Involving patients has become essential to effectively accelerate development of better and safer medicines and therapies. Multiple stakeholders are involved in drug development and in many cases patient input is not appreciated at the right time.
Although the relevance of patient involvement is recognised, knowledge on how to effectively collaborate with patients in large public-private consortia is limited. As ttopstart supports with stakeholder engagement activities in IMI & IHI projects from start to end, we have taken the initiative to explore the best practices of patient involvement. This blog will highlight our key findings.
How can we ensure the patient’s voice is also heard and appreciated in the cacophony of voices in these multi-stakeholder projects?
In response to the HIV/AIDS movement in the 70’s, patient involvement has become increasingly important. In the past 10 years, this development further accelerated within research and development of life sciences and healthcare projects. Multiple benefits have been stated for the involvement of patients:
- Patients can be involved in their own care.
- Research outcomes are better aligned with patient needs.
- Research is performed more efficiently.
- Expenses of R&D projects are lower.
- Awareness can be created amongst other patients and the public.
Patient involvement ‘push’
In recent years, the Innovative Medicines Initiative (IMI) has increasingly supported patient involvement, not only for clinical purposes, but also for agenda setting, study design, communication, and ethics of projects. In addition, initiatives such as EUPATI started to help patients understand the medicine development process through education. More recently, EATRIS launched the PERC platform, offering researchers guidance, training and practical tools to get started with patient involvement in early stages of biomedical research. IMI2 promised to increase its patient involvement to 80% compared to IMI1. In 2020, 60% of the projects included patients or patient organisations (POs) as consortium partner, members of advisory board, ethics boards, or members of stakeholder groups. This means there are still many projects in which the patient’s voice is not yet heard.
The multistakeholder challenge
ttopstart consultants are currently involved in IMI projects from the proposal phase to the end of the project and beyond. Within these large consortia, academia, pharmaceutical companies and other industrial partners work closely together. In this context, ttopstart consultants jointly develop strategies to overcome several challenges regarding the implementation of patient involvement and stakeholder alignment. For example; when to involve patients, how to involve patients and how to deal with the different views in multi-stakeholder projects.
Since the successor of IMI1 & 2 – the Innovative Health Initiative (IHI) – started in 2021, even more stakeholders from sectors such as biotechnology and medical technology can be part of a project. This cross-sectoral approach of IHI adds to the complexity of implementing patient involvement. Therefore, to complement our existing knowledge and experience, we interviewed a variety of stakeholders from several IMI projects and identified four main themes that are important for the effective implementation of patient involvement.
Communicate clearly, educate and reflect. It is crucial that stakeholders and patients (representatives) involved in IHI projects clearly communicate their expectations and needs to each other. Additionally, patients should be educated on the research processes and background of the project, while at the same time researchers should be informed on how to involve patients. For example, how to avoid jargon and to apply layman language in their communication. Throughout the project, it is of importance that the stakeholders reflect and provide feedback on the collaboration with the patients and vice versa.
Create a patient advisory group and treat patients like any other stakeholder. Support from a specific patient advisory group increases patient input and by being part of a group patients feel more comfortable to contribute to the project. Additionally, it makes the role and responsibility of patients clear to other stakeholders. When patients are involved in the project, all stakeholders must ensure they treat patients the same as other involved partners, by showing transparency and trust. Moreover, it is important to ensure that these patients are representative of the actual patient population. When recruiting patients, POs can help with their wide network and provide support.
Reserve budget for the remuneration and find a good fit with a PO. Like the other stakeholders, patients and POs make time available and put effort into the project. Ensure to discuss remuneration demands of the patients at the start of the project. To effectively make use of the resources of POs, it is essential to find a PO with expectations that match the needs of the project. If a good match is accomplished, POs can effectively assist in the implementation of patient involvement.
Ask for patient input from the start, throughout and at the end of the project and assign a patient coordinator. Involving patients in the project at an early stage is crucial in order to adjust activities related to, for example, the design of a drug or medical device. In addition, a coordinator within the consortium should be assigned to facilitate alignment between patients and the other stakeholders. This coordinator can be supported by patient advocates and PO representatives. It is beneficial if the coordinator has a background in research and experience with guiding patients to meet the demands of all stakeholders.
What’s next for IHI?
The insights listed above provide some background into the lessons learnt from IMI projects. As IHI will build on the successes of IMI, ttopstart aims to implement these findings into IHI projects from the proposal phase to the end of the project and beyond. To keep up with the patient involvement movement, we will closely monitor developments in the field and continue to learn from the experiences of other projects.
Get in touch!
ttopstart facilitates patient involvement in IMI and IHI projects as a partner. With our constant effort to be up to date on the newest patient involvement trends, we maintain a progressive perspective on how to best advise our clients. Interested to know more? Contact us
Kariuki F. A Guide to Patient Engagement in 2023 | Health Recovery Solutions. 2023; Available at:https://www.healthrecoverysolutions.com/resources/eguide/patient-engagement-guide. Accessed April 13, 2023.
 Levitan B, Getz K, Eisenstein EL, Goldberg M, Harker M, Hesterlee S, et al. Assessing the Financial Value of Patient Engagement. Ther Innov Regul Sci 2018 -3;52(2):220-229.
 LeNET, Bereczky T, Salas RJ, Bullinger L. D4.02 SOP for engaging participation of
consulting and informing the POs and patients in research projects of WP2 and HARMONY PLUS. HARMONY PLUS 2021:44.
 WHO. Patient engagement; Technical Series on Safer Primary Care. World Health Organization 2016:1-26.
 IMI. IMI2 key performance indicators (KPIs). 2017. Available at: https://www.imi.europa.eu/sites/default/files/uploads/documents/About-IMI/mission-objectives/IMI2_KPIs_approved_14_DEC_2017.pdf. Accessed April 13, 2023.
 IMI. IMI impact on patient involvement. 2021. Available at: https://www.imi.europa.eu/news-events/newsroom/imi-impact-patient-involvement. Accessed April 13, 2023.
‘‘Treat patients like any other stakeholder and involve them from the start, throughout and at the end of the project.’
– MANOU KOOY – CONSULTANT AT TTOPSTART