• “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

  • Clinical Trial Platform “Puzz” Brings Clinical Trials Closer to Patients

    Buzzreach Co., Ltd. (Head office: Meguro-ku, Tokyo; CEO: Takateru Inokawa), who is currently developing clinical trial information infrastructure for patients is pleased to announce that the clinical trial information platform “puzz” has been released on March 5, 2019 allowing access to approximately 2.5 million clinical trial applicant database from partner companies, healthcare media, etc. We will also announce that we have raised approximately 50 million yen in seed round funding led by KLab Venture Partners Co., Ltd. for the purpose of further development of this service.

    1. 1. The clinical trial dissemination platform “Puzz” for pharmaceutical companies/ medical institutions
    2. 2. Information matching platform Smt (Search My Trial) for general consumers
    3. 3. Major Issue in the Industry: Low Availability of Clinical Trial Information
    4. 4. Comments from Takateru Inokawa, Representative Director, Buzzreach Co., Ltd.
    5. 5. Fundings
    6. 6. Future Business Developments
    7. 7. Contact us

    The clinical trial dissemination platform “puzz” for pharmaceutical companies/ medical institutions

    Puzz is a clinical trial information dissemination platform for pharmaceutical companies and medical institutions to publish and disseminate clinical trial information to the general consumers as well as enquiring patients allowing them to apply for clinical studies. On puzz, clinical trials information can be registered not only at the medical institution level but also at a project level, enabling detailed settings and information deployment. By posting clinical trial information on puzz, information can be disseminated to a patient database, healthcare media, patient’s association etc. The registration fee for puzz is free of charge however there is a paid plan option where we can support multiple projects of different duration. In addition, the clinical trial information posted on puzz links with the clinical trial matching platform smt (Search My Trial * beta version) operated by our company hence enabling the matching of trial information to patients seeking new treatments. This will allow us to provide an infrastructure for managing patient information in clinical trials. The process of drug development is costly, and this is usually due to the extension of enrollment period therefore, pharmaceutical companies are constantly aiming to finish development in the shortest possible time. By introducing puzz (beta version), several pharmaceutical companies have shortened enrollment period by two months, reducing costs by about 45 million yen.

    Information matching platform smt (Search My Trial) for general consumers

    Smt is a service that matches patients, families and general consumers seeking information on new treatments and drugs on the web with all clinical trial information in Japan. You can not only specify on clinical trial information that is appropriate for your own or your family’s situation but also the neighbourhood in which the relevant clinical trials are conducted (*The name of the medical institution is usually masked and only area information is available). This will open a new pathway for patients in the sense that they could participate in “clinical trials” as a new option other than the treatments they are getting from a general doctor.

    Major Issue in the Industry: Low Availability of Clinical Trial Information

    Clinical trials play an essential part in ensuring that new drugs are safe and effective. However, with only limited sites providing information on ongoing trials, it proves to be a challenging task for patients who are not satisfied with their current treatments to look up new trials that may be lifechanging for their conditions. The number of clinical trials conducted in Japan is increasing annually and 693 clinical trial plans were notified in 2017 (National Institute of Health and Medical Technology Pharmaceutical and Medical Devices Agency https://www.pmda.go.jp/review-services/trials/0014.html). Among them, 136 are undergoing clinical trial plan submissions showing that many new drugs have reached the clinical trial phase every year. Furthermore, there has been a shift of trends for drug development for treatments towards untreatable diseases such as cancer, dementia, psychiatric diseases, childhood diseases, rare diseases, gynaecological diseases, etc. These drugs may be the only chance for some patients in later stages of diseases and without efficient conveyance of information to these patients, they may just miss their chance to treating the disease and prolonging their life. Therefore, based on the current situation, we have released trial matching platforms smt and puzz in order to eliminate the information gap between patients, pharmaceutical companies and medical institutions. Not only will patients receive the information on new drugs efficiently, but the drug development cost will also be lowered due to the participant referring.

    Comments from Takateru Inokawa, CEO, Buzzreach Co., Ltd.

    At the moment, relaying information on clinical trials to patients accelerates development leading to a reduction in development costs, and more than anything else, new options and hope to patients. Patients are also given full transparency of new drug development status that pharmaceutical companies are working on. We provide puzz and smt (Search My Trial) to connect as many new clinical trial information to people suffering from illnesses. Although there are several companies specializing in recruiting patients for clinical trials and most of them have registered members, those registered members are just awaiting clinical trials for their particular disease since most information on clinical trials is not open to the public. On the other hand, most trials are delayed due to the lack of participants. In order to close this gap, we will open clinical trial information registered on our platform to various companies, media and organizations to improve the availability of this information to the people. Clinical trials are an essential part of the future development of healthcare in Japan. Patients who participate in the trials are representatives of the disease. There are hundreds and thousands of people who suffer from similar conditions who have no clue about clinical trials. We hope that more people will learn about clinical trials, participate in them and contribute to the further development of healthcare as much as possible.

    Fundings

    In December 2018, approximately 50 million yen was raised by third-party allotment, led by KLab Venture Partners Co., Ltd. With this funding, we will focus on other services that focus on patients seeking a better environment than the current IT-based environment, as well as expanding the current puzz and smt services we have released this time.

    Future Business Developments

    In order to provide patients with better treatment options, we will develop a service that delivers optimal information for each patient with the provision of clinical trial information. In the spring of 2019, we plan to connect investigators and participating patients, release a patient management app that solves various problems, and start creating a community where patients and pharmaceutical companies connect with each other based on “clinical trials.”

    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).