PI Perspective: Patient Engagement in a Digital Trial

I’ve been involved in clinical research in the traditional “brick and mortar site” setting, and now, in my current role as a principal investigator (PI) for ObvioHealth, in the digital “virtual site” setting. I’m nearing the end of a clinical study involving blood pressure and using the ObvioHealth app, where product consumption compliance rates were as high as 93 percent. Thus, it feels pertinent to discuss patient engagement and the effectiveness of digital technology in creating a patient-centric trial.

Site visits don’t engage, they disengage.

In a clinical trial setting, not only are visits to the clinic a hassle for patients, but they are not the best way to engage with them. If it feels like a hassle, patients are uninterested. I have found many patients prefer digital “remote” interactions simply due to the convenience. On the flip side, HCPs are often overbooked and understaffed, hindering their abilities to spend ample time with each patient. Unfortunately, this limitation leaves trial participants feeling forgotten or unimportant.

In some trials, site visits are a necessity. In my discussions with trial sponsors, I get the sense that many are uncomfortable with eliminating site visits altogether. However, a protocol can include both digital and traditional methods for data capture. This hybrid system allows for site visits – baselining, a few check-ins, and a final visit –while staying in constant contact through digital communication with the patient in-between. This mix of new and old school often helps reduce the number of clinic visits required. I know if I can save the patient trips to the office to measure end-points, progress, etc., I can decrease the likelihood that the patient drops-out of the study. This provides patients the ability – at their fingertips –to be involved in decisions regarding their health and well-being.

User-friendly method for patients to report outcomes.

Let’s look at a patient that is engaged in a hybrid trial. The patient has signed consent, visited the clinic for an initial visit, and is prepared —smartphone in hand – to participate in the trial. After the patient leaves the clinic, this is the most effective point where I can engage with him or her, and ultimately drive adherence.

When I think about the traditional clinical trial site, and how it is a sterile doctor’s office or clinical environment, I tend to believe patients experience more comfort and less anxiety when communicating with the study team from the comfort of their homes.

The user-friendliness of the digital model allows for patients to send messages to the study team at any time for 24/7 oversight. As a result, monitoring for adverse events (AE) or serious adverse events (SAE) is accomplished in a more effective manner. If one of these events take place, if I can communicate with a patient in real-time, I can analyze the circumstances for safety implications, suggest next steps, and perform a risk/benefit analysis to determine if the patient should remain in the trial.

With the smartphone, data input becomes easier. The digital option helps eliminate the painstaking traditional paper-and-pencil approach. Instead of an epro or paper-and-pencil approach, patients can record daily diaries and other end-point questionnaires directly into their phones. A patient wants to go on vacation? No need to lug the epro or paper diary with them. They simply need their phones.

The patient must come first.

When logistical obstacles are removed, and patients are given user-friendly options for interacting with the study team, we empower them to take an active role in the improvement of their health while contributing to clinical research. While these more advanced methods are sometimes outside of the traditional clinical research comfort zone, we’ve seen how traditional methods forget to engage patients. Putting the needs of the patient first can have a profound impact on research by reducing dropout rates, increasing compliance and providing real-word evidence. Ultimately, this leads to better data, and better therapies.

Written by Parth Shah, M.D., Medical Director

Parth is a physician scientist with diverse clinical and research experience. He is an expert in cardio-metabolic and endocrine diseases and is passionate about improving patient care via advancements in research. Dr. Shah serves as an investigator in sponsored and investigator initiated studies. He has great experience in all phases of clinical trials from planning and development to its execution. Dr. Shah is skilled at providing medical input to cross functional teams such as clinical operations, IT, business development, biostatistics, pharmacovigilance, etc.

Dr. Shah has published many manuscripts in credible, peer-reviewed medical journals and presented research at prestigious medical conferences.

He earned a Bachelor of Science from Youngstown State University, Doctor of Medicine from Washington University of Health and Science, and served as a clinical fellow/researcher at Mercy Health/Jewish Hospital.