Managing clinical trials in Asia: Issues, threats, opportunities and approaches

Rahman, Syed Abidur; Majumder, Anwarul Azim

doi:10.3329/seajph.v2i2.15961

Cited by 7 publications

(5 citation statements)

References 15 publications

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“…[211] Asia is also the most populated continent in the world, with more than half of the world's population. [131415] In addition, the clinical trial cost in Asia is about 30%–40% lower than the USA and the EU,[2] with the combined cost for each patient per visit in China, India, and Thailand nearly equivalent to per patient per visit cost in the USA alone. [2]…”

Section: Discussionmentioning

confidence: 99%

Clinical trials in Asia: A World Health Organization database study

2019

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Background and Objective: The Asian continent appears to be a growing destination for conducting cost-effective clinical trials, utilizing the available pool of treatment naïve subjects. This study aims to determine the growth rate of clinical trials in Asia. Methods: A database review was conducted. Registered clinical trials conducted in selected countries in Asia, Europe, Australia, and North America between 2008 and 2017 were searched from the International Clinical Trial Registry Platform. Compound Annual Growth Rate was determined for registered clinical trials. Results: During the 10-year period, a total of 125,918 registered clinical trials were conducted in Asia. There was a 7-fold increase in the number of registered clinical trials in Asia. More trials were registered in Japan than any other Asian country (30.8%). The average annual increase in the number of registered trials was generally higher in Asia than the United States of America, Canada, EU countries, or Australia. Iran recorded the highest average annual increase in the number of all clinical trials in Asia (41.9%). The number of pediatric clinical trials in Iran also increased annually by an average of 30.4%, more than any other country included in this study. Conclusions: Clinical trials recruitment in Asia is increasing faster than Europe, North America, and Australia. Lower trial cost and large patient pool may be contributory to this increase.

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Section: Discussionmentioning

confidence: 99%

Clinical trials in Asia: A World Health Organization database study

2019

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“…High clinical trials cost, financial crises, limited patient pool, and other administrative expenses have prompted the study sponsors of North America and Western Europe to look for an alternative destination in order to cope with this dilemma. 6 It is prudent to conduct feasibility for clinical trials that eventually provides optimum results; it's not deemed viable to conduct a clinical trial without looking at the incidence of the target disease in a selected country. Likewise, Asian countries provides more study subjects for an oncology trials while the pool of an oncology patients have already been consumed in the west.…”

Section: Figure 1: Percentage Of Total Clinical Trials 31mentioning

confidence: 99%

“…In comparison to earlier data, there has been a decline in the total number of clinical studies in India, Thailand, Singapore, and Malaysia during the last 5 years; this decline trend is disconcerting which occurred due to the collective fall of phase 3 trials. 6 Fabricated data and uncertain regulatory environment have jolted India's clinical trial market despite of having an enormous potential for the recruitment of treatment naïve patients, thus prompting pharmaceutical companies to conduct clinical trials in other Asian countries. 10 The concept of four color light strategy was introduced by China Food and Drug Administration (CFDA) in 2015 that streamlined the drug approval process, thus encouraging sponsors to conduct clinical trials in China without facing delays in site initiation that usually occurs owing to lengthy ethical and regulatory approvals.…”

Section: Figure 1: Percentage Of Total Clinical Trials 31mentioning

confidence: 99%

Challenges of conducting clinical trials in Asia

Egunsola¹,

Babar²,

Hasan³

2018

Int J Clin Trials

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<p class="abstract">Unlike North America and European Union (EU), Asian continent appears to be an ideal destination for conducting cost-effective clinical trials utilizing the pool of treatment naïve subjects. With a population approaching 4.5 billion, recruitment of subjects can be done without a fear of limited patient pool across Asia. The burden of infectious and chronic diseases is also higher in Asian countries. The emerging clinical trial markets particularly China, South Korea, and Taiwan offers genetic diversity in population group, thus promoting the quality and generalizability of clinical trial’s data. Nonetheless, several challenges also exist for the Western sponsors in majority of the Asian countries; regulatory, operational and infrastructural challenges are at the forefront. Challenges under the heads regulatory, operational, infrastructural, language and cultural, ethics, and future challenges have been discussed. SWOT analysis of Asian clinical trial’s market exhibits enormous opportunities for study sponsors with manageable threats.</p>

