3H Medi Solution is continuously trying to adopt novel ways to make Clinical trial conduct more efficient and innovative. This has brought about a new facelift to the industry in Japan, with bio-pharma companies being open to having the general population participate in the trial process in formulating protocols and generating data. 3H as a pioneering clinical research company in Japan is laying the foundation to bring in patient engagement and patient centricity to lay a strong foundation for a richer future in the industry. The patient-biopharma collaborative effort is seen to improve the overall success of clinical trials with the birth of the concept of ‘patient centricity’. Involvement of patients in drug development not only helps to improve the quality of life of trial subjects, but also prevent business failures fostering a faster drug approval process.

Patient Participation from the Protocol Development: Escalating costs in trial conduct, the demand for personalised medication and empowerment of patients with medical information has made clinical trials to undergo a metamorphosis in the Japanese industry. To make clinical trials more appealing for patients and for better outcomes, clinicians and patients are collaborating to determine if the molecule under study is safe and effective.

3H is actively using social media and technology to engage patients in the drug development process. This is because patient insight is of utmost importance to 3H as it values the real voice of it’s trial participants. Constant tracking and analysis of patient feedback and actions is in place. Contests are being run and competitions held to collect ideas on how the public feels about study trial designs and protocol arrangements. Open discussions in public forums are actively discussing on structured visit layouts of clinical trials, end points and consent form usage. The responses are reviewed and analysed by pharma companies to help build, patient friendly protocols.

3H also looking into the existing processes in consent form formation with recommendations for its improvement. In this, expert interviews, multi-stakeholder meetings were performed to find the barriers and develop solutions to make the informed consenting process more effective.  The recommendations by expert is towards a more participant-centric informed consent process. The participation of subjects helps to better answer the needs of the subjects and improves clinical trials by promoting a research culture which assists with informed participation of trial subjects.

Further, simple easy to understand language with expectations on known and unforeseen risks are to be included. Also short ICFs which are precise with clear objectives and endpoints, holds more subject attention as observed by 3H.

Patient Friendly Protocols and Importance of Grooming Site Staff: 3H understands that patient feedback is very important in building protocols which suit the real world. Study protocols which invest in understanding the nature and lifestyle of subjects are always better designed protocols. Patient feedback gives real world and closer to life experiences. This way the study protocols are patient centric and cost-effective. Protocols which have patient friendly schedules have proved flexibility to patients and caregivers. This encourages better patient retention and the study staff of 3H are trained to provide better facilities and a conducive environment to conduct patient visits which are not prolonged at sites. Being sensitive to a trial subject’s needs and comfort, the site can attain a higher retention rate which is important for 3H. Training the study staff and clinicians to handle sensitive situations gives more confidence to patients especially during invasive procedures. The objective of 3H and Japanese clinical research culture is to bestow a well-groomed study staff receptive to patient which encourages patient-centricity and a better patient experience.

An open dialogue between Patients, Biopharma Companies and Physicians: The conventional channel for patients to reach the Pharma companies were through the Clinicians. They acted as mediators or messengers passing the messages from patients to Pharma. The route has now been shortened with newer tools and technologies to allow a two-way communication. 3H is using social listening tools to understand what patients are discussing about their participation in clinical trials and their disease state. Patient feedback on online chats, their experience and protocol details help in reducing future trial bias.  

Specially in Japan, building trust and rapport is important through conversation. Patients don’t like to be taken for granted and it reinforces the need to use ways to focus on behaviour which is important for patient confidence. Being reflective, supportive and patient-centred greatly influences the participation rate in a clinical trial. Clinicians should always build a cordial, trusting and engaging relationship with subjects.

Patient engagement to improve patient centricity: Patient engagement will enhance patient satisfaction, which improves their participation and retention. This indirectly enhances industry profits. Educative websites set up by 3H can be accessed through mobile phones today and helps in educating patients on diseases. Digital technology and medical apps help to engage patients too. 3H’s Clinical Trial Application P-Guardian is a great engagement tool used for Clinical Trials here. Traditionally, pen and paper were used to complete patient questionnaires on mental status and overall health. P-Guardian has improved patient-centricity with personalised engagement. Further, wearable sensors used by 3H offers directly transmission of patient data to clinicians as well.