A randomized, double blind, multicentre, multinational, placebo controlled, single parallel escalating dose safety and efficacy study of drug product
PRODUCT TYPE
Monoclonal Antibody (mAb)
THERAPEUTIC AREA
Cardiovascular disease
add-on therapy on top of standard of care in the emergency department
TRIAL
A randomized, double blind, multicentre, multinational, placebo controlled, single parallel escalating dose safety and efficacy study
29 sites in 6 European countries + US
ILIFE CONSULTING SERVICES
Clinical monitoring, clinical regulatory submission in one country, and monitoring project management
BACKGROUND
The sponsor, a biotechnology company developing a “first in-class” drug product to respond to emergency care treatment, became dissatisfied with the quality of the CRO’s deliverables following negative feedback from sites in regards to the monitoring of the study. The Sponsor also experienced a lack of proactivity and flexibility from its vendor, with site initiation delays impacting the recruitment of patients.
After a difficult dose-escalation phase, the Sponsor decided to transfer part of the clinical monitoring of the extension phase to ILife Consulting.
For this dose extension phase, the Sponsor tasked ILife Consulting with the recruitment of 70 patients in 33 sites across Europe within 8 months.
OBJECTIVES
ILife Consulting’s first objective was to rebuild a relationship with the investigators and their study teams in order to regain their trust, interest and motivation in the study, which had been lost in the initial phase of the trial.
ILife Consulting also took on the task of reassessing the sites’ feasibility in terms of recruitment potential, study procedures, facilities adequacy, resources and organization.
CHALLENGES
Buy-in from the sites study teams is key to the success of any clinical trial. To improve recruitment rate and to successfully conduct and complete this clinical trial within the aggressive timelines set by the Stakeholders, it was crucial to understand local emergency care procedures and work hand in hand with the investigator sites’ study team to regain their trust, and engagement.
This meant that only a team of experienced, dedicated and focused senior CRAs led by a seasoned project manager could measure up to the challenge and meet the Sponsor’s expectations.
SOLUTIONS
ILife Consulting quickly deployed a fully operational team of highly experienced CRAs fully trained to the study protocol. ILife Consulting also re-evaluated the feasibility of each site.
To overcome the issues previously experienced by the Sponsor, ILife Consulting proposed and implemented the following corrective actions:
Re-train the investigator sites’ study team on the specificities of the study protocol and the procedures to increase the overall quality of the clinical study and of the generated data
Review with the sites the organization of certain procedures, such as the feasibility of the PK endpoints, in order to increase the quality of the study
Communicate efficiently and proactivity with sites in order to keep them updated on the overall study progress, support them as and when required and answer any questions in a timely manner considering the trial was conducted in an emergency care environment
ILife Consulting Monitoring Project Manager was able to fill clinical project management gaps and facilitate the transition and prompt set-up of the extension phase.
ILife Consulting’s Clinical Research Associates (CRAs) were trained and fully operational in record time
Built a strong relationship between ILife Consulting Monitoring Project Manager, ILife Consulting CRAs and Investigator site study teams rapidly and efficiently regaining the momentum needed for the timely completion of this clinical trial
In less than 9 months, ILife Consulting included more patients than planned, opening less sites than originally anticipated, demonstrating ILife Consulting productivity and saving the Sponsor unnecessary costs
The study was completed within the timelines set by the Stakeholders with high-quality publishable data
RESULTS
ILife Consulting’s agility and proactivity ensured that project handover was completed within 1,5 weeks from bid defence to handover kick-off meeting. Thanks to ILife Consulting CRAs’ network, a swift and efficient CRAs’ recruitment, handover and training was achieved within a month.
ILife Consulting’s project team recruited over 100 patients exceeding the number of patients to be recruited (70). As the recruitment in the USA never materialised, this allowed ILife to complete the recruitment of the entire study with the European sites. The recruitment of over 100 patients in 9 months, with less sites than anticipated, not only meant that ILife Consulting raised to the challenge and achieved the objectives set by the Sponsor’s stakeholders, but it also demonstrated ILife Consulting productivity and cost-effectiveness, having saved the Sponsor unnecessary costs.
The greatest achievement in this rescue mission, was the interactions and relationship that ILife Consulting team managed to establish with the investigators and the sites study teams, the availability of ILife Consulting to answer rapidly and efficiently questions from the sites in an emergency care set-up, and the level of support ILife Consulting provided to the study teams throughout the trial. The flexibility and proactivity of ILife Consulting CRAs was acknowledged by all on many occasions.