An emerging biotech pharmaceutical company conducting a Phase II study, with a novel treatment for a GI indication, aimed to achieve set up in three months and enrol 120 patients in 6 months, in two sequential cohorts of 60 patients. The company partnered with Evestia Clinical (EVC) to manage these expedited timelines and requested to work with the sites they had selected, which were naïve to clinical trials.
Main Study Challenges and Evestia Clinical Solutions
Short time for study set up and site activation
The sponsor and Evestia Clinical team held the Kick Off Meeting (KOM) immediately after study award. Following this meeting, the teams met frequently each week to discuss timelines and coordinate the actions.
The Evestia Clinical project manager worked closely with the internal team and IT and all systems were up and running a few days after the KOM. The Evestia Clinical team managed the selected vendors to ensure the contracts were expedited to allow work to start. EDC and eDiaries were built in record timelines thanks to the close interactions, reviews and UATs between the teams.
Regulatory submissions were initiated by the sponsor, and site contracts negotiations were managed while the study set up was being completed.
This coordination of the study set up and sites start up activities ensured the sites were ready for activation immediately after receiving regulatory approvals. Three months after study award the sites were activated, and First Patient In was achieved in time.
Large amount of data in short time
Both the sponsor and Evestia Clinical expected enrolment to be quick, as the sites were very interested in the study and had already shared that they had a big pool of candidates prior to starting the study. However, the pace at which patients were enrolled exceeded all expectations, with 50% of the patients being enrolled in the first 6 weeks.
This extremely fast enrolment posed some risks. At the study start there were some delays in entering data, as the sites were overloaded. Also, sites were not experienced in clinical trials, and there was a need to provide continuous training and implement a very close site management and monitoring approach to ensure compliance with the protocol, GCP and data entry timelines.
The clinical study team, led by the clinical team lead and the project manager, had to change monitoring plans to increment the days on site. Flexibility and adaptability were key to allow these changes to be implemented on an ongoing basis. The study leads re-organized the clinical operations team, assigning and training additional CRAs, to be aligned with the increased need of monitoring.
Evestia Clinical data management team updated their data management plan to align with the required pace to clean data. The coordination with the clinical team was another key success factor to ensure data could be cleaned seamlessly, in a sequential manner.
Protocol deviations and queries trends were analysed by the sponsor and the Evestia Clinical team in an ongoing manner, to proactively address any issues with data.
Results
Evestia Clinical project team coordinated an expedited set up of the systems, database and vendors and had the sites activated in time. Enrolment was completed ahead of time for both cohorts. Cohort one enrolment was completed in 9.5 weeks, 3.5 weeks ahead of schedule, and cohort two achieved last patient in 10 weeks, 2 weeks ahead of schedule. The Evestia Clinical team implemented continuous site training and a flexible approach to ensure data monitoring and cleaning was kept up to date. The team’s focus on site training, quality and data integrity contributed to the most successful outcome. The database was locked in time and the statistical team seamlessly worked on the required analysis.
The company was able to use the positive preliminary analysis to support their clinical development plans. As of today, the partnership is ongoing, with a Phase IIb study in the same indication in the start-up phase and another one in a different indication planned for later in the year.
About the authors
Silvia Centenera
Silvia is a seasoned clinical research professional with over twenty-five years of experience, four in pharma and over 20 in the CRO arena. Silvia has extensive global team management and operational knowledge gained through several years of holding leadership roles within project management and clinical operations. She has been responsible for the oversight and successful delivery of clinical trials in a variety of therapeutic areas, with special focus in oncology and rare disease. She has been directly involved in the first stages of the clinical development of innovative biologicals, including monoclonal antibodies, and gene and cell therapy.
Kirstyn Warren
Kirstyn is an enthusiastic and analytical UK-based Project Manager, with 4 years of CRO project management experience, in phase I-II oncology, ophthalmology, gastroenterology, rare disease, type II diabetes, natural history and validation trials. She has led several projects and programs across Sponsor-dedicated portfolios, led her project team through client audits, and facilitated an expedited study start-up, involving a record ePRO 2-week set-up time. Kirstyn is highly organised and has a close attention to detail in her documentation, demonstrated by her achievement of the Gold Award in the PharmaTimes International Clinical Researcher of the Year Clinical Trial Administrator category. Her adaptability and dedication to delivering operational excellence are invaluable in her delivery of high-quality projects, which she considers to be essential in building and maintaining her strong client relationships.
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