By Lily Borisov and John Ferraro, Halloran Consulting Group, Inc.
Almost everything we do in our daily lives is technology focused – from communication to navigation to learning. Most industries have recognized how technology increases efficiency and flexibility and are now embracing it in an even more personalized way. It is time for the biotech industry to embrace technology in a similar way. Virtual trials are a part of this growing tech world and have been a topic of discussion for a while now, so why have we not yet implemented them more widely for clinical trials? Is it because we are overwhelmed or unaware of the technology options? Afraid clinical sites or participants will not accept this as an option? Or that our virtual trials will not be run with the same rigor as traditional trials? With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must. The slow uptake of virtual trials has become a thing of the past, as biotech and pharma companies alike scramble to take parts of their trials out of the clinic and into a virtual setting.
Giving participants the flexibility to take part in a trial from the convenience of their own home transforms clinical trials into a patient-centric design and, in the end, potentially improves overall safety and compliance. With COVID-19, it is more important than ever to implement the technology to continue producing new therapies and advancing healthcare, while, keeping study participants safe.
Virtual And Home Health Visits
As clinical sites allow participants to be seen for visits, they will likely be much more vigilant about visitors and more open to study participants attending their scheduled visits virtually rather than in person. Participants may also look to forgo attending their on-site visits due to doubts surrounding COVID-19. This might cause out-of-window visits to occur, leading to even more protocol deviations and, ultimately, an impact on data integrity.
There are a multitude of solutions and tools available to mitigate these risks. One option is to take a decentralized clinical trial (DCT) approach. A DCT allows the trial to be conducted in the convenience of the participant’s home. In-person site visits can be replaced with telemedicine or home health visits, depending on the needs of the study – using home health visits in instances where sample collections, administration of the study drug, monitoring of vital signs, or diagnostic procedures are required and telemedicine in instances where they are not.
Electronic patient reported outcomes (ePROs) can also be used when participants may need to answer a health questionnaire. Many health screening questionnaires can be answered directly by participants using a validated, self-reported ePRO as opposed to having a healthcare provider administer the questionnaire. For example, healthcare providers will screen disease activity for lupus participants using items from the Systemic Lupus Activity Measure (SLAM), which can be replaced by a self-reported version called a Systemic Lupus Activity Questionnaire (SLAQ). If ePROs are being utilized, source data validation during monitoring visits is reduced or eliminated altogether, since the ePRO now becomes the source.
Video conferencing can be applied if there is no validated, self-reported version of the questionnaire or in addition to the online questionnaires. Companies such as Zoom offer healthcare video conferencing options. In these instances, participants may need devices to be available for those who may not want to use their own or do not have the appropriate devices.
Digital devices are also being leveraged to support virtual data collection across a multitude of areas, including but not limited to monitoring of vitals, symptoms, study drug compliance, safety events, and two-way communication platforms. These digital platforms should be closely examined as possibilities to overcome the transformation to truly virtual trials.
One major concern when going remote is the possibility of study compliance decreasing. If the virtual trial is appropriately set up and conducted, it is possible for compliance to increase in a virtual trial over that of a traditional setting. Participants from the RASS clinical trial were asked about what they perceive as being barriers to study participation, and among the top barriers reported were having to miss work and difficulty accessing the study location. Conducting virtual trials alleviates these burdens by bringing the visit to the participant’s own home.
Using phone and text notifications is a great way to ensure compliance is achieved in virtual trials. A simple welcome or wellness check call to participants from site staff can help remind participants of their involvement in a study and therefore improve compliance. This can also make participants feel like their contribution matters and increase their sense of belonging in the trial, helping to build a sense of community. Many eSource vendors can set up auto reminders to participants either directly as a notification from their study app or as an email, further streamlining the communication.
The value of virtual clinical trials has come to the spotlight and they are now seen as a vital solution to avoid halting advancements in therapeutic drug development. While there are many benefits to using virtual trials, sponsors should keep in mind the implications that can also arise.
Participant safety is the most important consideration when conducting a clinical trial. In virtual trials, it is essential to ensure that the technology being used has safeguards in place to protect participants’ personal information. Examples of these safeguards include using a HIPAA compliant system, or a system that utilizes encryption of data, and having tight procedural controls on the process by which virtual visits are performed.
Another consideration when conducting virtual trials is understanding which participants are willing to use virtual platforms and have access to the internet and the appropriate technology. People with access who are willing to use technology may tend to have a higher socioeconomic status or be younger in age. If your trial starts experiencing dropout due to this virtual shift, your study population may not accurately represent the true disease population, leading to biased results.
Lastly, user experience should always be kept in mind when designing a virtual trial. This will require rigorous quality control checks prior to releasing the service to participants. The platform should be flawless, with a simple user-friendly design, to ensure compliance in use.
We live in a technology-driven world in our personal day-to-day lives. With the emergence of COVID-19, we, as an industry, should take this time to innovate and adopt this technology to continue enabling clinical research. By keeping the needs of the patient in mind and engaging our study participants as not just patients in a trial but also understanding the impact of their condition and treatments on their daily lives, successful virtual trials can be accomplished. Therefore, we should be embracing these patient-centered approaches and assessing the options for accomplishing more virtual trials.
About The Authors:
Lily Borisov, a consultant at Halloran Consulting Group, has clinical trial experience in diagnostic development and has developed skills in clinical trial design, quality, project management, literature reviews, EDC, database management, and data analysis using SAS. Her responsibilities include establishing project timelines, supporting subject matter experts on specific projects, identifying opportunities for project expansion, and assisting with devising support strategy. Previously, Borisov worked as a senior clinical research coordinator at a biotechnology start-up, where she was involved in both study start-up and conduct. In this role, she worked interdepartmentally and used helped develop tools, systems, and workflows to drive optimal clinical trial execution.
John Ferraro, principle consultant at Halloran Consulting Group, has more than 28 years of experience in clinical operations/research within the biotechnology and pharmaceutical industry. During this time, he has been successful in all sizes and types of organizations as well as in a myriad of therapeutic areas, most recently oncology, hematology, immuno-oncology, and rare disease. Ferraro is a clinical operations leader who excels at operational strategic planning, oversight, and delivery of clinical development programs. Prior to joining Halloran, he led his own consulting firm, JnC Clinical, where he was engaged with various organization types as VP of clinical operations or clinical advisor.