Evidence map›Paper›PMID 37364220›Full record

ArticleJCO global oncology2023

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

Daphne Day, Han Chong Toh, Raghib Ali, Estelle Mei Jye Foo, John Simes, John Whay Kuang Chia, Eva Segelov, ASCOLT Investigators

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JCO global oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00565708 (Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00565708 phase3unknown statusnot on this map

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

TypeinterventionalSponsorNational Cancer Centre, SingaporeRan2008 to 2024Enrolled1,587ConditionsColorectal CancerArmsplacebo, Acetylsalicylic acid
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 4 countries.

Daphne DayFaculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.ORCID 0000-0001-8262-2441
Han Chong TohDivision of Medical Oncology, National Cancer Centre Singapore, Singapore.
Raghib AliPublic Health Research Centre, New York University, Abu Dhabi, United Arab Emirates.
Estelle Mei Jye FooDivision of Medical Oncology, National Cancer Centre Singapore, Singapore.ORCID 0000-0002-4957-3825
John SimesUniversity of Sydney NHMRC Clinical Trials Centre, Sydney, NSW, Australia.
John Whay Kuang ChiaDivision of Medical Oncology, National Cancer Centre Singapore, Singapore.
Eva SegelovFaculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.ORCID 0000-0002-4410-6144
ASCOLT Investigators
National Cancer Centre Singapore · SGUniversity of Bern · CHMonash Health · AUNew York University Abu Dhabi · AEThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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.

methodsWe 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.

resultsChallenges 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.

conclusionTo 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.

Indexed as

Colorectal NeoplasmsCOVID-19AsiaAspirinHumansPandemicsAspirin

Identifiers

PMID37364220
PMCPMC10497275
OpenAlexW4382132864

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.