By Hassan Kadhim

March 2, 2017 | The typical patient of the 21^st 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.

In the context of a graduate academic degree with the University of Montreal, I had the opportunity to expand on the definition of remote trials, and propose a suitable model for the pharmaceutical industry to adopt to drive patient centricity. 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. Therefore, the remote clinical trial is completely centered on a single clinical site and the patients participating in the study.

To better realize this concept, it is important to define a model of remote clinical trial conduct for the pharmaceutical industry, exploring the different opportunities available at each stage of the trial. Additionally, it is important to consider the ethical and regulatory environments governing the development of a remote study, ensuring that the remote nature of the trial does not compromise the quality, acceptability, and relevance of the evidence generated by the study.

Strongly influenced by my technical computer science background, I tend to think of inputs, data transformations, and outputs when modeling any conceptual entity. As such, the input for a clinical trial is always a patient having a specific medical condition, generating clinical data that therefore serves the output of the trial which would be clinical evidence. Expanding on this a little further allows us to classify the different components of clinical trial conduct associated with inputs, transformations, or outputs. As such, patient recruitment, screening, and consent are classified as facilitating the input; data collection, quality, and monitoring facilitate the transformation; and together these data ensure the clinical evidence (output) is relevant, interpretable, and reproducible.

Driven by this thought process, remote trials are composed of the following components:

• 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.

Troubleshooting

Each of these components can be optimized for remote trials. Patient recruitment today remains the key challenge in any clinical trial and is no less troublesome within a remote context. Using dedicated disease-specific social network platforms, electronic health records, and payer databases promises better and targeted patient recruitment and is certainly a requirement for success. Additionally, using patient clinical trial matching will help refer more patients to your remote trial and help drive patient recruitment up for the trial. 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.

Initial screening procedures like blood draws or patient baseline measurements can be performed from the patient’s home via a mobile nurse network or at a local clinic or pharmacy. Drug and devices for data collection are shipped to patients directly as they are randomized into the trial. A comprehensive schedule of telemedicine visits ensures the patient remains engaged in the trial and facilitates regular interactions with the principal investigator and site staff. Additionally, ensuring patients adhere to the drug regimen during the trial is critical to maintaining confidence in trial data; integrating an eAdherence solution within your remote trial can help. Finally, make sure your risk based monitoring platform properly captures and monitors all clinical trial data generated from your remote trial.

System Roadblocks

Although it is clear in my mind that the remote trial concept is the way of the future for conducting clinical research for the pharmaceutical industry, we are not yet fully ready to seamlessly adopt this concept. Several practical considerations about the therapeutic area, indication, and clinical phase need to be taken into account before applying this concept. Regulatory acceptance of the model and ethical considerations with patient safety and privacy also need to be reviewed. Legal considerations around the application of telemedicine across state and country barriers, as well as logistics for dispensing and shipping investigational new drugs directly to patients must also be thought about. Technological considerations related to data, hardware, and connectivity as well as expertise in implementing and integrating remote clinical trial components are also essential for the success of this concept.

Finally, although it may be expected to have the implementation of remote trials reduce the overall costs of clinical research, I found that initial implementations will likely be more costly than the traditional approach in clinical research, mainly because it will require parallel processes in place while ramping up the learning curve. Despite not seeing an immediate return on investment on the implementation of remote trials, clinical research sponsors should capitalize on the educational returns provided by this concept, and gradually innovate in clinical trial conduct toward a more patient-centric approach. The remote trial model will not completely replace the traditional clinical trial conduct model but rather complement it. The air of resistance toward this concept from clinical research teams and clinical research sites must be met with a gradual culture change to propel clinical trial conduct in the next wave of innovation and better serve the patient of the future. The digitization of clinical research through the remote trial concept is an essential step in that trend. The next generation of millennial patients will come to expect it from us, and it is therefore vital for us to move the needle in that direction.

For more information on the remote trial concept, read Kadhim’s full paper at Scribd.

Hassan Kadhim is a pharmaceutical industry executive having spent the past 10 years in the industry. Hassan is currently employed with Boehringer-Ingelheim and has extensive experience in consulting with Drug Discovery Research and Clinical Operations teams. He holds degrees in bioinformatics and pharmaceutical sciences, both from the University of Montreal in Canada. He is passionate about transforming the clinical research / clinical operations arena to improve processes and enhance the patient experience through the use of digital health technologies to drive Patient Centricity. He can be reached at hassan.kadhim@boehringer-ingelheim.com.