Articles
Delivering on promises is non-negotiable
Unfortunately though, globally study milestones are often missed, leading to delays in progress - impacting on patients, and the sponsor’s ability to finance costly clinical trials.
Tufts Centre For the Study of Drug Development reports the average time to conduct clinical studies has increased by nearly seven months from 2008 -13 to 2014 -18 (Tufts CSDD Impact Report July 2020).
When a Boston-based biotech company needed to achieve their first patient dosing in record time – just one month – they partnered with Optimal Clinical Trials who produced rapid results with quality data at the fore. Investor expectations and reaching definitive milestones were intrinsically linked to this study, which was centred on a novel investigational product for a neurological condition.
The Challenge
Even as a private research centre that prides itself on rapid start up and achieving first patient in promptly, the timelines on this study meant Optimal had to rapidly establish a specialist team, as well as plan and problem solve in a time pressured environment.
The key to the study was establishing a study team with appropriate specialist expertise, proactive project management and contingency
planning, and of course, ensuring a suitable patient and follow up patients were identified in case of screen failure.
Key Requirements
- Rapid site start up
- Specialist team of investigators and procedural experts
- Dosing of first subject
- Novel CSF processing
The solution
The study required a focused team effort, drawing on expertise from our project management, clinical, nursing and laboratory teams, as well as close collaboration with the central lab partners, medical couriers, CRO and sponsor.
Because the study demanded such a rapid start up we worked outside of clinic hours; initiating project meetings with both CRO and sponsor to ensure real time decision making, and clear communication across the multi disciplinary study team. We screened patients and conducted study visits on weekends to ensure the sponsor’s deadline was met.
We established process flow time lines, contingency scenarios and solutions, and kept clear lines of reporting open.
“It was hugely important that we didn’t block any doors – we needed to work proficiently right from the beginning. Everything from the minutes of travel time for drugs to arrive at the pharmacy, to dispatching of lab samples, and calculating transit, and lead time for results– every facet was carefully considered and factored in.”
Dr Claudette Lionnet, Operations Manager, Optimal Clinical Trials
Key Deliverables
- Specialist team of neurologist and anaesthetist/emergency physicians
- Identify, screen, and dose first subject within 3 weeks – requiring 3 visits
- Facilitating, understanding and mitigating time pressure points across CRO, sponsor and site
- New laboratory processing stream for CSF samples
The outcome
The sponsor was delighted to be able to report to investors their clinical program was on track, providing reassurance to the market.
The sponsor was impressed by the responsiveness and adaptability of our team, and the ability to anticipate, navigate and resolve issues that could have derailed the delivery of this vital milestone.
Key Achievements
- First patient in the world dosed safely and within sponsors timeframe
- On budget delivery of study
- New laboratory processing capability
- Recommendations to enhance future trials to promote efficient start up
“We presented the Optimal team with an almost impossible timeframe, and we couldn’t be happier with how they performed. We had worked with Optimal on previous clinical trials, and had been impressed by their professionalism and dedication to getting the job done. When we needed a partner who was responsive, flexible, and committed, Optimal Clinical Trials was the obvious choice. Their proactivity, quality and delivery on their promises will keep us coming back!”
- Boston Biotech