DT Consulting has released its inaugural Clinical Trial Digital Tracker Survey, designed to assess industry attitudes about digital adoption by global trial sites. According to the findings, many site professionals are reluctant to integrate digital tech into their process, citing factors like cost, complexity and selecting the appropriate tech for the job as the primary barriers.
The survey was crafted to determine the number of active research sites using digital technologies, what tools are employed, which digital tech they feel delivers the best results, and the obstacles sites and sponsors must overcome in integrating digital into their traditional operating models. DT Consulting sent the survey to all global interventional studies launched from October 2019 to September 2020 (six months before the COVID-19 outbreak, and six months after); 261 sites responded.
Outsourcing-Pharma spoke with Francesca Properzi (director of research for DT Consulting) and Sudip Sinha (vice president of digital CRO with Indegene about the survey.
OSP: Could you please tell us a bit about DT Consulting—who you are, what you do, key areas of speciality, and what sets you apart from similar companies?
FP: DT Consulting, a business consulting arm of Indegene, is a specialist strategy consultancy that enables pharmaceutical firms to achieve digital excellence and a superior customer experience — an essential component of continued business success in this age of digital disruption. We help leading innovators in the pharmaceutical industry successfully assess, launch, accelerate, and optimize digital transformation initiatives.
OSP: Could you please share your overview of how adoption of digital adoption has evolved in recent years?
FP: Extensive research shows that COVID-19 accelerated the integration of digital technologies in the healthcare sector worldwide. For example, digital providers globally report that as soon as one month after the COVID-19 outbreak virtual consultations increased up to 50%. Clinical research shows similar trends.
SS: 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 and 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.
OSP: Could you please share some of the most notable findings in the survey?
FP: Our survey main results show that up to 43% of clinical trial sites do not use digital tools to support clinical trials. Of the respondents that use digital tools, the majority use digital tools for patient recruitment, while the technologies mostly used are recruitment channels and eConsent.
Our survey also shows RWD and RWE are still not used at scale by researchers as well as end-to-end virtual/patient experience platforms
OSP: Your survey indicates many sites still are reluctant to incorporate these technologies. Could you please talk about some of the reasons for their hesitation?
FP: Clinical trials organizations find that cost, complexity, and finding the right technology most challenge digital adoption. Interestingly, of the 43% of clinical trial sites that are still not using digital tools to support their studies, many commented that digital literacy and lack of access/enablement to digital technologies of their patients was the main reason for not adopting innovative tools. Equipping patients is certainly a crucial challenge.
OSP: How can sites and sponsors overcome some of the concerns/obstacles about adopting more advanced digital technologies?
FP: 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 into traditional operating models. Collaboration with other industry stakeholders, including regulators will also accelerate the digital transformation of the sector for the benefit of patients.
OSP: How helpful have the FDA and other governmental/regulatory agencies been in supporting increased digital adoption? Can you talk about some of the resources they have offered that might be informative and helpful?
FP: The U.S. Food and Drug Administration (FDA) responded quickly to the pandemic restrictions by issuing supporting policies for adoption of digital technologies applicable to clinical studies, including guidance for remote monitoring devices. However, maintaining patient safety while assuring product quality is essential and it is important for clinical trials organizations to collaborate with regulators to speed up the identification of issues requiring regulators guidance.
OSP: Do you plan on repeating the survey in the near future?
FP: We plan to launch our Clinical Trial Digital Tracker global survey every six months and publish a report with the results within a month after data collection to monitor regularly the progress of digital adoption in clinical studies.
OSP: Do you have anything to add?
FP: We would be happy to hear and get in touch with any clinical research investigator and sponsor that is dealing with digital implementation, to know more about their experience and understand what can be done to overcome the major barriers to digital technologies adoption.