ICH Shifts Strategy to Incorporate The Patient’s Persperctive

The ICH Townhall at the 2024 DIA Europe conference featured insightful discussions on the critical role of the International Council for Harmonisation (ICH) in the pharmaceutical industry and the importance of patient engagement in clinical trials. Key speakers included Lenita Lindström, ICH Assembly Chair and Senior Expert at the European Commission; Gabriela Zenhaeusern, Deputy Head of Stakeholder Engagement at Swissmedic; and David Haerry, Co-Chair Advisory Committee at EUPATI Foundation. They shared their perspectives on ICH’s history, its mission to harmonize technical guidelines, and strategies for integrating patient input into these processes.

ICH’s Role in Global Pharmaceutical Harmonization

Lenita Lindström opened the session with an in-depth introduction to the ICH, detailing its history and critical role in the pharmaceutical industry. Established in 1990 by the European Commission, ICH began as a collaborative venture between regulators and the pharmaceutical industry from the EU, Japan, and the US. Today, ICH includes 21 full members and 37 observers. Lindström emphasized ICH’s mission to ensure safe, effective, and high-quality medicines through harmonized technical guidelines. Over 700 experts are developing and revising these guidelines, spanning safety, efficacy, quality, and multidisciplinary topics.

Lindström highlighted the significant impacts of ICH’s guidelines. In safety, guidelines streamline preclinical testing to reduce unnecessary duplication and promote ethical research. In efficacy, the renovation of the Good Clinical Practice (GCP) guideline (E6) updates clinical trial methodologies and incorporates patient perspectives. Quality guidelines ensure consistent pharmaceutical manufacturing standards. Multidisciplinary guidelines, like the Common Technical Document (CTD), standardize regulatory submissions, reducing administrative burdens. Lindström’s presentation underscored ICH’s role in driving global harmonization, enhancing medicine development, regulation, and post-market surveillance, thus fostering innovation and improving access to therapies worldwide.

Enhancing Patient Engagement in ICH Guideline Development

Gabriela Zenhaeusern discussed ICH’s commitment to integrating patient perspectives into its guidelines, emphasizing values, focus, inclusivity, and sustainability. Although ICH lacks a global patient organization as an observer, it is building a network of patient organizations for collaboration. Zenhaeusern highlighted the revision of the E8 guideline, which underwent extensive public consultation, incorporating feedback from patient groups and stakeholders. The revised guideline now includes provisions for consulting patients during medicine development, ensuring clinical trials better address patient needs and priorities, thus improving study relevance and quality.

The E8 guideline revision was driven by feedback from five research organizations and a consortium of over 100 health researchers from 22 countries. It emphasized the need for modern guidelines reflecting contemporary clinical trial methodologies and patient-focused development. One of the key motivations behind the revision was the need to incorporate more robust patient engagement practices into clinical trial design. The researchers and organizations stressed that clinical trials should meet high scientific standards and be designed with the patient experience in mind. This means involving patients early in the trial design process to identify relevant endpoints, improve trial accessibility, and enhance overall study relevance. For instance, they advocated for including patient-reported outcomes and quality-of-life measures, which are critical for evaluating the real-world impact of treatments.

This example highlights the impact of patient and researcher input in updating ICH guidelines. By integrating patient perspectives, ICH aims to create scientifically rigorous guidelines aligned with real-world patient experiences, leading to better health outcomes and greater trust in pharmaceutical development.

Challenges and Suggestions from the Patient Community

David Haerry provided a patient advocate’s perspective, highlighting the benefits and challenges of patient engagement in clinical trials. He emphasized that patients bring unique insights that can significantly improve clinical research. For example, patients advocated for a combination pill for HIV treatment, leading to a widely successful product that improved compliance and quality of life. Similarly, a patient with atopic dermatitis highlighted that being able to sleep through the night was more critical than a cure, which could shift clinical trial endpoints to address patient needs better.

However, Haerry identified several challenges in engaging patients effectively. He stressed the need for early and continuous patient involvement throughout the drug development process, requiring experienced patient experts. He also highlighted the need for proper compensation, noting that many patient representatives work for free. Inclusivity is another challenge, as many current patient representatives do not reflect the broader patient community’s diversity. Haerry shared a successful example from Switzerland where funding was used to provide stipends to a diverse group of patients advising a University Hospital’s HIV department. These stipends were provided for patient advocacy work, not participation in a clinical study, ensuring that individuals from varied backgrounds, such as a cleaning lady and a head nurse, could actively participate in advocacy without financial burden. This approach demonstrated that financial support is crucial for achieving true inclusivity and active participation.

He called for the International Council for Harmonization to learn from models like the European Medicines Agency (EMA) and suggested developing guidelines on informed consent and patient information material. By addressing these challenges, ICH can enhance the relevance and impact of its guidelines, leading to better health outcomes and greater trust in the pharmaceutical development process.

Moving Forward: Enhancing Patient Engagement in ICH

The session concluded with a lively Q&A segment focusing on the future of patient engagement in ICH. Lenita Lindström and Gabriela Zenhaeusern acknowledged the need for better communication and outreach to patient communities. They proposed strategies like leveraging ICH’s five-year strategic plan to identify guidelines that would benefit from early patient input and providing early notices about upcoming guidelines. This proactive approach would allow patients and their advocates to contribute more effectively, ensuring their insights shape the guidelines.

David Haerry emphasized learning from successful models like the EMA, which has made significant strides in involving patients despite challenges in compensating representatives. He called for the International Council for Harmonization to develop guidelines on informed consent and patient information material, sharing examples from his ethics committee experience where many studies had inadequately informed consent documents. Haerry also highlighted the importance of inclusive engagement, noting many current representatives do not reflect the broader patient community’s diversity.

Summary

The session highlighted ICH’s commitment to incorporating patient perspectives into its processes, emphasizing better communication, inclusivity, and compensation for patient representatives. By adopting these strategies, the International Council for Harmonization aims to create more relevant and impactful guidelines, ultimately leading to better health outcomes and increased trust in pharmaceutical development.