How can central labs increase investigator satisfaction?
By World Courier
The performance of a central lab can make or break a clinical trial, with investigators opting in or out of a study depending on their perceived experience of it.
Up to 61% of principal investigators (PI) state the central laboratory selected by sponsor would affect their success and their willingness to work with a sponsor on future studies1. In addition, 51% say they are more satisfied and willing to work with a sponsor when they have selected their preferred central lab from past clinical trials2, according to a study conducted between May and July 2019 by the Life Science Strategy Group (LSSG) to 260+ physicians.
As the complexity of trials increase and different studies start recruiting concurrently from the same patient population, attracting the best investigator sites becomes key to meet recruitment and retention goals in the timeframe specified by the sponsor. So how can central labs ensure they enter the investigators’ — and as a result the sponsors’ — list of preferred labs?
What are the sponsors' requirements? What matters to investigators?
Depending on the study protocol, clinical trials require different lab tests, and the sponsors or CRO may work with local labs or central labs. These include tests to:
- Establish inclusion and exclusion criteria
- Monitor the safety of the patients enrolled
- Demonstrate the efficacy of the investigational product
When a study chooses a central lab, it is usually because investigators value consistency and patient centricity. This is why sponsors often look for long-term solutions which will provide a one-stop shop for all their laboratory development needs, with features like the use of similar analytical methods, avoiding bias when processing samples, as well as same day collection so that patients don’t need to travel. Sponsors value performance, consistency and reliability, as well as end-to-end visibility and 24/7 support available so that investigators can focus on what really matters to them, the patients.
Temperature control
To ensure stability, most samples must be maintained within a strict temperature range. If a sample is received outside of stability, it will be rejected as the data will be deemed inaccurate. Once samples are extracted, the timing of the transport and storage between the collection and laboratory analysis needs to follow specific standard operating procedures to ensure consistency and compliance with process.Patient centricity
Enhancing patient experience within a trial is rapidly becoming the industry standard. Not only does it help improve compliance, recruitment and retention as well as quality of data, it also helps to manage costs.
There are many hidden costs of a non-patient centric approach, from repeated visits to sites implying the need to travel and book time off, to the risk of excursion resulting in kit wastage and forcing patients to get redrawn which can lead to dissatisfaction and potentially cause them to drop out of the trial. Processes need to be patient-friendly, samples need to be processed rapidly and results should be delivered on-time to meet stringent windows.
As tests and procedures become more complex, making a real difference in improving and harmonizing patient experience from a lab perspective will be key to attract patients from different locations and thus, increase investigators’ satisfaction.
Speed and performance
33% of the investigators surveyed by LSSG mentioned that meeting sponsors’ timelines is one of the most difficult challenges they face3. So the provision of on-time services, even under the most challenging circumstances, is required. Flexibility, agility and expertise are critical to mitigate risk and ensure a timely trial implementation from patient enrollment to the analysis of the results and the testing of sample.
Expertise in time- and temperature-critical logistics is a valued asset for investigators, as it gives them the reassurance that their precious samples will be safe at all times and logistics incidents won’t delay their research.
Communication and end to end visibility
The high value of all clinical trial shipments – because of the impact it has on the research itself – pushes sponsors and investigators to favour visibility, transparency and proactive communication. It is high-priority for them to be able to track their samples throughout the supply chain. They need to know where those are, whether the quality might have been compromised, what data they have access to and what consent they have obtained from the participants.
Visibility, transparency and communication will help solve issues before they even arise.
Cost
As drug development costs and complexity increase, sponsors continue to be under immense pressure to cut spending. The right mix of strategies is needed to meet the expectations of diverse stakeholders such as regulatory agencies, the medical community, insurers and the public at large, without jeopardizing the quality of a trial’s data.
Delaying approval will cost hundreds of thousands of dollars, even for a day. Significant cost savings can be obtained by reducing wastage and by minimizing delays and extra enrollment time, which ultimately affect the drug development and total duration of the study.
How to keep investigators – and sponsors – happy?
It is essential for sponsors to attract the best investigator sites to participate to their trials but, as we mentioned, investigators express strong preferences when it comes to central labs, which can greatly influence the decision-making. Central labs need to empower investigators with high-quality and consistent yet flexible solutions, allowing them to enhance patient experience and streamline costs. But everything starts with selecting the right partner.
- Expectation alignment: Ensuring investigators and sponsors’ expectations match is key. A flexible approach will make it possible to tailor logistics to the central lab and the investigator needs. Some shipments are time- and temperature-critical and require premium services with the use of specialist packaging. Others don’t.
- Logistics model: There are different options – including NFO and a hybrid model, with a choice made dependent on quality and cost requirements. And whichever approach is selected, service excellence should never be in question.
A flexible approach will also help meet recruitment and retention goals by adapting collection times to the patients and protocol needs so the overall process becomes best-in-class.
In addition, the monitoring and support offered by a dedicated logistics team available 24/7/365 with a global courier network will highly enhance the investigator experience. Real-time communication will allow for rapid intervention when needed and the ability to connect sites worldwide into the central lab.
Finally, the right partner should do its best to prevent the escalation of costs. Tactics like keeping a carrier agnostic approach in order to get more flexibility during the route selection process helps keep costs low for the central lab. And a high-quality service will reduce the risk of excursions or vanished shipments, which both entail a loss of time and money, whether we’re dealing with the direct cost of building, shipping and transporting kits or testing samples, the indirect cost of resupplying and reshipping the material or the opportunity cost of having teams tied up with chasing the courier, analysing the excursion and redoing the work.
Summary
In conclusion, selecting the right partner early in the process will help bring peace of mind to investigators and sponsors when they select the central lab for their next trial.
From our dedicated Laboratory Logistics Control Tower team to our hybrid and premium solutions aiming at giving you flexibility and end-to-end visibility in a lower-cost package, World Courier can help you strengthen your reputation as a leading central lab.
Discover our laboratory logistics solutions and learn more about the flexibility of service we can offer to central labs while maintaining the World Courier quality at all time.
1,2,3 Getting investigators onboard, Covance by Labcorp, October 2019 based on the Investigator Satisfaction Report by Life Science Strategy Group, 2019
