98P - Operational challenges of an Asian Pacific (APAC) academic oncology clinical trial

Background

Multinational academic trials can pose complex organisational issues. We describe our experience running the phase III ASCOLT trial (NCT00565708), studying the impact of aspirin in resected high-risk colorectal cancer. This is the first large academic adjuvant trial fully conducted in the APAC region.

Methods

ASCOLT is coordinated by the National Cancer Centre Singapore and funded largely by academic grants. The trial opened in 2008 and is nearing full accrual (1480 of 1587) at 58 sites in 12 countries/regions, including 5 middle income countries. Trial conduct logistics were analysed to identify barriers and enablers.

Results

Diverse regulatory requirements necessitated >100 contracts and 49 ethics board reviews, leading to start up times of ∼6 months per site. Consent forms were translated into 13 languages. The enrolment target and period were revised in 2017, and site numbers expanded due to lower than projected accrual and event rates. Other challenges include communication and logistical barriers, patient attrition, recruitment holds due to changes in local laws and limited funding for patient visits, affecting countries where healthcare is not publicly funded. Solutions included engaging local cooperative groups (e.g. the Australasian GastroIntestinal Trials Group in Australia and New Zealand) and 6 contract research organisations to manage sites, developing processes sensitive to local needs, transition to electronic data management, and a centralised drug dispensing system. Measures to overcome disparate experience across sites and to quality control include regular contact with the central team to troubleshoot (e.g. >200 data queries are raised a month) and central and on-site monitoring. 16 sites were closed due to resource or recruitment issues. In response to the COVID-19 pandemic, strategies such as telehealth consults, direct postage of drugs to patients, consent form amendments, and rationalised recruitment and biospecimen collection were swiftly applied.

Conclusions

While ASCOLT highlights the feasibility and value of APAC academic collaborative trials, our challenges reflect the complexities in a region of cultural, linguistic, economic and regulatory diversity. An APAC academic trials consortium is suggested.

Clinical trial identification

NCT00565708.

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Centre Singapore.

Funding

National Cancer Centre Singapore.

Disclosure

All authors have declared no conflicts of interest.