About Initiative

Janssen modified and developed new tools to include direct patient perspectives and drive patient centered decisions:

Patient Insights Playbook and Integrated Patient Journey Template
Patients from US, UK, Australia, Taiwan and Korea provided feedback on the PE Playbook. This occurred via in depth interviews. Some modifications have been made and further modifications will be made, especially to terminology, and also to ensure that interactions are mutually positive.

Updated Target Product Profile (TPP): includes direct patient insights
To validate insights from patients, various qualitative and quantitative approaches have been utilized, depending on the project. For example, during a patient advisory board meeting, patients consistently expressed and described the impact of fatigue on their daily lives. Fatigue is well documented in the literature, however hearing directly from patients influenced the R&D team to take action and study fatigue. Although the Target Product Profile (TPP) is proprietary, it includes primary and secondary endpoints, patient reported outcomes, patient benefits, safety, tolerability, and dosing/presentation. Insights should be provided directly by patients based on descriptions of disease and treatment burden and unmet needs.

Customer Value: patient insight into formulation/supply chain
Patient Voice Plans in R&D: patient insight into compound and clinical strategies and protocol design
Elements of study designs modified include reordering tasks/tests and reducing the length of visits. A new Director, Patient Insights has joined the team and is currently conducting studies in over 13 countries with more than 1,300 patients across all 11 disease areas. The purpose is to gather patient feedback on protocols in order to make modifications before protocols are finalized.

A recent example of modifying study design was reordering tasks based on patient feedback. The team originally planned to start with more difficult tasks and end with simpler tasks as a "reward". However, based on direct patient insights, a decision was made to start with simpler tasks and build up to more difficult, so that patients could build confidence. This change will apply to multiple studies for the same disease area.

Internal Compliance Guidebook: best practices on how to implement patient engagement
Practical examples: modifying a device design based on patient insights, resulting in more correct dosing of medication, re-ordering tests in a clinical trial, reducing the length of visits in a clinical trial, decision to measure fatigue and sleep patterns based on patient insights, working with patients to develop a new symptom diary, and involving patient groups in development of web site content. These examples are from multiple disease areas within the company.

Driving change via Patient Engagement Dashboard
Objective: To drive behaviour to incorporate direct patient voice early and understanding barriers.

Activation: they are measuring the amount of organizational change.
Enablers: they are seeking to understand roadblocks to organizational change.
Sustainability: they are measuring the impact of these Patient Engagement activities.

Initiative Purpose

Providing guidance to others in their efforts

Time line

Unknown

Research and discovery

Preclinical

Clinical study phase 1

Clinical study phase 2

Clinical study phase 3

Regulatory Review & Approval

Health Technology Assessment (HTA) activities

Post marketing

Quality of patient engagement

1. Shared purpose

What did you do to achieve this criterion?

Janssen has policies on Patient Engagement, inclusive of transparency (Global, Regional and National regulations).

2. Respect and accessibility

How have you addressed respect and accessibility in this project?

Our existing tools and processes have been updated to include Patients as an additional stakeholder with equal respect in our decision making (Target Product Profile, Customer Value/Formulation Decisions and Integrated Patient Journey). Patient-Reported Outcomes team also created a Patient Voice Plans for R&D at a compound level, to strategically assess and determine what were the best ways to engage with patients in our clinical plans. Patient-Reported Outcomes team knows that there is not a one size fits all methodology for Patient Engagement so we recognize that the unique needs of all stakeholders should be taken into account upfront. How did you check that what you did was appropriate to achieve this criterion? [If possible, please provide examples.] In working with patients on the PE Playbook, Patient-Reported Outcomes team worked with facilitators who are based in the local countries and understand the local cultures, and a discussion guide was used.

3. Representativeness of stakeholders

How have you ensured broad, competent, diverse representation of stakeholders?

For representativeness, it is important to specify at the beginning what is the target population. The Patient Voice Plans, at a compound level, will strategically assess and determine which sample groups should be involved in the project. The Internal Compliance Guidebook and the Patient Insights Playbook also provide guidance and recommendations on selecting representative groups. How did you check that what you did was appropriate to achieve this criterion? [If possible, please provide examples.] One example in France, a patient group provided input into a trial protocol, changes were made, and the group was notified about which changes were implemented and some which were not. Later we decided not to further develop the medicine and the same patient group was notified.

