I get the sense that the design of clinical trials is being reexamined with an eye toward making them more efficient and convenient for subjects (see: Why Do Some Patients Enroll in Clinical Trials and Others Don’t?). I recently discussed the topic of "siteless" trials in a blog note (see: Site-Less Clinical Trials as a Possible Means to Democratize Them). To add to this discussion, I now want to refer to "remote clinical trials" which were discussed in a recent article (see: The Remote Clinical Trial Concept In Clinical Research), Below is an excerpt from it:
The typical patient of the 21st century expects the experience of navigating the healthcare system to be on par with other customer experiences enhanced by modern technologies. However, the pharmaceutical industry has generally remained quite behind the curve when implementing digital health technologies and interacting with patients within the context of clinical trials. Remote trials—also called digital, virtual, or mobile trials—provide an interesting spin on the use of digital health components to enhance the patient experience....At its purest definition, a remote clinical trial eliminates or significantly reduces the contribution of clinical sites, keeping one central coordinating site for the study, generally one to which the principal investigator is affiliated. Patients enroll and conduct most or all trial procedures from the comfort of their own homes....
[The following are key elements in the organization of remote clinical trials:]
* Patient recruitment using digital approaches;
* Electronic informed consent;
* Electronic data capture at the source (eSource);
* A robust monitoring strategy, including remote risk based monitoring, remote drug adherence monitoring, and telemedicine; and
* A strong patient engagement strategy to keep patients engaged via the remote trial conduct....
A dedicated site with the necessary technological capabilities and a motivated principal investigator are essential for success. A smooth transition should then happen from the patient being recruited and referred to your trial, to being screened and starting the educational aspect of the consent process remotely. With a proper process in place, patients schedule a remote consultation—most likely a videoconference—with the principal investigator to finalize the eConsent process. This would ensure the required patient-physician interaction takes place to provide the patient all the information he or she needs prior to enrolling in the trial.
I believe that the "siteless" clinic trial is most relevant for the less complex studies which can be managed by health professionals other than physicians such as pharmacists. In contrast, the remote clinical trial described above is designed to reduce the number of clinical sites to one, generally the home site of the principal investigator (PI), However the approach greatly increases the need for sophisticated IT, often for the subject convenience. This increases patient engagement. For example, the eConsent process is completed via videoconference but this also provides excellent documentation of the process.
One important reason to switch to one coordinating clinical site is that this centralizes support for all of the critical IT function and support. I discussed the role of institutional review boards (IRBs) in a previous note (see: For-Profit IRBs Replacing Volunteer Hospital Boards to Oversee Clinical Trials). Here I mentioned that the NIH is requiring a single IRB oversee multi-center trials to simplify the process. It thus seems that one of the distinct advantages of the remote/digital/virtual clinical trial is that it usually involves only one IRB at the home location of the PI.