Company insight
Decentralised clinical trials oversight management
Lumis Life Science Consulting, a subsidiary of Lumis International, provides consulting and solutions to biopharmaceutical and medical device companies. The company’s services cover vendor selection and management, clinical trial oversight management and training.
he concepts around decentralised or virtual clinical trials have been extensively developed over the past few years. Especially with the start of the Covid-19 pandemic, companies have been faced with new challenges to keep the patients in their ongoing clinical trials or recruit new patients. Regulatory authorities adjusted quickly to support new approaches to clinical trials and the concepts of decentralised clinical trials experienced a large upswing. The challenge the sponsors are facing is to continue with existing protocols and adapt them to meet the patient needs under the new circumstances – to get patients into clinical trials wherever they are. With the technical solutions that were already developed, for example, e-consent and all the tools summarised as electronic Clinical Outcomes Assessments (eCOAs), a shift in paradigm needs to take place. However, this shift had to take place with all stakeholders involved in the clinical trial. Understanding the patient journey became even more important and change was also required in clinical trial management. The needs of the patient is the focus of attention to ensure participant retention and an increasing protocol compliance. The clinical sites have to be trained to meet the needs of a remote site and adjust their processes by implementing new technologies, such as telehealthcare or remote patient monitoring, to ensure close contact with the patient without on-site visits.
T Vendor innovations
The vendors are at the forefront of the technical inventions. For the majority of sponsors, the concepts and implementation of decentralised clinical trials was to start navigating with uncertainties. They have to
Clinical Trials Insight /
www.worldpharmaceuticals.net
undergo a change of management processes from the traditional clinical trial performance to virtual or hybrid clinical trial concepts with a patient-centric approach. The vendor selection process is also facing new challenges as new different stakeholders with new technical solutions have to be assessed. According to ICH E6 (R2), the sponsor has to validate the technical solutions not only of the CRO but also of their subcontractors. Therefore, it should be considered during the vendor selection process whether to go with single or multiple providers, which also has an effect on the resources to oversee the outsourced activities.
journey and site compliance throughout the study, the proactive approach of early involvement of the stakeholders can hardly be denied.
A new approach
Although start up time might take longer, it will pay off during the conduct of the study with a higher engagement of patients and sites. With this new approach, patient training and education is paramount at the early stage of the clinical trial. The tools to be used for vendor management and clinical trial oversight will be similar. The need to perform an early and continuous joint risk assessment
“With the change in operational activities and new process integrations, the acceleration of timelines for clinical trials and the increasing data completeness should lead to a shorter time to market.”
The risk assessment needs to include an additional security risk assessment, especially cyberthreat protection during remote monitoring controls. When talking at a recent conference about decentralised clinical trials, some participants expressed the need for an extended start-up phase involving all stakeholders to prepare the protocol, integrate the technical solutions and exchange with regulatory authorities as early as possible. The data flow and communication throughout the clinical trial should be mapped proactively as well as the management of the data flow. Early involvement of the CROS and vendors before protocol finalisation is another shift in paradigm for the vendor selection process and planning of the clinical trial. With the goal to ensure a feasible patient
with the CRO, a well-thought-out governance charter or communication plan, just to name a few, will remain. What will change will be the increased sponsor- stakeholder-relationship and management at the early planning stage of a clinical trial or clinical development. With the change in operational activities and new process integrations, the acceleration of timelines for clinical trials and the increasing data completeness should lead to a shorter time to market with high quality data. The very early development of a good relationship with all vendors should lead to integrated teams striving for a common goal: to reach definitive, conclusive results that move the sponsor company to the next development stage. ●
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