Patient Cooperation Committee The 2nd Patient Organization Advisory Board
The 2nd Patient Organizations Advisory Board (March 29, 2018): Introduction from JPMA and exchange of opinions on drug development (clinical trials)
1. "Distribution of Advertising Materials for Pharmaceutical Professionals to General Participants at Conference Exhibition Booths, etc. (Q&A)" and "Consensus Framework
Tokuo Tanaka, Executive Director of the JPMA, cited the “Q&A Regarding the Distribution of Advertising Materials Intended for Medical and Pharmaceutical Professionals at Academic Conference Exhibition Booths, etc., to General Attendees,” issued on March 26 by the Surveillance, Guidance, and Narcotics Control Division of the Ministry of Health, Labor and Welfare’s Bureau of Pharmaceuticals and Food Safety, as one of the first official notifications to provide a legal framework for advertising regulations.The view is that exhibition booths at academic conferences are intended for medical and pharmaceutical professionals and, in principle, are not considered advertising activities directed at the general public. It was determined that providing materials to members of the general public who visit the booths does not constitute advertising activity, provided that the materials are clearly identified as intended for medical and pharmaceutical professionals.It was noted that this notification is the result of continuous advocacy by patient groups over the past two years, as well as JPMA’s ongoing efforts to convey patients’ voices to the Surveillance, Guidance, and Narcotics Control Division. Furthermore, it was explained that this notification was issued with the approval of the Japan Medical Association and the Japan Medical Society.
The "Consensus Framework" was then introduced.
The "Consensus Framework" is a new common approach based on the common interest of the International Federation of Patients' Associations, International Nurses Association, International Federation of Pharmaceutical Manufacturers and Associations, International Federation of Pharmacists and Pharmaceutical Sciences, and World Medical Association to "provide high quality medical care to patients worldwide," and is composed of four pillars. It consists of four pillars.
| Putting Patients First | We put patients first. |
|---|---|
| Support ethical research and innovation | All partners promote clinical research and related studies to generate new knowledge about effective and appropriate treatments. |
| Ensuring neutrality and ethical behavior | We will always maintain ethical, appropriate and professional interactions. |
| "Ensure transparency and promote accountability." | All partners will promote transparency and accountability in themselves and in their collaborative activities. |
This framework is not mandatory. We plan to introduce this framework and our initiatives at APEC in Tokyo in July 2018, where we plan to hold a Tokyo Declaration and signing ceremony.
Comments from Advisors
Patient groups have often expressed a desire to know information from pharmaceutical companies, and while we have been hoping for relaxation as needed, this notice is a notification, and patient groups will continue to lend their support, so we ask for your continued help.
2. "Tohoku Medical Megabank Project
Hiroaki Yoshida, Director of the Research Promotion Department of the JPMA's R & D Committee, introduced the Tohoku Medical Megabank.
Tohoku Medical Megabank is a project that began planning in June 2011 to provide long-term health support for residents in the affected areas after the March 11, 2011 Tohoku earthquake and tsunami, and its activities were budgeted and started in April 2012.
This project aims to collect information such as height, weight, blood pressure, medical history, and blood data from healthy people (community cohort: over 80,000 people; three-generation cohort: over 70,000 people) and follow them for several decades. Healthy people are those who can walk to the hospital, which includes healthy people and some patients. The unique feature of this project is that it is a "composite biobank" that stores not only raw samples but also analytical data. We believe that the ability to follow the process of disease onset and severity of individual patients as the years go by will lead to the elucidation of early treatment and prevention methods. We also believe that tracking the progression of symptoms will be useful in promoting clinical trials targeting Japanese people based on their individual backgrounds. The JPMA Industrial Vision 2025 has four visions. One of them is "Leading the next generation of medicine through advanced drug discovery: Contributing to P4+1 medicine.
P4+1 medicine stands for Personalized, Predictive, Preventive, Participatory + Progressive It stands for "Personalized," "Predictive," "Preventive," "Participatory," and "Progressive," meaning next-generation medicine that evolves drug discovery in line with the sophistication of existing technologies and provides the best medicine for each patient at the right time, based on the patient's understanding of the disease.