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“…In addition, with nearly 60% of the world population residing in Asia, countries within this region will be able to offer large and genetically diverse patient pools. This would complement the patient pools in occidental countries 9 . A recent review has examined the open‐access clinical trial registry clinicaltrials.gov for registered interventional recruiting early phase trials (Phase I/II) in the BRIC (Brazil, Russia, India, and China) countries and found that China accounted for 95% (842/888) of the trials; with gastrointestinal (17%, 148/888), lung (11%, 94/888), and breast (17%, 53/888) cancers being the most studied.…”

Section: Early Phase Oncology Clinical Trials In Asiamentioning

confidence: 99%

“…This would complement the patient pools in occidental countries. 9 A recent review has examined the open-access clinical trial registry clinicaltrials.gov for registered interventional recruiting early phase trials (Phase I/II) in the BRIC (Brazil, Russia, India, and China) countries and found that China accounted for 95% (842/888) of the trials; with gastrointestinal (17%, 148/888), lung (11%, 94/888), and breast (17%, 53/888) cancers being the most studied. This review has also highlighted that early phase trial testing in hematology and oncology has increased significantly throughout Asia, especially in China, which now has 18.5% of the global population.…”

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confidence: 99%

Early phase oncology clinical trials in Malaysia: current status and future perspectives

Voon

Wei

Bustaman

et al. 2022

Asia-Pac J Clncl Oncology

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Historically, the majority of oncology clinical trials are conducted in Western Europe and North America. Globalization of drug development has resulted in sponsors shifting their focus to the Asia-Pacific region. In Malaysia, implementation of various government policies to promote clinical trials has been initiated over a decade ago and includes the establishment of Clinical Research Malaysia, which functions as a facilitator and enabler of industry-sponsored clinical trials on a nationwide basis. Although oncology clinical trials in Malaysia have seen promising growth, there are still only a limited number of early phase oncology studies being conducted. Hence, the Phase 1 Realization Project was initiated to develop Malaysia's early phase clinical trial capabilities. In addition, the adaptation of good practices from other countries contribute to the effective implementation of existing initiatives to drive progress in the development of early phase drug development set up in Malaysia. Furthermore, holistic approaches with emphasis in training and education, infrastructure capacities, strategic alliances, reinforcement of upstream activities in the value chain of drug development, enhanced patient advocacy, coupled with continued commitment from policy makers are imperative in nurturing a resilient clinical research ecosystem in Malaysia. K E Y W O R D S clinical trials, early phase oncology trials, Malaysia, oncology EARLY PHASE ONCOLOGY CLINICAL TRIALS IN ASIACancer ranks as a leading cause of death and an important barrier to increasing life expectancy globally, accounting for nearly 10 million deaths in 2020. 1 The overall burden of cancer incidence and mortality is growing rapidly, and this reflects both aging and growth of the population as well as changes in the prevalence and distribution of the main risk factors for cancer, several of which are associated with socioeconomic status.Oncology clinical trials are intended to evaluate the safety, toxicity, and efficacy of new anticancer agents and represent an essential component to drive advances in this field. 2,3 Historically, the majority of oncology clinical trials were conducted in high income countries, especially in Western Europe and North America. The reasons for this are multifactorial, including the availability of an established trial infrastructure incorporating both physical and manpower requirements, along with the geographical location of major pharmaceutical companies in these countries. 4 However, in recent years, globalization has resulted in a shift of this practice, with more clinical trials being conducted outside of Western Europe and North America, such as in Asia. One of the main reasons for this shift is attributed to the fact that clinical trial data are often collected from varied populations and ethnic groups to support a license application for a novel drug

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Managing clinical trials in Asia: Issues, threats, opportunities and approaches

Abstract: not available DOI: http://dx.doi.org/10.3329/seajph.v2i2.15961 South East Asia J Public Health | Jul-Dec 2012 | Vol 2 Issue 2 | 80-84

Cited by 7 publications

References 15 publications

Clinical trials in Asia: A World Health Organization database study

Clinical trials in Asia: A World Health Organization database study

Challenges of conducting clinical trials in Asia

Early phase oncology clinical trials in Malaysia: current status and future perspectives

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