Clinical Trials in the Indonesian Archipelago: Enter the Pristine Waters Slowly and Carefully

Jul 5, 2019 | Asia, Blog, Clinical Trials, Indonesia

Indonesia Clinical Trials

With nearly 270 million people Indonesia is the 4th most populous country.  Incredibly diversified in every way—from people, language and culture to geography and geology to history–this southeast Asian archipelago includes nearly 300 languages, a growing demand for middle class aspirations and a warm and dynamic culture.  An emerging economy, it has experienced strong economic growth over the past couple of decades.  The most populous Muslim population on earth, it has been influenced by foreign nations via colonization for hundreds of years. Groups such as the Dutch arrived for resource extraction and exploitation.  It achieved independence  from the Dutch in 1949—transforming power from the Dutch East Indies to local control. The process was helped along by Indonesian nationalists that fought the Dutch.  The Indonesia National Revolution marked the end of colonial rule.  The proud, diverse nation has experienced volatility since with brief periods of regional democracy countered by authoritarian pushes.  The country represents what we believe is a compelling region for clinical trials, but we take caution from Indonesia-based clinical trials expert Vince Grillo and his reference to an Indonesia proverb that statescalm waters doesn’t mean there are not crocodiles.”

TrialSite News concerns itself with clinical research transparency with the research site perspective.  What follows is an overview of the Indonesian healthcare system, pharmaceutical sector and clinical research activity including a list of the most active commercial sponsors and research sites.

Indonesia represents tremendous potential for clinical sponsors seeking longer term investment opportunity for development of clinical trial infrastructure for greater access to patients and markets.   We predict over time it will develop into a clinical trial location that will  support gold standard clinical research.  Plenty of risks abound but, where there are no risks–there are no returns.

Clinical Research in Indonesia Inc.

The following elements make Indonesia conducive as a future nexus of clinical research:

  • Large, diversified population that needs access to better healthcare
  • Low overall costs compared to the west
  • Treatment-naïve patient population
  • High number of infectious and chronic diseases
  • Ever improving regulatory conditions

Pharmaceutical Industry Rapidly Growing

Studies reveal robust growth in this large, youthful and dynamic country.  With 12-13% projected pharmaceutical growth its market could be valued at $6 billion by 2021—some claim over $10 billion. Over the counter drugs represents $3.4 billion and slower growth at 1.3%. The Indonesian Pharmacists Association reported that 95% of raw materials for medicines imported.  Most industry sponsors are foreign owned although there are domestic companies.  According to one source the company is home to 30,000 medicinal plants out of the 40,000 known plants.  The biodiversity that exists there is only matched by the Amazon Basin.

Although the country has traditionally lower rates of drug consumption compared to some other nations, OTC drug consumption per person has dramatically increased to $13.08 per person.  With growing GDP and per capital income this consumption will increase.  With a surge of chronic illness and a growing middle class overall demand will grow and by some estimates total healthcare spend in Indonesia will grow to $47 billion by 2022.

According to South Asian consultancy Cekindo, nearly 75% of the drug demand in Indonesia is met by domestic companies—25% driven by foreign companies. This data seems some what accurate based on TrialSite News analysis of regional clinical trials which evidences local companies such as Dexa Medical Group sponsor many more studies than foreign firms.  Indonesia has strong national pride and that is understandable given the controversial colonial past, however on the other hand the government will become more market-driven—opening the door for western ventures. According to some estimates here are 240 domestic manufacturers (mostly small and generic) however big western ventures are now circulating the area considering licensing deals.

The Indonesian government, nationalistic tendencies aside, seeks to open up its’ markets up and spur investment in the sector.  They modified ownership laws with to 100% full foreign-ownership inviting investment in the country. This has opened the floodgates.

Healthcare Indonesia Overview

Based on Ministry of Health data the country has 2,454 hospitals around the country with 305,242 beds—a very low figure of 0.9 bed per 1,000 inhabitants. The majority of the hospitals are in urban areas.