To realize this vision, we believe it is necessary to "promote prospective cohort studies" and have established a task force. Prospective cohort research refers to the collection and analysis of health and medical data with continuity through follow-up surveys of healthy individuals.
JPMA believes that the promotion of prospective cohort research contributes to the health of the public and at the same time benefits the industry, and by collaborating with Tohoku Medical Megabank, we hope to create a sustainable mechanism to promote next-generation medicine.
The Tohoku Medical Megabank has obtained prior consent to use the data for industrial research, so the JPMA can use the data. We believe that the accumulation of data on healthy people, which cannot be obtained at ordinary hospitals, and the tracking and analysis of future events that occur in the process of the passage of time from a healthy state, the onset of disease, and serious illness, will contribute to the realization of next-generation medicine, including advanced drug discovery and preemptive medicine.
For access to information, a remote security area has been set up in the JPMA and is connected to the computers at Tohoku University. To prevent data leakage, this area is unlocked using a facial and iris recognition system, and the computers are fingerprinted to limit who can access them. The room is also equipped with surveillance cameras and is audited by Tohoku University.
As for future issues, we believe that public understanding is necessary because approximately 300 people work at Tohoku Medical Megabank, which is a budget and time-consuming project. We also believe that centralization and coordination of information with other cohort studies and advancement of information technology to accumulate medical data from birth to advanced age will be necessary in the future.
Comments from Advisors
- What do you want patient groups to know and what role do you expect them to play?
-We believe that the promotion of prospective cohort studies will contribute to the health of the public and at the same time benefit industry, and we would like to collaborate with Tohoku Medical Megabank for drug discovery. We hope that the patient community will be aware of these efforts. - What is the difference between the other cohorts (Nagahama City and Hisayama Town) and the Tohoku Medical Megabank cohort, and why did the JPMA choose this cohort?
-The difference is that the cohort has sufficient informed consent from healthy participants, and the data can be used by industry with an eye toward drug discovery.
3. "Interview Survey on Clinical Trials" progress report to advisors and exchange of opinions
Prior to the exchange of views
Mr. Mitsuhiro Kondo, Chairperson of the Clinical Evaluation Subcommittee of the Drug Evaluation Committee of the JPMA, introduced a notice issued on March 26 by the Ministry of Health, Labor and Welfare’s Pharmaceutical Review and Management Division. The notice primarily calls for the public disclosure of clinical trial information in Japanese and pertains to the “Registration of Clinical Trial Status.”
This notice addresses the disclosure of clinical trial status and results to third parties to ensure transparency in clinical trials, as well as the protection of trial participants and ensuring access to clinical trial information for Investigator Sites and the general public.In the past, many companies registered on overseas websites, such as ClinicalTrials.gov, and disclosed information only in English; however, they will now be required to register in Japanese as well.Currently, the number of websites that allow registration in Japanese is limited; therefore, until the necessary infrastructure is in place, the JPMA recommends registering on existing websites such as the Japan Pharmaceutical Information Center (JAPIC) to facilitate the disclosure of information in Japanese.
While the information on clinical trials available to patients is still insufficient, we will continue to work toward improving the situation.
Progress report on "Interview Survey on Clinical Trials" and exchange of opinions
Drug development that utilizes the voices of patients is also called Patient Centricity, and as one example, patient participation is being considered, such as involving patients in the preparation of clinical trial protocols and consent explanation documents. The JPMA has also established a task force since fiscal year 2016 to promote this activity. They were divided into three categories, and opinions were exchanged.
Awareness" introduced
1) Drug development utilizing patients' voices (Patient Centricity)
- The challenge is the need to clarify "what they want" and "what kind of hints they want to get" when communicating with patients, and then to communicate with them at eye level.
- Discussions with patients who have a certain level of knowledge are effective for making drug development more useful, but some said they feel hurdles in participating in the discussions themselves, and the importance of acquiring knowledge about clinical trials, etc. and building a system.
- In Europe and the U.S., a system has been established to incorporate evaluations by patients and patient groups in the drug review process, and educational programs for patients have been established.
