As the COVID-19 pandemic halted many in-person clinical trial visits, sponsors were faced with difficult decisions about whether to delay, cancel, or modify their on-going clinical trials. One option for some trials was to replace in-person visits with remote or virtual visits. Here, we will share VeraSci’s experience helping one of our sponsors with the transition to remote visits during the pandemic.
The trial in question was a large, global, phase II trial in schizophrenia. The pandemic related lockdown began about two years into the trial and dramatically impacted the ability to conduct in-person assessments at numerous sites. One of the key assessments used in the trial was the Brief Assessment of Cognition (BAC). The BAC is a performance-based outcome measure typically administered on a tablet by a rater during a patient’s visit to the clinic. The challenge was to develop a method of remote administration to be used during the pandemic.
Considerations at Multiple Levels
Making the switch to remote visits was a time-sensitive, multifaceted problem. Chief among our concerns was whether the assessment could be performed in a way that maintained scientific integrity. It was important to ascertain whether conducting the assessment through a telehealth visit would preserve the validity of the test. Regulatory considerations were equally important, however, and regulatory guidelines were emerging and evolving rapidly at the time. VeraSci was in close contact with regulatory agencies, and Dr. Rich Keefe, VeraSci CEO, was closely involved in the organization of the International Society of CNS Clinical Trials (ISCTM) Working Group meetings used to disseminate information about remote assessments from FDA and EMA to industry. We worked closely with Dr. Luca Pani, VeraSci VP of Regulatory Strategy & Market Access Innovation, to make sure our plans were as aligned as possible with emerging regulatory guidelines. There also were important data privacy and security considerations. It was essential to select solutions that met data privacy and security requirements, as well as ensuring patients’ privacy needs were being met. Finally, there was an array of practical concerns that needed to be addressed, such as technology, connectivity, training, testing materials, and data management.
Modifying the BAC for Remote Administration
Preparing the BAC for remote administration required a subtest-by-subtest consideration of what could be done in a way that was both practical and scientifically valid. Some of the biggest challenges were the Symbol Coding and Token Motor tasks, which required the use of a touchscreen. We considered several options for implementing these two tasks but ultimately decided to eliminate those subtests to meet the timeline requirements. We determined that the remainder of the subtests could be administered remotely with modifications. Using a telehealth format that incorporates videoconferencing technology was vital because it allowed the rater to monitor the patient’s environment and behavior during testing. Importantly, the modified assessment still enables the rater to compute a valid composite score.
BAC Remote Administration Deployment
The first step in deploying the BAC for remote administration was to develop the materials and procedures needed. This included developing a rater training process, developing technical support procedures, creating an administration manual, and modifying data entry procedures as well as identifying, qualifying, and procuring a secure platform for videoconferencing.
Remote Administration Deployment Process
The next step in deployment was rater training. This involved identifying the sites and raters that needed to perform remote administration of the BAC, distributing necessary materials to conduct the assessment, and distributing telehealth platform credentials.
Finally, as we began rolling out remote administration, we took a number of steps to make sure everything went smoothly. We provided on-going rater and technical support, conducted rater debriefing calls, supplied full data review with feedback to raters, and we evaluated rater and patient surveys. We used all the information we collected as feedback to refine our processes.
As this study is currently on-going, we have been collecting formal and informal feedback from raters and patients. Overall, the responses have been very positive. Patients and raters have appreciated feeling safe while still doing the assessments. Knowing that we are concerned about their safety has led to an increased sense of engagement. We have not had anyone express privacy concerns. We have had some feedback from raters that there is a learning curve to managing both the technology for the assessment and the videoconferencing technology simultaneously. Most have felt that with practice, over time, they have become more comfortable. Most importantly, raters have reported that they do not believe there is any compromise to the validity of the testing or the data.
For more information about using remote assessments in your next clinical trial