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Background and Purpose
With a population of 4.4 billion, the Asia-Pacific region accounts for more than half of the world’s population. Moreover, it is the largest region in the world by total gross domestic product (GDP).1 Nonetheless, significant disparities in healthcare infrastructure and provision exist across the region due to the diversity of socio-economic resources in each country. Overall, the burden of cancer incidence and mortality is rapidly growing in Asia. Furthermore, according to the global cancer statistics, Asia accounted for one-half of all new cancer cases and cancer deaths in 2020.2 The Asia-Pacific Gynecologic Oncology Trials Group (APGOT) was founded in November 2019 to bring attention to this issue.
‘The ultimate goal of the APGOT is to provide the best treatment to patients with gynecologic cancers on the basis of robust scientific evidence and enable every patient in every Asian-Pacific region to access a clinical trial (Figure 1A). The APGOT comprises a research network of international and regional clinical trial units that coordinates and promotes clinical trials within the Asia-Pacific region for patients with gynecologic cancers. This coordination is particularly relevant for academic clinical trials, translational research, research on rare diseases, and clinical trials sponsored by the industry to perform multicenter international studies in the Asia-Pacific region.
(A) The APGOT logo embodies an image of the Asia-Pacific clinical trial units moving forward together with one vision. (B) Founding members and the first organization of the APGOT in November 2019. For more information on APGOT’s mission and vision, please visit http://apgot.org/. ANZGOG, Australia New Zealand Gynaecological Oncology Group; APGOT, Asia-Pacific Gynecologic Oncology Trials Group; GCGS, Gynecologic Cancer Group Singapore; GOTIC, Gynecologic Oncology Trial and Investigation Consortium; KGOG, Korean Gynecologic Oncology Group.
APGOT Framework
Organizational Structure, Executive Committee, and Secretariat
The APGOT is overseen by an Executive Committee (Figure 1B), consisting of representatives appointed by the respective chair of the parties. The Committee shall be collectively responsible for providing overall direction and be the decision-maker on all major issues about the acceptance, management, budgeting, conduct, authorship, and publication of APGOT studies, and oversee the financial and administrative obligations to ensure the funds received meet all governance requirements.
The secretariat may be a staff member of any party and be appointed by the chairperson of the Executive Committee. The secretariat will help the chairperson and the Executive Committee organize and carry out biannual meetings, as well as maintain collaborative communications and activities among various APGOT member groups and sites.
Member Groups
Members of APGOT comprise clinical research groups and sites in the Asia-Pacific region focusing on gynecologic oncology. Founding members include the Gynecologic Cancer Group Singapore (GCGS), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Korean Gynecologic Oncology Group (KGOG), and Australia New Zealand Gynaecological Oncology Group (ANZGOG). The APGOT member groups have now expanded to include the Kolkata Gynecological Oncology Trial and Translational Group (KolGOTrg), Taiwanese Gynecologic Oncology Group (TGOG), and Shanghai Gynecologic Oncology Group (SGOG).
New study groups (or sites) need to apply with information on their capability for conducting trials and their management. APGOT accepts applications from clinical research networks of Asia-Pacific regions as well as high-performing individual research institutions from the Asia-Pacific region, where the formation of research groups may be challenging due to resource constraints.
Operation Process
Any member of the APGOT may propose and submit a new study proposal (Figure 2). The Committee will decide on the feasibility of the proposal. Priority and eligibility for authorship will be given to those investigators at sites that have contributed data. Badging of the APGOT trial should be given to meet the following criteria:
A proposal from one of the APGOT member groups
A proposed study must include at least two or more APGOT member groups or institutions contributing in terms of protocol development, patient recruitment, or translational research efforts
Industry collaboration is welcome as per the APGOT Industry Partnership Model, which is similar to the European Network for Gynaecological Oncological Trial groups (ENGOT) model3–5
Badging is contingent on approval by the Executive Committee.
Workflow of the APGOT studies. APGOT, Asia-Pacific Gynecologic Oncology Trials Group.
Meetings and Communication
The Committee shall meet at least once every 6 months during the calendar year. The Committee’s business meeting shall be held biannually in person or online. Official meetings for all APGOT members consist of ‘New trial proposal meeting’ and ‘Trial update meeting’, which would be held biannually. The Executive Committee meetings could be held concurrently with the official meetings. The owner of these meetings would be the clinical chair, and the operation chair or secretariat from the APGOT office would set up and inform the meeting. All matters discussed by the Committee and all materials distributed to the Committee should be treated as confidential and not circulated outside the Committee unless otherwise stated.
Industry Partnerships in APGOT Trials
For industry partnerships, there are three possible models (Figure 3). In option 1, trials are led by an academic institution and grant-funded, with the database residing at the lead institution. De-identified data might be shared with other APGOT academic groups and the industry partner that provided the drug or device for the study. Option 3 refers to industry-sponsored trials, which may also be academically initiated but are fully funded and sponsored by the industry partner. APGOT can play a key role in option 3 studies, such as protocol development, feasibility assessment, and site selection in member countries on behalf of the industry partner. Here, the industry partner might operate a database and share the data with APGOT for further evaluation. Finally, option 2 is a hybrid of the two where the study is academically led and sponsored but fully or co-financed by the industry partners. In this case, the lead academic group might operate a database and subsequently share it with the industry partner.
APGOT trial models for industry collaborations. APGOT, Asia-Pacific Gynecologic Oncology Trials Group; CRO, contract research organization; DB, database.
Currently Ongoing APGOT Trials
There is a growing number of trials with APGOT badging, and we are also actively participating in other groups’ trials.6 7 More information on the APGOT trials is available at: http://apgot.org/bbs/content.php?co_id=clinical01
As new member groups have joined, the number of proposals for new trials at the biannual APGOT meeting has increased. The APGOT continue to contribute to international and regional clinical trials through coordinating and promoting clinical trials within the Asia-Pacific region for patients with gynecologic cancers.
Liaison Between Other Groups
There are multiple well-established research groups, such as the Gynecologic Cancer InterGroup (GCIG), ENGOT in Europe, and Gynecologic Oncology Group (GOG) Foundation in the USA. The APGOT hopes to be an active participant and collaborator with these networks to improve the outcomes of patients with gynecologic cancers worldwide.
Ethics statements
Patient consent for publication
Ethics approval
Not applicable.
Acknowledgments
We would like to thank Dr Mansoor Raza Mirza, Dr Sandro Pignata from ENGOT and Dr Larry J Copeland, Dr Robert Coleman, and Dr Bradley Monk from GOG Foundation for their advice in setting up APGOT.
Footnotes
Presented at This paper was published simultaneously in the Journal of Gynecologic Oncology and International Journal of Gynecological Cancer. The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Either citation can be used when citing this article.
Contributors DT and NF drafted the manuscript, and all the authors edited, reviewed, and approved the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
© IGCS and ESGO 2023. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.