“MiiLike Study Concierge”; a Solution to Patient Compliance in Clinical Trials?

From the pharmaceutical companies who develop new drugs to the patient who participates in the study, there are various parties that are involved in the conduction of a clinical trial. One of them is the clinical research coordinator (CRC) or more commonly known as the study coordinator. It is usually a medical institution or pharmaceutical company that conducts the clinical trial for the specific drugs, in other words, the middleman between the pharmaceutical company and patients. As clinical trials usually run long-term, there is a need for study coordinators to have constant communication with each patient to ensure that patients are taking the study medications according to the schedule and engage with them to reduce drop-out rates. Therefore, smooth and efficient management is key to a successful clinical trial. Following this, Buzzreach Co. Ltd. is pleased to announce that we have developed the “MiiLike Study Concierge”, a clinical trial management app that prevents participating patients from forgetting and taking too much of study medication and supports the role of the study coordinator. This application will aid in reducing the burden of the study coordinators especially in the coordinator-patient communication side leading to a reduced dropout rate and early approval for new drugs.

  1. 1. Risk of Trial Participant Dropouts
  2. 2. Lack of Study Coordinators and the Circumstances Surrounding It
  3. 3. Features of the Clinical Trial Management Application
  4. 4. Main Functions of the Clinical Trial Management Application
  5. 5. Applicable to All Clinical Research other than Corporate Clinical Trials
  6. 6. Comments from Takateru Inokawa, CEO of Buzzreach Inc.
  7. 7. Contact us

Risk of Trial Participant Dropouts

As stated above, patient cooperation is essential for clinical trials. To obtain valid data for the applications of a new drug that can be approved by the Ministry of Health, Labour and Welfare, it is necessary for participants to take the appropriate dosage of the prescribed investigational drug. However, according to the Pharmaceutical Affairs Daily (March 29, 2017), there is a 1 out of 4 participant dropout rate due to various reasons. Even if billions of dollars are spent in developing a drug and conducting the clinical trial, if the valid data is not collected due to dropouts, the trial itself may be cancelled. In order for smooth execution of the trial, it is necessary to prevent dropouts. This app not only improves compliance with notifications and alerts on medication consumption schedule but also a message function from the clinical trial staff, mainly the study coordinators, and the industry’s first attempt at the pharmaceutical company itself. This will lift psychological burdens off participating patients and at the same time maintaining awareness of participation in the clinical trial and a close relationship with the medical institution and clinical trial staff.

Lack of Study Coordinators and the Circumstances Surrounding It

Japan’s clinical trial data is said to be the best in the world. This is supported by the study coordinators who works at the forefront of the clinical trial market. Recently, however, a shortage of these personnel has become apparent. This field of career is still not widely recognized and the stigmas surrounding it makes it difficult to draw future career paths (Pharmaceutical Affairs Daily, July 28, 2017). One known stigma is gender inequality in the field. As of today, most study coordinators are women and if they are gone, the time taken to deliver new drugs to patients who need new treatments will be delayed. With the ever-increasing development of drugs and clinical trials, the amount of work for study coordinators are increasing rapidly and it is difficult to balance home and work. We aim to reduce the workload by eliminating this situation with the “virtual CRC function” of our app and create a world where drugs can be delivered to patients in need of new drugs as soon as possible.

Features of the Clinical Trial Management Application

The clinical trial management application supports the work of a study coordinator and connects patients participating in clinical trials to medical institutions and pharmaceutical companies. Participants can be notified individually in advanced the medication consumption schedule to prevent forgetting or overdosing (medical compliance) which will be confirmed during visits. In addition to that, since the trial management application has a notification function from the trial staff, it is now possible for adjustments of visit date and update on any physical abnormalities through the application rather than through phone which is the main way of communication currently. Furthermore, administrative communications can also be made in advance such as what to bring to the next visit and inspection details, which greatly reduces the burden of medical institutions and study coordinators. Other than that, as the industry’s first attempt to convey a message of “Thank you” by pharmaceutical companies to the participants of the trial can be done through the app via the “Thank you letter function”. This complies with the regulations of the industry as anonymity of participants is preserved. Approval from pharmaceutical companies can be communicated directly when consenting to participate in a clinical trial, during participation or at the end of the trial. This is the first bridging function that connects pharmaceutical companies and patients as part of the patient-centricity established by pharmaceutical companies. Provision cost is set to start from 200,00 yen per month per clinical trial for pharmaceutical companies.

