The Background
As part of its global phase III trial, a US biotechnology company required the inclusion of specific Asia Pacific countries due to the high prevalence of mycobacterium avium complex (MAC) in these countries.
A US biotechnology company engaged Novotech because of its experience in providing Infectious disease CRO services and Vaccines CRO services in Asia.
As part of its global phase III trial, a US biotechnology company required the inclusion of specific Asia Pacific countries due to the high prevalence of mycobacterium avium complex (MAC) in these countries. While mycobacteria germs are very common and most people do not become sick when exposed, MAC can result in nontuberculous mycobacterial (NTM) lung disease.
Challenge
While a US CRO was contracted to manage the European and North American arms of the trial, the sponsor and alliance partner reached out to Novotech because of its Infectious disease CRO services experience to help recruit patients from Asia Pacific countries and provide full clinical trial management CRO services.
Novotech coordinated with leading investigators to establish over 25 trial sites throughout Australia, New Zealand, South Korea, Greater China and Thailand. The trial faced unique recruitment challenges such as potential candidates being excluded due to negative sputum culture results at screening, not receiving adequate guideline-based treatment prior to screening, being too unwell or living in remote regional areas which impacted their ability to comply with study requirements, and having an infection identified as resistant to Amikacin.
Our Actions
Novotech implemented three main initiatives to expedite recruitment timelines:
- Firstly, Novotech submitted additional recruitment materials for ethics approval.
- Novotech then worked with investigators, healthcare professionals and diagnostic labs across all sites to create a second line of recruitment, allowing them to capture patients initially found ineligible due to unconfirmed cultures within six months prior, but who later presented with confirmed MAC-positive cultures.
- Thirdly, Novotech worked with local networks and physicians to provide travel reimbursements for eligible candidates and enrolled patients based in regional areas, allowing patients from previously unconsidered locations to partake in the trial.
Results
Proactive CRA activity at trial sites allowed Novotech to meet data lock deadlines ahead of time.
Novotech also managed and delivered a seamless startup to an extension study initiated by US biotechnology company at several Asia Pacific trial sites.
“Novotech’s regional insight and experience was greatly appreciated in this trial. Their in-depth knowledge of regulatory environments meant we saved time when submitting materials and their relationships with key investigators and healthcare professionals allowed us to enroll patients we would have otherwise missed. Their overall contribution helped us achieve global trial deadlines.”
Head of Clinical Development, US biotechnology company