Virtual Reality for the Pandemic: The clinical research space has had an overwhelming negative response in the past few months with the untimely hit by Covid-19 pandemic across the globe. With a wind down in clinical trial operations, the pharmaceutical industry has been struggling to conduct the usual onsite clinical trial visits. Thus, most pharmaceutical sponsors have suspended all new clinical trials from initiating and curtailed on the new enrolments in ongoing trials. On a recent survey conducted by 3H Medi Solution Inc., on Seikatsu Kojo website (https://www.seikatsu-kojo.jp/) during the period from 15th April 2020 to 19th April 2020, the following trends were collected from 1,255 survey respondents who are currently enrolled in a clinical trial or have participated in a clinical trial previously. The public response on clinical trial participation during this period of Covid-19 pandemic, is positive. Over 40% had a very strong intention in clinical trial participation, while a further 31% were keen to be part of clinical trials during this period. The pie-chart below gives the breakup of numbers on the interest shown by survey participants on clinical trial participation during Covid-19 pandemic period.

This is the hour to accommodate innovative ways to conduct clinical trial operations to stop the industry coming into a standstill and give confidence to subjects who still want to continue in the clinical trial journey. The switch to virtual or home based clinical trials has been a timely response. To meet the growing demand, the US Food and Drug Administration has recently updated their guidelines on the conduct of clinical trials in the face of the pandemic. The FDA has given charge to the sponsors to conduct virtual patient visits in lieu of the on-site visits. The FDA has issued a notice stating that changes to the protocol can be implemented immediately following a review by the institutional review board and a notification to the FDA. An insight has been provided on the administration of investigational product to trial subjects by the FDA. The sponsors can take a call on investigational drug administration if it has benefits to its participants in comparison to alternatives.

3H Medi is pioneer for virtual/Home based clinical trials support in Japan.

Preparedness of 3H Medi Solutions for Virtual / Home Based Trials: Technology has brought rapid innovations to the healthcare sector in the recent past. Clinical trials have rigorous practices to meet efficacy and effectiveness, however today through the use of smart technology, the clinical trial conduct is slowly catching up to adopt virtual clinical trials through e-health visits for same effectiveness and accuracy. Virtual patient centered trials occur at a patient’s setting opposed to a trial site giving a more sense of comfort to patients.

3H Medi Solution has already adopted virtual and home based clinical trials through the use of latest technology, facilitating a streamlined process for both pharmaceutical companies and patients.

The 3H Medi Solution has collaborated with health technology industry consultants to improve the technology outlook of clinical trials conducted across Asia.A fine example is the virtual adverse event monitoring of an ongoing oncology study done by 3H Medi Solution, where the quality of life of patients along with vital signs are measured through digitalised home-grown 3H P- Guardian system where alerts endangering patient safety are sent on real time to medical staff. Smart devices and wearables are thus used to remotely send patient information and medical data to the 3H Cloud PHR server, where it is stored as electronic data ready to be reviewed. The P-Guardian system further empowers patients with medical advice and information to lead a quality life. The use of smart device technology has improved patient drug compliance through digital reminders, improving the accuracy of the clinical trial conduct even in virtual settings. The trial organiser of 3H Medi Solution are able to keep a track of patient drug compliance on how much medication has been taken by a participant, the time of day, place and the dose frequency. The wrist devices used for real time generation of clinical grade ECG’s, and mobile applications for checking clinical grade respiratory symptoms and vital sign measurements have made virtual trials a reality. 　　

The home-care model in clinical trial conduct is where a trained, competent clinician schedules a visit at a patient’s home. The clinician does the drug dispensing and blood sample collection facilitating the procedures of an onsite visit. In case the clinician finds a trial subject in distress, the subject would be directed to emergency medical services immediately. The clinician is trained to complete all necessary documentation and record any changes to concomitant therapy or adverse events. This makes home based trial visits an easy option for subjects.

Home Care Patient Model Adopted in Clinical Research: The in-home clinical trial model has been adopted by 3H Medi Solutions at an additional cost, to better facilitate patient needs and comfort. The new home-visit model is part of the clinical trial contract signed with the medical institutions to align with the medical practice in Japan where a designated nurse, implements the additional support needed to conduct home-based visits. This is already a part of 3H Medi solution service which gives the study patients the comfort of receiving treatment from their homes, which has also drawn a lot of positive feedback.

As the aging population in Japan is on an incline, it is important that clinical trials are set to suit the needs. It is easier for the subject caregivers to have evaluations and therapy performed from a home setting, than visiting a trial centre giving more flexibility to subjects. 

Having a Hybrid trial helps to run operations through a central site for patient enrolment and management, rather than having a network of qualified sites. This way burden on individual sites is minimised and sponsors would not need to allocate large amount of resources. It also shifts trial conduct to attain better quality involving a patient centric trial which is cost effective, more patient friendly and flexible in the future. We are sure to see more of home based and virtual clinical trial settings in future to suit the demand following this pandemic.

To explore the opportunity please contact at imran@3h-ms.co.jp