherence in terms of communication methods, relies on the local expertise of researchers. For example, information on how the internet has penetrated the population, and what the patient’s preferences in communicating are, prove to be of great importance. Their habits and uses of technology are significantly beneficial in how to best interact with patients, and therefore how to best manage the trial.

In fact, Indonesia is one of the most ethnically diverse countries in the world, and while Malay is the main language, there are still over 700 indigenous languages spoken in the territory – making speaking skills all the more important. Throughout the trial, doctors need to be able to communicate with the patient so they can see how effective the drug is, what side effects might be occurring, and any other factor relating to their care.

Moreover, Indonesia also presents major distribution challenges for both healthcare providers and clinical trials. The country comprises 17,000 volcanic islands, and local knowledge will be central in identifying the best and most viable transport routes, distribution centres and companies.

Finally, the gentrification of the country provides ongoing challenges for clinical studies in the region, as it is a rapidly evolving healthcare structure. Thus, local expertise is vital in understanding the current practices in the country. The ASEAN region also holds the world’s largest population of people that have never undergone treatment or a clinical trial, which means that they need a more prescriptive approach in terms of educating and walking them through trials.

Regulatory Approval


The ongoing harmonisation across the ASEAN region is expected to accelerate growth and foreign investment; without local knowledge, however, companies looking to attain regulatory approval will find the process challenging. For example, in Indonesia – as in other Southeast Asian countries – the Ethics Committee (EC) approval letter needs to be enclosed within the regulatory submission package. Therefore, submission can only be made after EC approval, and this in itself can take between four and seven months. In a process where each day of delay means a reduction on their budget, having the upper hand in the bureaucratic and regulatory processes is critical.

References

1. CenterWatch, Indonesia Clinical Trials, 2016. Visit: www.centerwatch.com/clinical-trials/listings/location/international/ Indonesia
2. The World Factbook, East and South East Asia: Indonesia, CIA, 2016. Visit: www.cia.gov/library/publications/the-world-factbook/geos/ id.html
3. Ministry of Health, Republic of Indonesia. Indonesia Health Profile 2013. Visit: www.depkes.go.id/resources/download/pusdatin/profilkesehatan- indonesia/Indonesia%20Health%20Profile%202013%20 -%20v2%20untuk%20web.pdf

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Rutger Oudejans has been Brand Director Pharma at UBM EMEA since April 2014. He is a creative, strategic and highly experienced business leader, with handson pharmaceutical industry knowledge and a long track record in previous roles across Asia, focusing on functional excipients as well as formerly representing UBM's pharma division for several years. A core part of his responsibilities is to drive forward the CPhI Worldwide and CPhI India brands and co-located events.
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