Abstract of Master’s Dissertation
No.1
CourseMaster of Public Health

ThesisWhat policy/regulation impacts the number of Multi Regional Clinical Trials

Title

in ASEAN (Association of Southeast Asian Nations) countries?

Name

Chie Narita

Abstract of Master’s Dissertation
Background:
Clinical trials are essential to confirm the safety and efficacy of a new drug. Since 1998
when International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) initiated by EU, US, and Japan, the number ofclinical

trialsglobally has

been

acceleratedtoincrease,accordingtotheClinicalTrials.gov provided by the U.S. National Library of Medicine.
ASEAN (Association of Southeast Asian Nations) countries, especially several leading
ones in this area were stimulated by ICH movement and their governments have been
trying to set the national system to fit to the international harmonization. Since 2000,
they have produced several important regulations and laws which might influence thenumber of international clinical trials performed in those countries.
Objectives:
To identify possible or probable candidate regulations and laws which could influence
the number of Multi Regional clinical trials (MRCTs) by retrospective observation,
concordance of regulations and laws with any changes of annual number of MRCTs
were investigated.
To confirm those regulations and laws’ practical impact in each country, qualitative
investigation by individual interview with clinical trial professionals from regulatory
authority, industry, and institution, as three major roles involved in MRCT, wereperformed.
Materials and methods:
Annual number of MRCTs during a period between 2000 and 2020 were obtained
through the website, ClinicalTrials.gov. Related regulations and laws in each country
were selected by Analysis Report Identification and Clarification of the Differences inRegulatory Requirements between Asian Economies (APAC report) which have been
published every year. The interviews to the clinical trial professionals from regulatory,industry, and institution in ASEAN countries were conducted to ask if my hypothesis
about the causes (regulations and laws) and those results (increase or decrease of thenumber of MRCTs) is reasonable or not.
＊ The abstract, containing the objective, method, result and conclusion should not exceed300-500words and printed double sided on A4 paper)

Abstract of Master’s Dissertation
No.2
CourseMaster of Public Health

Name

Chie Narita

Results:
Two regulations were independently identified as influencing factors in Thailand andinthePhilippines,

namely“Parallel

invoice/shipment import license”.

clinicaltrialapplication”

and“perIn Thailand, the “parallel clinical trialapplication” was adopted in 2016 and increase of MRCT number was seen in 2018(+64.1% comparing to 2017). In the “Parallel clinical trial application”, ethicalcommittee (EC) review and regulatory review (for import license) can be done
simultaneously. The similar regulation change was seen in the Philippines (2019) but
the increase of MRCT number has not yet been observed. All nine interviewees fromboth Thailand and the Philippines answered that “parallel clinical trial application”
had positive impact. And seven interviewees agreed with my idea that the “parallelclinical trial application” contributed the reduction of timeline. From the interviewees,
other factors which impact the timeline of clinical trial start-up were pointed out.
Conclusion:
In this research, it was found that the “parallel clinical trial” application positively
impacted the MRCT number since it reduces the timeline to start the clinical trials.
However, I did not find any regulations and laws that reduced the number of MRCTs.
Further investigation is desired to expand wider range of factors. (483 words)＊ The abstract, containing the objective, method, result and conclusion should not exceed
300-500words and printed double sided on A4 paper)