- Given the current situation where there is a gap between pharmaceutical companies and patients beyond imagination, how much can we change our mindset and get closer to patients in the future?
2) Disclosure of clinical trial information
- While it is necessary to create a system that allows patients who wish to participate in clinical trials to do so, problems related to participation in clinical trials sometimes occur due to a lack of understanding about clinical trials. The need to eliminate problems as much as possible and the need to reconsider the method and content of information disclosure, rather than just one-way information provision from pharmaceutical companies, by placing the highest priority on who the information should be disclosed for.
- Although the authorities have issued a notice regarding the release of clinical trial information in Japanese, they have not yet taken steps to improve searchability or to disclose the names of Investigator Sites.
(3) Clinical trial awareness
- When delivering clinical trial information to patients, it is important to establish a method for sharing the information and give consideration to patients who are interested in the information.
- Since the level of understanding of clinical trials among the general public, including patients, varies, there is a need for pharmaceutical companies to approach patients so that they can understand the information, and a need to verify the method and content to see if the information is really reaching the patients who need it.
For future collaboration between patient groups and companies
It was introduced that the following initiatives are being considered for the future.
- It is important to propose a system in which it is common practice to actively promote the disclosure of clinical trial information and to incorporate patients' voices into clinical trials (for example, patients are involved in the preparation of clinical trial protocols and consent documents), and to this end, to promote the approach to pharmaceutical companies.
- We also ask that collaboration with the Patient Organization Advisory Board members continue in FY2019, and promote various initiatives, including new proposals based on the content obtained from the interviews and the review of guidelines regarding collaboration.
Comments from Advisors
The Advisors exchanged opinions with the participants on the "awareness" and future activities introduced in the presentation. The main comments are listed below.
- We understand that the target audience for this report is pharmaceutical companies, but if the report is to be seen by the general public, we would like you to continue to consider writing it in easy-to-understand language and in Japanese.
- In addition to "patients who have acquired a certain level of necessary knowledge," in Europe and the U.S., there is the term "Patient Expert" who has experienced treatment with a certain drug. It would be good if patients who have not only acquired knowledge but also experienced the treatment could participate in the study.
- There are various websites for clinical trial information, such as the Japan Registry of Clinical Trials (jRCT) and JAPIC, but I would like to see the centralization of clinical trial information.
- If you are going to promote awareness-raising activities based on this report, it would be good to set specific numerical indicators.
- Some of the clinical trial websites provided by private companies may contain advertising content, so the industry should be careful not to create misunderstandings.
- It was good that a questionnaire was conducted in advance of this meeting to organize the issues. We would like to learn from the report to be released this time, and we hope that the report will be useful from the viewpoint of patients.
- I hope you will continue to promote this kind of collaboration in 2018 and beyond.
- The Japan Agency for Medical Research and Development (AMED) is also working on a committee for patient participation, and is scheduled to hold training sessions on a trial basis starting in FY2019, so we hope that the JPMA will follow suit and consider specific methods.
- We have heard that medical institutions do not know how to proceed with patient participation, and although it may be difficult, we would like them to consider a manual on how to proceed.
Exchanging opinions
Closing remarks
Finally, Executive Director Tanaka delivered the closing remarks.
“This year, the JPMA celebrates its 50th anniversary. In 1961, when universal health insurance was introduced and demand for pharmaceuticals surged, our strong commitment to the industry led to competition that, in turn, resulted in the widespread adoption of legal and self-regulatory measures.It is no exaggeration to say that the history of the JPMA is the history of distribution improvements; it was an organization dedicated specifically to distribution issues. However, around the same time that the world suddenly shifted its focus to conflicts of interest (COI) following the Gelsinger incident in the United States in 1999, the Patient Cooperation Committee began its activities.We have been active for nearly 20 years, but I have once again come to keenly realize that before we can change society, pharmaceutical companies themselves must change. And if we are to change ourselves, I strongly feel that the role of this committee and the JPMA will become even more significant.“I would like to ask for the continued guidance of all members of the Advisory Board in fiscal year 2019 as well,” he concluded, and the “2nd Patient Organization Advisory Board” meeting was adjourned.
Junko Yano, Patient Cooperation Committee