Francesca Properzi and Sudip Sinha talk about how the results of an inaugural Clinical Trial Digital Tracker Survey indicate that many clinical trials organizations are still reluctant to integrate digital technologies into their processes.
COVID-19 is making virtual and decentralized approaches to clinical trials more of a necessity. The pandemic interrupted or halted 80% of trials unrelated to COVID-19. In response, FDA issued guidelines calling on sponsors and researchers to determine whether it would be best for study participants to continue in a trial or not and encouraging the adoption of virtual approaches.
To understand the state of digital adoption in industry-funded clinical trials, DT Consulting, along with Indegene, developed the Clinical Trial Digital Tracker to monitor research sites actively using digital technologies, the digital tools they're adopting, and the challenges companies face in integrating digital into their traditional operating models. Francesca Properzi, Director, Research, DT Consulting, and Sudip Sinha, Vice President, Digital CRO, Indegene, talk to Pharm Exec about how the results of an inaugural Clinical Trial Digital Tracker Survey indicate that many trial sites are still reluctant to integrate digital technologies into their processes and that cost, complexity, and finding the right technologies are the main barriers to digital adoption.
Francesca Properzi: FDA defines decentralized clinical trials as those executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model. Decentralized clinical trials are conducted remotely, with patient subjects remaining at home during a significant portion, or all, of the study. While decentralized trials are hybrid trials using largely telemedicine/remote approaches, virtual trials are conducted entirely in a remote manner.
Sudip Sinha: The concept of decentralized trial management has come to the fore after the COVID pandemic scenario impacted recruitment rates for different multicentric global trials across the clinical research industry. Different pharma/biotech sponsor companies managed trials through their subsidiaries using remote monitoring and enabling wider access to diverse patient populations, designing effective protocols based on local/regional requirements & facilitated the process of best patient management seamlessly collaborating with sites allowing study medication resupplies dispatched to the patients within the site visit window and minimizing safety concerns for patients having to visit sites unnecessarily. Using a virtual clinical trial design, companies can offer multitherapeutic area hospital sites additional study opportunities using AI/ML predictive analytics & reduce dropout rates due to remote patient engagement options. Based on the patient recruitment projects conducted by Indegene, we are well poised to improve the overall study experience for patients and sponsors.
Definitions of decentralized or virtual clinical trials remain the same and do not vary from region to region, but solutions on offer may be different from company to company.
Francesca: Our survey results show that clinical trials organizations find that cost, complexity, and finding the right technology most challenge digital adoption. Interestingly, at least 43% of clinical trials are still not using digital tools to support their studies. Few respondents commented that their patients' digital literacy and lack of access/enablement to digital technologies was the main reason for not adopting innovative tools.
Sudip: The embrace of digital technology is being welcomed strongly after the COVID pandemic. Sponsors now want to go for a decentralized clinical trial approach for higher degree of patient retention and protocol compliance. The traditional clinical trial approach does not allow for remote monitoring or allow for patient safety management without physically visiting sites. Patients would rather choose to withdraw consent and drop out midway through the study rather than face the risk of secondary infection or attain COVID positive status by coming to sites to collect investigational drug. The digital technology deployment across sites doesn't vary too much and is not differently perceived for specific therapy areas. Cold chain management for vaccine studies may need to be reviewed separately as maintaining adequate temperature conditions in a patient's home setting could be a challenge for certain patient populations located at a distance from the trial site.
Francesca: When we asked which digital tools companies were using or planning to use to conduct their trial, 22% mentioned recruitment channels and 14% eConsent and digital documents. The primary digital recruitment channels that respondents use are social media, websites, and emails.
Francesca: Only 4% reported using real-world data or real-world evidence. Virtual trial platforms, relationship management portals, and patient experience platforms also had low adoption (5% to 6%).
Francesca: When asked about adoption challenges, 9% of respondents mentioned a lack of clarity around regulations. There is a need of clear and more granular guidance around specific technology adoption and usage especially in support of patient data privacy and safety. Collaboration with regulators and other peer organizations and sharing concerns and barriers can speed up the adoption of digital tools.
Francesca: It will be more than reducing reluctance, it will be a necessity. Health authorities' responses to COVID-19 pandemic have made clear that digital technology will be more and more necessary for running clinical studies. For example, FDA issued guidelines advising the interruption of trials requiring hospital visits. As a result, 80% of trials were interrupted or halted. These events will certainly lead to an acceleration and amplification of decentralized approaches.
Francesca: First, pharma firms should encourage a shift in mindset toward digital approaches, which are still not applied at scale in clinical research. Second, it is important to define clear KPIs when integrating new innovative approaches. Also, as we discussed previously, we think that collaborating with other industry stakeholders, including regulators will accelerate the digital transformation of the sector for the benefit of patients.
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