Image credit: wladimir1804 | stock.adobe.com

Introduction

The increasing focus on diversity in clinical trials by regulatory authorities worldwide, combined with the ongoing need to expand pools of eligible patient participants, is leading many sponsors to explore opportunities for research in developing countries that have not historically participated in large-scale, industry-sponsored clinical trials.

One case in point is Indonesia, a developing country in Asia and, with 275.5 million people, the fourth most populated country in the world.¹ The country’s pharmaceutical market is the largest among the Association of Southeast Asian Nations (ASEAN) countries, with a total value of around $3.3 billion and a 10%-14% annual growth rate.² In the past two decades, Indonesia has also experienced significant growth in healthcare infrastructure, with numbers of physicians, hospitals, and primary healthcare facilities all increasing significantly.²

Like other developing economies, Indonesia’s disease burden is shifting as rates of infectious disease (ID) trend downward while rates of non-communicable disease (NCD) morbidity and mortality are increasing. While Indonesia still has a high ID burden, including malaria, tuberculosis (TB), and dengue, the country has made progress against these diseases. For example, malaria cases in Indonesia decreased from 1.1 million to 659,000 between 2015 and 2019, and it is estimated that 75% of Indonesia’s population now live in malaria-free communities.³

Indonesia is also making steady progress—including significant improvements made in TB detection and reporting over the past two years—towards elimination of TB, with a goal of reducing TB incidence to 65 per 100,000 population by 2030.⁴ At the same time, NCDs such as cardiovascular disease, cancer, and diabetes now constitute the major health burdens in Indonesia and top the list of leading causes of death.⁵

Despite these trends, Indonesia has hosted fewer clinical trials—and in particular, fewer industry-sponsored clinical trials—compared to other ASEAN countries.² Some reasons for this likely include:

Uncertainties related to clinical trial capacity (e.g., availability of local researchers, levels of expertise and specific skill sets).

Unfamiliarity with Indonesia’s study start-up and regulatory requirements/timelines.

Perceived challenges related to Material Transfer Agreement (MTA) requirements for the export of blood samples and/or specimens, where a central lab is utilized for multi-regional clinical trials (MRCTs).

Several encouraging signs, including recent commitments by Indonesia’s Ministry of Health (MOH) to boost the country’s clinical research industry, suggest the country has significant potential for becoming a regional and possibly a global leader in clinical research. In turn, advancement in this area holds promise for improving Indonesia’s people and healthcare outcomes, while also advancing clinical research worldwide.

Indonesia’s Clinical Trial Landscape

Indonesia’s experience conducting clinical trials spans more than 20 years. The pace of clinical research accelerated during the COVID-19 pandemic, when Indonesia made improvements to the regulatory approval process that reduced study start-up times down to six to nine months from the roughly two years of the pandemic.

As a result, several large-scale clinical trials for COVID-19 vaccines were conducted across the country, proving Indonesia’s capability for conducting high-quality, multi-country clinical trials (i.e., studies undertaken by Indonesia and involving other countries globally). In fact, the number of multi-country clinical trials being conducted is now greater than the number of single-country (Indonesia only) clinical trials.

Sponsor types and therapeutic areas of focus

Based on Trialtrove data for the period January 2018 to November 2023, most of both multi-country and single-country clinical trials in Indonesia are being sponsored by the academic sector (52% and 54%, respectively), followed by industry (21% and 17%) and government (9% and 6%).⁶ Therapeutic areas of focus are roughly similar for both trial types, with the top five being infectious disease, metabolic/endocrinology, vaccines for ID, central nervous system and autoimmune/inflammation clinical trials. Additional therapeutic areas of interest include cardiovascular, oncology, ophthalmology, and genitourinary conditions.

Phases of studies

Between January 2018 and November 2023, clinical trials—both multi-country and single-country—have been distributed across phases but the majority have been later phase clinical trials, including a high number of Phase IV trials. As Indonesia gains clinical trial experience and improves start-up timelines, it will become more attractive for sponsors to bring earlier phase studies to Indonesia.

Target patient populations and vulnerable populations

According to an observational study of records from clinical trial databases,² target patient populations of clinical studies in Indonesia have been primarily adults (age 18 and above). This is particularly true for MRCTs. Clinical studies with vulnerable patient populations including children (age 1-18 years old), infants (under 1 year old), elderly (above 50 years old), and pregnant women were found in higher proportions in regional clinical studies vs. MRCTs.²

As a country with a large population, there is also potential untapped opportunity in Indonesia to conduct clinical trials in rare disease. Two important resources to tap for rare disease clinical trials include the National Rare Disease Foundation in Indonesia and the newly established government hub for rare disease research within the National Biomedical Genome Science initiative (NBGSi).

