Patient Organization Collaboration Promotion Committee Held the 2nd Patient Organization Advisory Board
The 2nd Patient Organization Advisory Board (March 29, 2018): Introduction from the Pharmaceutical Manufacturers Association and exchange of opinions on drug development (clinical trials)
1. "Distribution of Advertising Materials for Pharmaceutical Professionals to General Participants at Exhibition Booths at Conferences (Q&A)" and "Consensus Framework
Mr. Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), introduced the "Distribution of Advertising Materials for Pharmaceutical Professionals to the General Public at Exhibition Booths at Conferences (Q&A)" issued on March 26 by the Monitoring, Guidance and Drug Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labor and Welfare, as one of the first legally organized notices regarding advertising regulations. The Q&A was introduced as one of the first legally organized notices on advertising regulations. The view is that exhibition booths, etc. at academic conferences are considered to be set up for people related to medical and pharmaceutical sciences and, in principle, are not regarded as advertising activities for the general public. It was decided that providing materials to the general public who came to the exhibition booth would not be considered as an advertising activity if it was clearly indicated that the materials were intended for people in the medical and pharmaceutical sciences. He also explained that this notification was made after obtaining the approval of the Japan Medical Association and the Japan Medical Association.
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 consists 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
Mr. Hiroaki Yoshida, Director of the Research Promotion Department of the Research and Development Committee of the Pharmaceutical Manufacturers Association of Japan, gave an introduction to 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 Pharmaceutical Manufacturers Association of Japan (PMAJ) 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.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) 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.
At Tohoku Medical Megabank, we have obtained prior consent to use the data for research by industry, so we can use the data as a pharmaceutical cooperative. 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, we have set up a remote security area within the Pharmaceutical Cooperative and connected it to 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 was this cohort selected by the Pharmaceutical Manufacturers Association of Japan?
-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 ideas
Mr. Mitsuhiro Kondo, Chairperson of the Clinical Evaluation Subcommittee of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), introduced a notice issued on March 26 by the Drug Evaluation and Management Division of the Ministry of Health, Labour and Welfare (MHLW) regarding "registration of clinical trial implementation status," which mainly calls for disclosure of clinical trial information in Japanese.
This notice mentions that the status and results of clinical trials should be disclosed to third parties to ensure transparency of clinical trials, protection of subjects, and access to clinical trial information by medical institution personnel and the public. Many companies have previously registered on overseas websites, such as the ClinicalTrials.gov website, and only disseminated information in English, but they will now be required to register in Japanese as well. Currently, the number of websites that can be registered in Japanese is limited, so the Pharmaceutical Manufacturers Association of Japan (PMAJ) recommends that companies register on existing websites such as the Japan Pharmaceutical Information Center (JAPIC) until the environment is ready so that they can proceed with information disclosure in Japanese.
Although the information is still insufficient as clinical trial information to be delivered to patients, we would like to continue to make progress in the right direction.
Progress report and exchange of views on the "Interview Survey on Clinical Trials
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 Pharmaceutical Manufacturers Association of Japan (PMAJ) has also launched a task force since fiscal 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.
- The authorities have issued a notice on the disclosure of clinical trial information in Japanese, but have not yet taken steps to improve searchability or disclose the names of medical institutions conducting the trials.
(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.
Toward 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 involvement, and is scheduled to hold training sessions on a trial basis from FY2019.
- We have heard that medical institutions are also unsure of how to proceed with patient participation, so although it may be a difficult task, we hope that a manual on how to proceed will also be considered.
Scene of exchange of opinions
Closing Remarks
Mr. Tanaka, Executive Director, concluded the meeting with closing remarks.
In 1961, when universal health insurance was introduced and the demand for pharmaceuticals increased dramatically, there was a strong desire for our own industry, and as a result of competition, laws and regulations and self-regulation became widespread. The history of the Pharmaceutical Manufacturers Association of Japan (PMAJ) was an organization dedicated to distribution issues, so much so that it is no exaggeration to say that the history of PMAJ is the history of distribution improvement. However, the Gelsinger incident in the U.S. in 1999 was the catalyst for the whole world to take the helm on the issue of conflicts of interest (COI), and it was at the same time that this committee began its activities. After nearly 20 years of activities, we have realized once again that the pharmaceutical companies themselves must change before the world can change. If they are to change themselves, I strongly felt that this committee and the Pharmaceutical Manufacturers Association of Japan (PMAJ) will play an increasingly important role. I would like to ask the members of the Advisory Board for their continued support and guidance in 2019.
Junko Yano, Patient Organization Collaboration Promotion Committee