From an operations standpoint, we continue to see many ways in which the industry benefits from using wireless technology run virtual clinical trials. In its simplest form, text messages can be critical reminders of subject visits. Confirmation of attendance can be handled with a simple reply of “C” to confirm an upcoming appointment.
Other benefits include electronic diaries, questionnaires, ECG or other equipment transmission to a central party, and assistance with verification of proper dosing with specialty caps. In general, supplemental use of electronic systems definitely has its place in clinical research. It can ensure compliance, reduce overall study cost, reduce errors and reduce timelines in every stage of a clinical trial (study start-up through FDA submission).
However, there is still a wide scope of challenges associated with the use of wireless technology: the initial cost of equipment investment, devices becoming outdated or obsolete, equipment failure, data security (such as the need for encryption in transmission and password protection for access), the complexity in a global study (i.e. translations), loss of equipment, equipment failure, loss and/or corruption of data, subject compliance with use, subject understanding of use (training) and access to a viable internet connection.
The FDA guidance does address some of the larger concerns, such as data loss or corruption—both of which happened to me personally, albeit very early in the electronic age. At that time, we had paper back-ups in place for all electronic data in the event of loss or corruption in transfer. While I’m not sure if the need for paper back-ups is still necessary in the grand scheme of mitigating risk, I do feel that discussions around the integrity of the electronically transmitted data should still very much be occurring with the vendor during start-up to ensure there are measures in place to protect the data.
And even as we address more of these challenges and risks, I do not feel that clinical trials will ever be 100 percent virtual. While there is much that can be adapted to an electronic environment, there is still value in seeing study subjects face-to-face, and, depending on the targeted population, some subjects may only feel comfortable addressing matters in a closed-door, one-on-one setting with their healthcare provider.
Additionally, even with the advances in camera technology, I personally feel that to gain a level of comfort in accomplishing a full assessment of experimental drug exposure in a subject, the doctor will need that time. In our world of DVRs and diminishing attention spans, pushing all study visits to telephone-based visits will begin, in my opinion, to lend itself to glossing over potential adverse events or necessary dedicated follow-up. It’s important to remember that alternate uses for experimental or marketed drugs have been discovered in the field. We owe it to our ultimate patient population to allow for this full and unrestricted review.
So what do you think? Do you think there will ever be a time when a clinical trial can go 100% virtual? If so, under what circumstances might this be appropriate? I look forward to continuing this discussion!