Opportunities for Indonesia

There are encouraging signs that Indonesia’s government is taking meaningful steps to bolster its clinical trial industry. For example, in July of 2023, the MOH signed a decree establishing the national Indonesia Clinical Research Center (INA-CRC).

Its function is to coordinate and facilitate clinical trial across all hospitals, serving as a catalyst for accelerating the implementation of health research in Indonesia. Under this regulation, the government mandates that each hospital establish a Clinical Research Unit and engage in capacity-building initiatives. The purpose of this requirement is to ensure that hospitals are adequately prepared to serve as sites for clinical trials.

This directive aims to enhance the research capabilities of hospitals, thereby contributing to the advancement of medical science and patient care on a national and global scale. Indonesia has also adopted Good Clinical Practices (GCP) and required all clinical researchers to be GCP-certified as regulated by the MOH and BPOM.² In addition, ethics committees have been established by national, and teaching hospitals, several national top-rank Faculty of Medicine, and subsequently accredited by the National Health Research and Development Ethics Committee and Forum for Ethical Review Committees in Asia and the Pacific.

However, more funding and investment are still needed, especially in areas related to infrastructure development, capacity building and research grants. Investing in state-of-the-art research facilities and cutting-edge technology, including clinical laboratories for research, will not only enhance the capabilities of clinical research units but also attract international collaboration and investment.

Furthermore, bolstering research grants and incentives for both public and private sector stakeholders can stimulate innovation and drive the development of novel therapeutics and medical devices. Fostering a conducive regulatory environment through streamlined approval processes and transparent guidelines will encourage greater participation from pharmaceutical companies and academic institutions in conducting clinical trials within Indonesia.

Opportunities for sponsors

Indonesia appears on to be the cusp of developing into a clinical research center of excellence in Southeast Asia. Sponsors have the opportunity to benefit from Indonesia’s growing clinical research capacity (and contribute to it, as well), while also gaining access to Indonesia’s large and diverse population. Indonesia is also an ideal market for the conduct of certain clinical studies (e.g., biosimilars), biologic products where the need is urgent (e.g., vaccines), and for medical products and devices utilizing cutting edge technologies, which may have a better chance of being marketed in Indonesia because there is little competition at this time.²

The Indonesia MOH’s NBGSi is revolutionizing healthcare in Indonesia through precision medicine. NBGSi is currently collecting baseline genomics data from nine hospitals that focus on infectious diseases (tuberculosis), cancer, brain and neurodegenerative diseases (with initial focus on stroke), metabolic diseases (with an initial focus on diabetes mellitus), psoriasis, rare diseases (with a specific focus on Duchenne Muscular Dystrophy and pulmonary arterial hypertension), maternal and pediatric health and cardiovascular disease, forming a crucial foundation for personalized medical treatments tailored to Indonesia’s diverse genetic landscape.

Meeting Current Challenges

The MTA Decree

In any country, the regulatory environment can have a significant impact on the number of clinical trials and how they are conducted. In Indonesia, a notable instance of this followed a decree issued by the MOH in September 2009 mandating an MTA before samples can be sent out of the country, such as to central laboratories commonly used in MRCTs. It’s important to note that the MTA is not unique to Indonesia—for example, China also has an MTA in place, which the country has helped sponsors manage by establishing its own central laboratories.

While initially the MTA decree did have a negative impact on the number of MRCTs conducted in Indonesia, real-world experience since then suggests that the MTA requirement may be less of a hurdle than perceived and can be achieved in one-two months, on average. Furthermore, the MOH is currently revising the MTA decree with the goal of making the requirements and approval process simpler and more transparent, which in turn, should help to increase confidence among industry sponsors and accelerate timelines.

What’s on the Horizon?

Building site capacity

Facilitating study start-up, accelerating timelines, increasing predictability in clinical trial delivery, and promoting diversity and inclusion in clinical trials depend, in large part, on the existence of well-established clinical research sites with experienced staff. This level of clinical research capacity is not yet widely available in Indonesia.

To help address this challenge, Syneos Health, a leading fully integrated biopharmaceutical solutions organization, has been working to develop sites within Indonesia that are new to clinical research through its global Catalyst Site Network. The very first Syneos Health global and regional “New to Clinical Research” Catalyst Site was established on March 19, 2024 at Mayapada Hospital Jakarta Selatan.

Regional collaborations

A collaboration between Clinical Research Malaysia (CRM) and Indonesia is under active discussion. CRM was started in 2012 to provide a strong foundation for supporting clinical studies at the national level—including by providing study coordinators to study hospitals throughout Malaysia—and for transforming Malaysia into a global clinical trial hub. Since its inception, the presence of CRM has contributed to the significant growth of clinical studies in Malaysia.²

As such, it is a role model for the kind of national-level management Indonesia needs to support an environment conducive to high-quality clinical research. Indonesian delegates from the Mayapada Hospital Jakarta Selatan (a Syneos Health Catalyst Site) attended the CRM Connect Conference in May 2024 and also visited two hospitals in Kuala Lumpur to observe and learn how clinical trials are conducted in Malaysian hospitals.