The government owns and operates 882 hospitals and the remaining are run by the private or non-profit sector.   Based on World Bank data there are 0.2 physicians per 1,000 people; 1.2 nurses  and midwives per 1,000 people-representing low numbers.

By some reports only 20 hospitals out of the total of 2454 have been accredited by the Joint Commission International (JCI) by 2015.  We provide the most recent JCI accredited list for the country.

It is reported that the government runs 9718 government financed Puskemas (health community centers) listed by Ministry of Health of Indonesia. These clinical offer comprehensive healthcare and vaccination services for the population in the sub-district level—perhaps also in more rural areas.  At least in some cases these regional clinics are utilized for clinical trials.

The community health system is structured in three (3) tiers including:

  1. Community Health Center
  2. Health Sub-Centers
  3. Village Level Integrated Posts

Universal Health Care Program Spurs Growth

The government launched Jaminan Kesehatan Nasional, JKN which is a universal health care program launched by the government in 2014. The designers aim to offer health insurance to all Indonesians by 2019. It is not clear how successful in totality the socialized healthcare access has become but it nonetheless drives more access and hence greater pharmaceutical consumption—especially for generic medicines.

Clinical Trials Regulation

We include a brief summary of clinical trials regulatory elements in the drug development process.  We follow by an overview of sponsor activity followed by a breakdown of prominent research sites.

Regulatory Process Introduction

Indonesia’s drug development industry is governed by the Indonesian Ministry of Health (Badan Pengawas Obat dan Makanan or “BPOM”). A sponsor can conduct studies directly or they may outsource to contract research organizations (CROs).  For study start up sponsors (or their CROs) must apply to BPOM and submit a statutorily required package of documents form protocol to informed consent and product documentation; to product information to other relevant sponsor and product information.

BPOM requires a sequential approval process.  The sponsor can apply to both ethics committee (EC) and scientific committee in parallel however approvals for the trial only occur after EC approval.

Study Start up /Regulatory Process

The sponsor must secure EC approval prior to applying to BPOM permission to initiate a clinical trial.  The BPOM will conduct a scientific and ethical clinical trial review—scrutinizing the protocol, informed consent, etc. However, the sponsor may apply to BPOM and the EC simultaneously; once EC has approved, BPOM will review the study start up package in consultation with a core group of national experts appointed by the agency.  Thus, approval or rejection will happen after this intensive review.  As with many government authorities, they may seek to clarify a question and request additional information—sponsors must expeditiously respond to such requests.  Upon final BPOM approval an approval letter will be sent to the sponsor.

The BPOM approval process may run one to two months and the EC process timeline is similar.  But there are of course risks for outlier events.

Post Regulatory Approval

Sponsors must be aware that the agency head maintains constant authority to investigate and potentially inspect a site prior, during or post clinical trial and can terminate the project if they deem a serious health risk present.

Once a study is up and running the sponsor (or their CRO) must notify BPOM on progress in six month increments; notice if the trial is terminated early and of course there are strict rules around prompt notice for any adverse events.  Moreover if there are changes to the trial procedure the sponsor may need to notify BPOM.

Other licenses may be required such as the export of biological materials from within Indonesia to outside of the country.

New Rules

The national authority (Ministry of Health) recently added new regulations in 2017 governing the marketing authorization of medical devices. Apparently, policies are in place now to streamline and accelerate approvals.  Moreover, the Indonesian government has set up a “National Single Window” portal accessed for applicants.

How Many Clinical Trials in Indonesia

TrialSite News research team ran an analysis of clinical trials within Indonesia.  At of this writing there were 92 active clinical trials within the country that are published in the Clinicaltrials.gov website.  A total number of 460 clinical trials have been conducted within Indonesia since data has been methodically tracked in the Clinicaltrials.gov website.

What about breakdown by sponsor?  Of the 92 active studies, 21 studies are industry sponsor-driven.  The number of therapeutic areas involved in clinical testing grows by the year but includes communicable and infectious disease and vaccines, metabolic and vascular diseases and lung and heart diseases, respiratory disorders, and increasingly oncology-related studies.  Other projects range from nutrition and public health studies to dental and pain management in various segments.