By using this app, patients can monitor the progress of their disease and clinical trials and reduce psychological stress due to receiving messages from pharmaceutical companies that were far away. Since this app is downloaded and used on the patient’s own device, there is no direct stress associated with reducing the cost to provide patient devices for pharmaceutical companies. In recent years, with the increase of in virtual trials and at-home trials that do require basic visits, we can assume the roles of supporting patients, serving as a substitute for study coordinators and bridge between trial staff and patients. In the future, we plan to update the app to a version that can allow the patient to manage his/her health status such as disease management and medical records so that he/she can continue to use it after the trial.

Main Functions of the Clinical Trial Management Application

Function Details
Visualize and share progress information The patient’s latest information summary screen.
Calendar Confirmation of clinical trial visit schedule input, medication status display/input alert function, and screening schedules at other hospitals and departments outside of the trial can also be entered.
Disease information Web information about disease information created (owned) by pharmaceutical companies or general epidemiological information.
Medication guide Disease-related medication guide information along with disease information.
Library Store and view PDF materials for all patients involved in clinical trials, such as clinical trial participation cards.
Bulletin board A bulletin board in which pharmaceutical companies, study coordinators, PIs, and committee staff write for patients. The main feature is the thank you message function that conveys the feeling of “thank you” from pharmaceutical companies to patients. *No writing from patients
Message Message function that can be sent mainly to patients from study coordinators. * No transmission from patients.
Push Notification Ability to receive push notifications even when the app is closed, on the situation of medication, visits, messages, etc.
Medication photo upload After taking the medicine, you can take a picture of the reduced amount of medicine with a smartphone camera and upload it.
Examination result photo upload A function that, after receiving the screening results, captures the results with a smartphone camera, uploads them for record storage and manages them in time series.
Reward function Motivation function to continue application use, improve compliance, and maintain awareness of participation in clinical trials
Virtual CRC function Functions that support patients and reduce the burden of study coordinators.

Figure 4: Main Functions of the Clinical Trial Management Application

Applicable to All Clinical Research other than Corporate Clinical Trials

The main target for the application is for clinical trials conducted by pharmaceutical companies, but it will also be applied to clinical studies led by doctors and medical institutions. In many clinical studies other than corporate clinical trials, there are many projects that cannot support study coordinators due to budget constraints. This app is designed to include such a cost structure so that it can be applied to projects where such patient support is necessary but sufficient patient support cannot be implemented due to budgetary reasons.

Comments from Takateru Inokawa, CEO of Buzzreach Inc.

The quality of clinical trials conducted by Japanese study coordinators is high even at a global scale. It is not shocking to say that this high quality guarantees the quality of clinical trials in Japan. However, there are some instances where the trial patients are not fully supported due to the shortage of study coordinators in the working environment. Therefore, we want to make this app to aid reduce the study coordinator workload and support clinical trials. Through this app, patients who have chosen clinical trial options that were not familiar to them can participate in clinical trials with peace of mind by connecting not only with study coordinator but also with pharmaceutical companies that are doctors and clients.

For future developments, we will not only listen to the voices of pharmaceutical companies but also study coordinators and patients who actually work in the field. One major concern is the engagement with patients after the trial ends. As we know, patients will most likely still be affected by the illnesses after the trial so we aim to create an environment for continuous communication through the app even after the trial via the “support for treatment” function that can be used throughout your lifetime. Patients will be provided better options for treatment and services that enrich their healthy life expectancy enhancing their understanding of their diseases and countermeasures. Furthermore, by optimizing treatment, we will contribute to reducing medical costs and reducing the burden on doctors, creating an environment where people who really need treatment can receive the treatment they need.

Contact us

Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).

Reference:
1. Pharmaceutical Affairs Daily. March 29, 2017. [Subject recruitment status and issues] Searching for subjects, from in-hospital to out-of-hospital-Patient access is an issue.
Retrieved from https://www.yakuji.co.jp/entry57222.html

2. Pharmaceutical Affairs Daily. July 28, 2017. Respect for the clinical trial coordinator.
Retrieved from https://www.yakuji.co.jp/entry59489.html