Dataset Information

Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial.

ABSTRACT:

Purpose

The Asia-Pacific (APAC) region is a major focus for multinational clinical trials, although its cultural, linguistic, economic, and regulatory diversity pose significant challenges for trial conduct, particularly for academic clinical trials.

Methods

We describe our experience running the investigator-initiated phase III randomized, fully accrued, Aspirin for Dukes C and high-risk Dukes B Colorectal cancer trial (ASCOLT, ClinicalTrials.gov identifier: NCT00565708, N = 1,587), studying the benefit of aspirin in resected high-risk colorectal cancer. ASCOLT opened in 2008 and is the first large academic adjuvant trial fully conducted in the APAC region. Centrally coordinated by the Trial Management Team at the National Cancer Centre Singapore, it has involved 74 sites across 12 APAC countries/regions, including five middle-income countries.

Results

Challenges encountered included regulatory complexity, communication and logistical barriers, limited funding and resources, disparate experience and infrastructure across sites, recruitment holds because of changes in local laws, patient attrition, and disruptions caused by the COVID-19 pandemic. Over 100 contracts and 49 ethics board reviews were required, contributing to a lengthy prestudy preparation time of 2 years and start-up times of approximately 6 months per site. Some of the mitigating actions included engaging local cooperative groups (eg, the Australasian Gastro-Intestinal Trials Group in Australia and New Zealand) and seven contract research organizations to manage sites, regular communication with the central team, transition to electronic data management, and a centralized drug-dispensing system.

Conclusion

To ensure an efficient and patient-centered clinical trials environment in the APAC region and sustained growth, we suggest coordinated approaches to harmonize regulatory processes, APAC academic oncology trials consortia to streamline processes and provide governance, and ongoing commitment from governments, funding agents, and industry.

SUBMITTER: Day D

PROVIDER: S-EPMC10497275 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial.

Day Daphne D Toh Han Chong HC Ali Raghib R Foo Estelle Mei Jye EMJ Simes John J Chia John Whay Kuang JWK Segelov Eva E

JCO global oncology 20230601

<h4>Purpose</h4>The Asia-Pacific (APAC) region is a major focus for multinational clinical trials, although its cultural, linguistic, economic, and regulatory diversity pose significant challenges for trial conduct, particularly for academic clinical trials.<h4>Methods</h4>We describe our experience running the investigator-initiated phase III randomized, fully accrued, Aspirin for Dukes C and high-risk Dukes B Colorectal cancer trial (ASCOLT, ClinicalTrials.gov identifier: NCT00565708, N = 1,58 ...[more]

PMID: 37364220

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Project description:Background and aimsTo improve upon the estimation of 10-year cardiovascular disease (CVD) event risk for individuals without prior CVD or diabetes mellitus in the Asia-Pacific region by systematic recalibration of the SCORE2 risk algorithm.MethodsThe sex-specific and competing risk-adjusted SCORE2 algorithms were systematically recalibrated to reflect CVD incidence observed in four Asia-Pacific risk regions, defined according to country-level World Health Organization age- and sex-standardized CVD mortality rates. Using the same approach as applied for the original SCORE2 models, recalibration to each risk region was completed using expected CVD incidence and risk factor distributions from each region.ResultsRisk region-specific CVD incidence was estimated using CVD mortality and incidence data on 8 405 574 individuals (556 421 CVD events). For external validation, data from 9 560 266 individuals without previous CVD or diabetes were analysed in 13 prospective studies from 12 countries (350 550 incident CVD events). The pooled C-index of the SCORE2 Asia-Pacific algorithms in the external validation datasets was .710 [95% confidence interval (CI) .677-.744]. Cohort-specific C-indices ranged from .605 (95% CI .597-.613) to .840 (95% CI .771-.909). Estimated CVD risk varied several-fold across Asia-Pacific risk regions. For example, the estimated 10-year CVD risk for a 50-year-old non-smoker, with a systolic blood pressure of 140 mmHg, total cholesterol of 5.5 mmol/L, and high-density lipoprotein cholesterol of 1.3 mmol/L, ranged from 7% for men in low-risk countries to 14% for men in very-high-risk countries, and from 3% for women in low-risk countries to 13% for women in very-high-risk countries.ConclusionsThe SCORE2 Asia-Pacific algorithms have been calibrated to estimate 10-year risk of CVD for apparently healthy people in Asia and Oceania, thereby enhancing the identification of individuals at higher risk of developing CVD across the Asia-Pacific region.

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Dataset Information

Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial.

Purpose

Methods

Results

Conclusion

Publications

Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial.

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