4. Roles and responsibilities

What did you do to achieve clarity and communication as well as regular check-points on roles and responsibilities?

We have Best Practices for certain types of Patient Engagement activities which detail accountability and commitment expectations. We are planning to expand these Best Practices to other Patient Engagement activities. In collaboration with Patient Groups, a video was produced to help patients manage a new diagnosis with IBD. This was a truly collaborative effort, with roles and responsibilities outlined at the beginning, which were modified as the project was underway based on real time learnings. In the UK, the operating company has partnered with a patient organization for a three year period to be measured by the patient group against a set of criteria evaluating the level of patient centricity. A baseline has been identified, and plans have been agreed upon. Patients also helped develop the Patient Engagement Mission, Patient Engagement Playbook, and have provided insights into Target Product Profiles as well as other tools. Patients provided feedback and insights through various interactions including advisory boards, interviews with patients and patient groups, focus groups, surveys, market research and other means. Patients also helped one R&D team develop a new survey to measure symptoms for a disease. The process began with members of an online patient community providing feedback on a draft which was then further modified, and further tested. How did you check that what you did was appropriate to achieve this criterion? [If possible please provide examples.] In both cases (IBD project and patient centric culture partnership), contracts were mutually agreed upon and entered into up front – before the start of the projects - and modified as appropriate along the way. One lesson learned is collaborating on a project slowed down timelines, but it was the right thing to do.

5. Capacity and capability for engagement

What did you do to support building the required capacity and capability for engagement?

The Patient Voice Plans, at a compound level, will strategically assess and determine what support is needed for meaningful engagement in the project(s). The Patient Insights Playbook also provides guidance and recommendations for meaningful collaborations. How did you check that what you did was appropriate to achieve this criterion? [If possible please provide examples.] Training and toolkits have been developed for internal personnel, and moderators from outside the company are selected based on experience working with patients. For a patient advisory board recently put in place for a 1.5 – 2 year period, patients went through an application process. The application was written in a manner appropriate for lay persons, and mutual expectations are being set for engagement between throughout the project.

6. Transparency in communication and documentation

What did you do to achieve and implement processes for timely communication and updated documentation throughout the project?

Within Janssen, we have standardized tools and processes to ensure a harmonized approach to patient engagement. We also store and share anonymized project specific insights so that they can be leveraged in the future. The dashboard is attached here. How did you check that what you did was appropriate to achieve this criterion? [If possible, please provide examples.] A new internal system was developed and put in place to store market research and other appropriate documents so that patient insights can be referred to and acted on regularly. Patients and patient groups have provided consent and privacy rules and agreements have been followed. Before a project begins, materials are produced which are clear and written in lay language.

7. Continuity and sustainability

How did you check that your planning to secure continuity and sustainability was appropriate also for the stakeholders you’ve involved in the project?

Janssen’s policies are set according to global/local laws and regulations and are independently monitored and audited for business adherence to the set policies.

Results and outcomes

Outcomes and results include, but are not limited to: 1) Product formulation/design - modification of a drug/device combination product in development based on patient insights, resulting in more correct dosing. 2) Modification of multiple clinical trials based on direct patient insights, including reversing the order of tests/tasks (protocol modification), providing transportation to the site, and reducing length of visits. In one clinical trial, there were no dropouts for 7 months. 3) Developing medicines that better meet needs: decision to modify a target product profile to pursue a biomarker or faster acting medicine, based on feedback from a patient advisory board. 4) Measuring what matters to patients: decision to measure fatigue and sleep patterns, working with patients to develop a new symptom diary. 5) Co-developing disease educational materials. These examples are from multiple disease areas within the company.

Lessons learned

Learning is that patient engagement requires time and commitment. It is important to have the support of senior leaders, to have tools and expectations and to embed patient engagement into the various departments, such as R&D, supply chain, commercial etc. It is also helpful to hold employees accountable by measuring progress over time. The Dashboard has been in place for 1.5 years. Significant progress has been made and there is still more to do. To operationalize patient engagement, it is important to get support from all functions of the company to embed patient engagement as a way of working. We have also found it helpful to start with “service models” whereby a dedicated resource or department in the company initially conducts the engagements – this can accelerate progress. We have also learned that budget constraints and time can be limiting factors for patient engagement, but as long as everyone is asking what does the patient want and need and as long as patients are directly involved in the development of solutions, ultimately needs should be better met and research should be accelerated.