ICON partnered with a drug development sponsor to conduct a global study for Major Depressive Disease (MDD) in over 600 adult subjects.

This Major Depressive Disease (MDD) adult study presented the following three main challenges:

1. The Protocol required the use of the Effort Expenditure for Rewards Task (EEfRT) with monetary reward to subjects. This tool had never been used in clinical trials and we expected study rejection in multiple countries due to subject reward managed via Mastercard. The tool was validated to measure anhedonia symptoms in depressed patients.
2. IMP expiry date did not allow study delay because sponsor did not plan to assume extra cost to manufacture new IMP supplies. Due to limited number of IMP, sponsor required to prevent IMP shipment to non-recruiting sites and to hit the LPLV milestone on time.
3. Database lock (DBL) with 600 randomised subjects in 85 sites had to be completed within five business days after last Patient, last Visit (LPLV).

To minimise the risks to meeting recruitment timelines, ICON implemented a site back-up strategy with competitive site activation. ICON submitted the study in EU countries with all sites designated as main. In case of study approval, all sites were planned for initiation in EU. Among initiated sites, only sites which proved subject was ready for screening were planned for activation and IMP shipment. As soon as the required number of 85 active sites was reached, activation was to stop and initiated sites without screening became ‘back-up’ in the event that ICON needed to increase recruitment. In LATAM, ICON prepared the submission package to submit as needed to replace any dropping countries and sites in EU.

Study was not approved in three EU countries (France, Croatia and Belgium), but not due to the EEfRT assessment. Lost countries were replaced with submitted and approved countries in LATAM (Argentina and Mexico).

Enrollment began during the first wave of the COVID-19 pandemic. Due to ICON’s competitive activation strategy, sites not heavily impacted by COVID-19 could be activated which allowed recruitment to begin. Competitive enrollment in sites encouraged recruitment and it was controlled by country randomisation caps to prevent lack of IMP. Compensation for subject travel costs was included in investigator contracts and the use of a subject travel vendor from the beginning of the study eliminated the wide use of subject remote visits during COVID-19 as patients were able to reach sites in secure manner.