Decentralised clinical trials: what biotechs need to know. By Ronen Vengosh
In response to the Covid-19 pandemic, the life sciences industry had little option but to accelerate its adoption of cloud-based and end-to-end technology solutions, and implement virtual digital trial models that would enable clinical trial processes to continue in the face of global lockdowns. Since then, decentralised clinical trials (DCTs) have continued to transform thinking where the discipline of clinical trials are concerned. Conducted remotely or through local healthcare providers, decentralised trials deliver wider access to more diverse patient populations, streamline trial processes, support a more patient-centric approach, and enable the continuous collection of richer data sets.
As regulatory authorities continue to clarify their remote and hybrid trial monitoring procedures, the evolution of decentralised clinical trials looks set to continue as study teams look to take advantage of the enhanced flexibility offered by DCTs. However, as promising as decentralised clinical trials are, there are some key things the industry will need to reckon with before it can scale successfully across therapeutic indications or global regions. That includes ensuring they have the right technology foundations and protocols in place to ensure consistent collaboration between partners and full compliance with standard operating procedures (SOPs), as well as increased data transparency and quality.
Trial design: being smart with technology
Technologies such as eConsent and ePRO can go a long way towards facilitating remote data capture, how patients participate in studies and how patient-reported outcomes are reported. But like all technological advancements, these technologies can also complicate things if not implemented and used properly. It’s not enough to simply ‘slap together’ a tech stack and hand it off to users. Organisations will need to sufficiently train stakeholders in all relevant processes and technology solutions. They will also need to ensure that these solutions are well integrated in the trial workflow, and that appropriate data security and governance controls are in place.
The remote components of clinical trials will raise questions around data management which any biotech will need to consider before pursuing DCT. For example, how will dispersed sites share content and collaborate in a secure and compliant fashion?
Alongside automating the ingestion, coordination and processing of data to one central repository (an electronic Trial Master File or eTMF), it will be important to ensure that all syncing and permissions that happen in the cloud can be easily customised, that workflows can be automated to improve data quality and integrity, and that detailed audit trails are automatically generated. Alongside accelerating the delivery of real-time insights and integrating data into one place, empowering users with the tools they’ll need to undertake real-time collaboration and data analysis from anywhere will also be a critical success factor.
Determining the right approach
DCT is new enough that researchers, patient populations and other stakeholders may have different perceptions around key characteristics and capabilities. So communicating clearly all aspects relating to the planning, operationalising and deployment of a decentralised clinical trial will be critical. That includes defining the roles and responsibilities of sponsors, study teams, investigators and patients, as well as evaluating important issues like patient safety and data integrity and security.
It's important to recognise that DCT does not necessarily mean the end of clinical trial sites or that these sites will no longer have a role. In many instances, DCT will become one of a suite of options that are available to trial participants, some of whom may prefer remote site visits rather than going to a clinic.
Similarly, not all sites will be equipped to fully transition to decentralised processes because they lack the infrastructure needed to support this shift. However, many will still be able to take advantage of a growing number of decentralisation services and technology interventions – such as the remote monitoring of vitals or mobile clinics or the delivery of trial drugs and test kits direct to patient homes.
Regulatory considerations
One of the core promises of DCT is that it facilitates enhanced patient recruitment and trial conduct across wider geographies. But without a centralised regulatory framework around DCT, this digitally enabled enlargement of trial scope and scale can potentially create new headaches. For instance, regulatory differences between the EU, US and APAC regions means while researchers may indeed find it easier to undertake the recruitment of participants from countries across multiple geographies thanks to the shift to digital, they will still need to reckon with multiple regulatory bodies.
To overcome this challenge, organisations will need to look for digital tools and platforms that will help protect data wherever it resides, and support full compliance with geography-specific regulations such as GDPR, HIPPA, CCPA and more. That means finding solutions that feature content safeguards to prevent out-of-bounds sharing along with multi-layered data governance controls that will protect privacy and assure authorised access only.
Secure cloud collaboration
Finally, today’s fast-moving and data-intensive life sciences industry is proving an all too tempting target for cyber criminals looking to steal IP and hold databases to ransom. The financial impact of any cyber breach that results in a clinical trial delay can cost companies millions of dollars a day. So when it comes to enabling the secure cloud computing environments that will accelerate research and make it possible to manage multiple complex workflow and compliance demands, organisations should be looking for file sharing and collaboration platforms that also feature built-in ransomware detection and file recovery services to gain the protection that’s needed should a breach occur.
Ronen Vengosh is VP of Life Sciences at Egnyte
