The concepts around decentralised or virtual clinical trials have been extensively developed over the last 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 even to recruit new patients for the studies. Regulatory authorities adjusted quickly to support new approaches to clinical trials and the concepts of decentralised clinical trials experienced a large upswing.
Meet patients in the comfort of their own homes
The challenge for the sponsors is to continue with the existing protocols and to adapt them to meet the patient needs under the new circumstances – to get patients into clinical trials wherever they are and not as the patients were used to at the clinical trial sites. With the technical solutions which were already developed e.g. e-consent and all the tools summarized as electronic Clinical Outcomes Assessments (eCOAs), a shift in paradigm has to take place.
However, this shift had to take place with all stakeholders involved in the clinical trial. Understanding the patient journey within the clinical trials became even more important and change was also required in the management of the clinical trial. The needs of the patient have 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 to adjust their processes by implementing new technologies such as tele-healthcare or remote patient monitoring to ensure a close contact to the patient without on-site visits.
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 undergo a change management process from the traditional clinical trial performance to virtual or hybrid clinical trial concepts with a patient centric approach.
The vendor selection process is 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 a single or multiple provider, which also has an effect on the resources to oversee the outsourced activities. The risk assessment needs to include an additional security risk assessment especially cyberthreat protection during remote monitoring controls.
Reassess the startup phase
When talking at a recent conference about decentralised clinical trials some participants expressed the need for an extended startup phase involving all stakeholders to prepare the protocol, to 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 finalization is another shift in paradigm for the vendor selection process and planning of the clinical trial. With the goal to ensure a feasible patient journey and site compliance throughout the study the pro-active approach of early involvement of the stakeholders can hardly be denied.
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 CRO, a well thought through governance charter or communication plan, just to name a few will remain. What will change will be the increased sponsor-stakeholder-relationship and management already at the early planning stage of a clinical trial or clinical development. With the change in operational activities at the sponsor and new process integrations into their own organization 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.
(The article first appeared in Clinical Trials Insight December 2021 issue)