Behind Other Southeastern Asian Countries

Although Indonesia has a much bigger population than some of its neighbors such as the Philippines, Malaysia and Thailand these smaller countries conduct considerably more GcP complaint research than research sites in Indonesia.  There is growing pressure for change; this is reflected in considerable interest on the part of global commercial sponsors that seek to conduct clinical trials within Indonesia. The factors mentioned earlier such as large concentrated patient populations, patient profiles, etc. undoubtedly are a factor.

Prominent Sponsors

We studied active sponsors in the region. Clearly domestic pharmaceutical companies dominate existing research sponsorship, but this trend is shifting toward a more diversified reality.  Prominent Indonesia pharmaceutical company clinical sponsors include:

Many other international sponsors have established operations and now are sponsoring clinical trials in a variety of therapeutic areas including:

Of note we didn’t find a lot of big American-sponsors taking the lead but clearly the UK and Swiss appear to be in Indonesia in a big way.  Some prominent clinical research organizations (CROs) also materialize there in various alliances and deals.

Quintiles Deal

The export and import of biologic samples requires a government license. As was reported by PharmaVoice, biologic samples often need to be shipped for testing in a centralized lab for harmonization of results. Hence Quintiles (now IQVIA) entered into an agreement with Prodia Clinical Laboratory (an Indonesian CRO) to establish a CAP-accredited and NGSP-certified harmonized lab to support biologic samples on a local basis.  This opened up Indonesia to Quintiles—enabling it to market its country services in a more systematic and leveraged way.

Medical Schools/Academic Medical Centers

The top 15 medical schools in Indonesia (based on 2016 survey study from Pusat Data Analisa Tempo/Tempo Center of Data Analysis).

  1. University of Indonesia, Faculty of Medicine
  2. Andalas University, Padang, Sumatera Barat
  3. Gadjah Madra University, Yogyakarta
  4. Airlangga University, Surabaya
  5. Padjadjaran University, Bandung
  6. Diponegoro University, Semarang
  7. Universitas Hassanudin, Makkasar
  8. Universitas Sriwijaya, Palembang
  9. Universitas Sumatera Utara, Medan
  10. Universitas TRISAKTI, Jakarta
  11. Universitas UDAYANA, Denpasar
  12. Atma Jaya Catholic University
  13. Brawijaya University, Malang
  14. Maranatha Christian University, Bandung
  15. Sebelas Maret University, Surakarta

Clinical Investigational Sites

Although there are nearly 5,000 hospitals in Indonesia; and probably tens of thousands regional and local clinics– actual GcP ready facilities to support FDA-level, Gold Standard clinical research are less common.  TrialSite News maintains an industry-robust data base of clinical research sites worldwide.  We know of dozens of Indonesian research sites that have supported large, multinational sponsors for GcP compliant clinical research.

There is a whole industry of intermediaries that seek to profit from such information.  TrialSite News focuses on the public benefit mission in pursuit of the opening up clinical research—introducing transparency—so that the level of quality, safety and productivity rises. Ultimately, we want to see more GcP, certified research sites in Indonesia open for business for any sponsor of their choosing. In that spirit we offer a sampling of our known, active, GcP-ready clinical investigational sites in Indonesia. For           those interested in a deeper dive into Indonesian clinical investigative sites by therapeutic area contact us and we can provide more information.

Indonesian Clinical Investigation Sites

Conclusion

Indonesia, a complex and intricately beautiful and perplexing place—culturally, ethically, linguistically and geographically—ecologically with 30,000 of the known medicinal plants on the planet—represents a large and diversified archipelago of over 17,000 islands. Perhaps home to some of the most beautiful places on planet earth—a garden of Eden—it also represents a risky but potentially lucrative research center.  With its population, concentration of disease profiles and rapidly aspiring middle class desires we cannot help but believe Indonesia is an important place to get to know.

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