The Singapore Clinical Research Institute (SCRI) is the national academic clinical research organization to enhance the standards of clinical research in Singapore by developing core capabilities, infrastructure, and scientific leadership for clinical research. SCRI signed a Memorandum of Understanding (MOU) with ONWARD Health Research in March 2024 to open doors for collaboration to nurture Clinical Research Coordinator (CRC) talent in Indonesia. This MOU aims to deepen understanding of the healthcare research landscape in both Singapore and Indonesia and identify potential areas for collaboration, such as adapting training programs by SCRI Academy to further enhance the skills of CRCs in Indonesia.

Indonesia Clinical Research Program Developments

Building on the successes observed in neighboring countries, Indonesia is aiming to emerge as a leading regional destination for clinical research. The INA-CRC is dedicated to being the leading force in advancing clinical research throughout the nation. With a focus on collaboration, INA-CRC aims to streamline processes, elevate standards, and foster innovation in clinical investigation. Through strategic partnerships and capacity-building initiatives, INA-CRC seeks to catalyze growth in Indonesia’s clinical research landscape, driving scientific progress, improving healthcare delivery, and enhancing patient outcomes nationwide.

Conclusion

Thanks to numerous regulatory and capacity-building initiatives, as well as regional collaborations involving the industry and academic sectors, the future looks bright for Indonesia as a center of research excellence at both the multi-regional and regional levels. This is good news for the people of Indonesia, who stand to benefit from greater access to new therapies addressing national health issues, and from further development of the country’s healthcare system overall.

This is also good news for sponsors, whose needs for global research capacity are increasing along with the need to increase diversity and representation in clinical trials. Indonesia is an ideal market for many kinds of studies, including urgently needed vaccine and pediatric nutrition clinical trials and for medical products and devices utilizing cutting edge technologies, particularly for products that will be marketed in the country. The Indonesia MOH’s NBGSi is working to revolutionize healthcare in Indonesia through precision medicine tailored to Indonesia’s diverse genetic landscape.

Because this is a dynamic period of growth and change, Indonesia’s regulatory and healthcare landscape remains nuanced. Navigating it at this time requires practical local insights gained through on-the-ground experience in Indonesia as well as insights gained from work in other countries in the region. Just as importantly, it requires the ability to build relationships and the desire to collaborate and help build Indonesia’s research capacity to benefit the people of Indonesia and global health.

Acknowledgements

• The authors wish to thank the following for their thoughtful perspective and input to this paper:
• The extended team at Indonesia Ministry of Health.
• Anna Ching, Associate Director, Clinical Operations APAC, Syneos Health.
• Marlinang Diarta Siburian, Department of International Trial, National Center for Global Health and Medicine, Indonesia.

About the Authors

Lena Low, Executive Director, Clinical Operations APAC, Syneos Health.

Martin Lim, Co-founder & CEO of Onward Health Research.

Terttu Haring, President, Site & Patients, Syneos Health.

Serena Chan, Vice President, Clinical Operations APAC, Syneos Health.

David Gebbo, Director, Clinical Operations APAC, Syneos Health.

Lucia Rizka Andalucia, Director General of Pharmaceuticals and Medical Devices, Indonesian Ministry of Health and Acting Head, Indonesia National Agency of Drug and Food Control.

Roy Himawan, Director of Pharmaceuticals and Medical Devices Resilience, Indonesian Ministry of Health.

Indri Rooslamiati, Acting Director for the National Biomedical and Genome Science Institute.

Dona Arlinda, Team Leader, INA-CRC, and the team from Indonesian MOH and INA-CRC.

References

1. World Bank Open Data. https://data.worldbank.org/indicator/SP.POP.TOTL?locations=ID

2. Siburian MD, Muchanga SMJ, Villanueva AFDR, Setiabudy R, Tatsuo I. The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases. Global Health Journal.2020;(4):87-95. doi.org/10.1016/j.glohj.2020.08.003

3. World Health Organization. Indonesia: evidence-informed action to eliminate malaria in Indonesia. https://www.who.int/about/accountability/ results/who-results-report-2020-mtr/country-story/2021/indonesia

4. World Health Organization. Making TB everyone’s business—Indonesia’s path towards eliminating TB. https://www.who.int/indonesia/news/ campaign/tb-day-2021

5. Centers for Disease Control and Prevention. CDC in Indonesia. https://www.cdc.gov/globalhealth/countries/indonesia/default.htm

6. Trialtrove®, Nov. 2023.