Each time I oversee a clinical trial, I mentally prepare myself to approach uncomfortable situations with grace and diligence. Ensuring patient safety, encouraging protocol compliance, and driving patient engagement are all top priorities for which I have found frequent interactions between the study team and participant to be the best strategy. Digital studies help with frequent engagement, often because virtual interaction is the most convenient mode of communication for patients.

In this article, I will discuss my approach to five challenging real-world scenarios that I’ve encountered while serving as PI for ObvioHealth, and how I’ve handled each in the digital space.

Scenario #1 – A participant expresses concern over potential conflict with work schedule.

In a traditional setting, this conversation is challenging, as site visits require the participant’s travel and time. It’s important to highlight the practicality of a digital clinical trial, as the patient experience is likely to be quite different from what occurs in a “brick and mortar” trial. Digital trials offer the convenience of fewer site visits (if any), live communication with the study team, and remote completion of study activities (i.e. while patient is at home or work). Even so, I try to vocalize our commitment to improving the user-experience.

Scenario #2 – As a PI, you must deliver potentially life-altering news to a participant.

Delivering bad news is unavoidable, and participants are rarely aware of the information beforehand. A participant may react unpredictably, showing anger, frustration, shock or even disbelief.
While text messages and digital chats are useful, this is an instance when it’s best to pick up the phone and call the patient.

This allows you to convey the urgency of the findings, express empathy in real-time, and affords the individual an opportunity to share intimate information with the study staff. Then, from a medical standpoint, the following process is followed: describe the severity of the findings, detail possible implications, suggest a follow up method, and allow an opportunity for questions to be asked. Finally, I suggest possible factors of the findings (e.g. excessive drinking, poor diet, etc.) before urging the participant to visit his or her doctor. Naturally, considerations must be made as to whether the participant should remain in the study.

Scenario #3 – A participant believes they’re either on placebo or the study product is not working.

Most placebo-based clinical trials are double-blind, neither the study staff nor the participant know who receives the study product or the placebo. If one truly believes they’re on placebo, or the study product to be ineffective, it is wise to remind them of the altruistic aspect of study participation. Patients play a crucial role in the development of treatment options that may ultimately reach the market – potentially offering relief to those suffering from a similar condition.

It’s also important to sustain engagement and encourage study completion/compliance. This is much easier in a virtual study because conversation with the patient can occur daily via digital chats.

Scenario #4 – A participant raises concern of a potential adverse/serious adverse event (AE/SAE).

As a PI, it’s my responsibility to analyze each situation from a medical perspective and remove a participant if their health is compromised by the study product. Once a health-related concern is reported, it becomes my job to determine its causality (if any) to the study product, regardless of the severity of the symptom; even the common headache can be viewed as an AE.

The digital space creates an environment where the study staff can better monitor for an AE/SAE. Patients don’t have to wait to speak with me, or my staff, but instead can relay a chat message via their smartphone at any time during the day/night. For example, a patient with severe COPD once messaged us to report headaches; I immediately knew to determine if they were a secondary symptom of her condition or the study product. I ultimately chose to change when the product was consumed, helping reduce the intensity of the headache. Secondly, in alignment with their doctor, recommended testing for worsening COPD. This case was followed till patient finished the study successfully. This interaction could have taken much longer if not done digitally, potentially further compromising the patient’s health, and ultimately losing patient engagement.

Scenario #5 – A participant threatens to drop out of the study.

It’s not unusual for a patient to feel “detached” from a study. Employing a simple and efficient mode of digital communication can go a long way in changing this mindset.

In my experience, there are primarily three factors that motivate a participant to threaten study abandonment: perceived inadequate compensation, absence of symptom relief, and lack of altruism. I’ve had participants criticize the form of compensation (i.e. gift card) or show frustration with the compensation amount. Other times, patients expect immediate relief from their symptoms, and express indifference in helping to advance treatment options for others. No matter the factor(s) influencing the patient’s desire to drop out – digital interactions at the patient’s finger tips increase the probability of retention. Standard “brick and mortar” trials can be frustrating in this department; think of the time a patient spends waiting to hear back from a busy doctor via phone call, or scheduling and then attending an appointment.

Simply put, poorly executed patient centricity can cause extensive strain on protocol compliance and engagement, a recipe for an ineffective clinical trial shaped by overburdened patients.

 

Written by Parth Shah, M.D., Senior Director of Medicine and Economics

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.