Engaging in clinical trials from the comfort of home is music to the ears of patients. Though talks on conducting clinical trials virtually has been present, the disruption by Covid -19 has rapidly made virtual trials a reality.

The pandemic raised concerns on conducting clinical trials safely without suspending or postponing patient visits to ensure the safety of trial subjects. The most practical solution was conducting clinical trials virtually, which gives subjects flexibility and reduces their burden on physical visits. Online video calls and the use of smart wearable devices has become the most popular trend. Innovation through disruption in the Health-Tech industry is the new norm. 3H was quick to grab this opportunity to resolve the worries of physical monitoring into digital monitoring of patients to assess their health and safety data.

Patients with malignancies are a soft target during the pandemic due to their immune-compromised state. Understanding this situation, 3H through its P-Guardian system was able to set up an adverse event monitoring system for an Oncology Study. This was one of the first of its kind in Japan and conducted as a pilot study using 111 cancer subjects from 2020/1/8 to 2020/2/7 where they were divided into 3cohorts. Group A to install the 3P Guardian System on their smart phone, Group B to enter data into a rented smartphone with the 3P Guardian App and Group C to use a personal smartphone and rented smartphone with the 3P Guardian app installed. The 3P Guardian was used by subjects for 35 days following baseline assessment. The results were computed and Group C received an alert by email which was sent by the central patient management department.  

During this period the P-Guardian system was validated and weekly patient reported outcomes were monitored electronically (PRO-CTCAE) to capture symptomatic adverse events in cancer patients. Additionally, a functional assessment of cancer therapy was measured monthly to understand the health-related quality of life of patients undergoing cancer therapy. Through smart wearables, the activity levels of these subjects, heart rate and other vital signs were measured.

Importance of virtual studies:  Virtual studies are a major turning point in healthcare. It has improved patient centricity and patient retention while reducing drug manufacturing costs. Japan which was using virtual trials minimally in the past is set to expand virtual clinical trial conduct through the validation received by this oncology study. The digital tools by 3H has shown usefulness, feasibility and operational ease towards scaling up virtual trials. Hybrid clinical studies were done in the past by Dr. Nagashima of the Tokyo Center Clinic and Physician Dr. Hiroshi Takashi where a mix of onsite and virtual patient visits were performed by the study clinicians to gather data for a type 2 diabetes study. This was to observe the physical condition of diabetes patients through an online medical care system and wearable devices. It was observed that these hybrid studies helped in improved patient retention and satisfaction. 

3H is a pioneer in innovating Health-Tech solutions for clinical trials and 3H is expected to expand its health-tech services further in the field of virtual clinical trials.