On November 2^nd 2022, Chugai held a round-table discussion attended by Chugai CEO Dr. Okuda, patient groups, medical professionals, and academics. Since 2020, Dr. Okuda has held annual dialogues with patient group representatives to deepen mutual understanding. In this year’s session, opinions were exchanged with various stakeholders regarding the dialogue’s two topics: “Patient Participation in Research and Development” and “Access to Clinical Trial Information”.

Opening

The event began with a report from representatives of Chugai to stakeholders addressing the company’s initiatives targeting issues that were covered in the previous two dialogues.

One specific example introduced was the development of “Pharmony”,* a solution to incorporate the opinions of patients into the earliest stages of drug discovery research. They explained that, during this process, the company received opinions from advisors of patient groups and patient support groups as part of PPI (Patient and Public Involvement), and that for the first time Chugai collaborated with patient groups in an actual research project. The report went on to share what was learned from patients, and that that vital knowledge has been compiled to improve the drug research environment.

 * Pharmony: Collaborative activities starting at the drug research stage, linking Chugai with patient groups, patients, and patient families, to respect and understand each other’s viewpoints while creating innovative medicine. “Harmony created by Patients + Pharma”.

Discussion

In the discussion that followed, there was a thoughtful and lively sharing of issues, initiatives, and ideas from the multi-stakeholders and Dr. Okuda about the dialogue topics, “patient participation in research and development”, and “access to clinical trial information”.

Discussion around the topic “patient participation in research and development” focused on the importance of ensuring that patient opinions are incorporated into specific goals and actions.

The importance of dialogue was raised again with a stress on the need to set clear goals in discussions with patients about what they hope to achieve from their treatment. Each disease has its own various symptoms. Patients and their families need to be able to maintain a dialogue with researchers to clearly identify their own personal difficulties and what treatment options they should implement, and to identify clear goals and methods to realize practical results.

The patients and their families also stated how important it is to deepen their understanding of the work of researchers. Participants were able to reaffirm PPI’s true purpose of “deepening mutual understanding through dialogue between researchers and patients/patient-families”. Comments that expressed this understanding included: “We aren’t realizing PPI if the patient is the only one to talk. If we establish a relationship wherein the researcher only listens to the patient and says practically nothing, there is a greater chance that the patient’s opinion will be ignored” and “The needs of the patient and the expertise of the researcher are both important. If the patient is not aware of this, it may result in a disadvantage to a great number of patients.”

It is also important that society as a whole understands the PPI initiative. The significance of promoting dialogue among multi-stakeholders was further reinforced by comments such as: “It is important for us to visualize issues and share them with society as a whole” and “we have to create awareness that the medical care of tomorrow must be fostered not only by patients, medical professionals, and researchers, but by every part of society.”

During discussions on the topic of “access to clinical trial information”, it was pointed out that many patients don’t even know of the existence of clinical trials, and that this needs to change. Attendees discussed the difficulty patients have to find clinical trial information, and the disadvantage created from not creating an environment where citizens can find such information presented in a fair and timely manner. They agreed on the importance of creating an environment for patients to find and access accurate information. Surprisingly, they also learned that it isn’t easy even for medical professionals to obtain the clinical trial information they need. Participants flagged the need for medical professionals to understand clinical trial content as another issue needing further consideration.

Discussions continued on how information should be provided. Participants mentioned that the current method of medical professionals providing information is not enough, and that if information is distributed through various channels such as social media, patients would be able to obtain what they need in a timely manner, which will lead to peace of mind. There was also discussion on the patients’ need to access critical information that may have a bearing on whether they live or die.

Other opinions raised regarding information provided by companies included concerns surrounding the PMDA* and patients’ lack of direct access to the information they want, and the corporate regulations stemming from an overly cautious interpretation of the law despite the importance of making sure that the appropriate information reaches the patients and general public. The importance of aligning views and working together with multi-stakeholders was reconfirmed in the discussions, addressing the need to reconsider who the rules are made for and aligning them to patient needs, and understanding the importance of collaboration between patients, companies, and academia in order to realize real change.  

*Pharmaceutical and Medical Devices Act: Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Our Next Actions

During the final theme “Our Next Actions,” the speakers as well as Dr. Okuda took turns to suggest how their thoughts and ideas can be transformed into action by writing their proposals on a flipboard.

Shinsuke Amano (Chairman, Group Nexus Japan)

“Create opportunities for promoting PPI (Patient and Public Involvement) in the drug development process. Dialogue is essential!”

It is important for patients and the public to deepen their understanding of the involvement of medical professionals in order to promote PPI. We want to work with other companies to create opportunities for learning a common language we can share with medical professionals. Dialogues are an important factor to accomplish this that must not be forgotten. We want to establish opportunities for mutual discussion, rather than be one-sided and only listen to patients.

Naomi Sakurai (Representative Director, CSR Project)

“From Beyond to Across”

The corporate slogan of the Chugai Pharmaceutical Group is “Innovation Beyond Imagination.” I suggest we interpret “Beyond” as “Across”, extending across the boundaries that exist between companies and stakeholders. That is one of the next steps.

Atsushi Otsu (Director, National Cancer Center Hospital East)

“A new framework and educational system for industry-government-academia promotion of PPI / establishment of a system to share information on the development of genome medicine and clinical trials”

An information sharing system suitable for the modern age is needed to allow patients easy access to clinical trial information. We hope to develop a new education program for doctor and patient associations to facilitate discussions between regulatory authorities and multi-stakeholders centered on patients regarding efficient pharmaceutical application procedures.

Hajime Iwasaki (Specially Appointed Professor and Director of the Interdisciplinary Research and Clinical Application Promotion Center, University of Yamanashi)

“Deepening understanding of PPI through university lectures”

An information sharing system suitable for the modern age is needed to allow patients easy access to clinical trial information. We hope to develop a new education program for doctor and patient associations to facilitate discussions between regulatory authorities and multi-stakeholders centered on patients regarding efficient pharmaceutical application procedures.

Dr. Osamu Okuda (Representative Director, President and CEO, Chugai Pharmaceutical Co., Ltd.)

“Involving others (and other companies) to develop an environment where drug discovery and development reflect the opinions of patients and their families / Establishing the Committee to Consider Clinical Trial Information (provisional name)”

We want to create an environment for promoting PPI working together with patient groups, other companies, and eventually many other stakeholders so that the opinions of patients and their families are reflected in drug discovery and development. Regarding access to information, I believe that we first need to work on improving the framework for clinical trial information. We plan to develop strategies to enhance dialogues with regulatory authorities as their cooperation is essential.