A strong commitment to patient-centered care has guided the work of the Polish Atopic Disease Association (PTCA), founded to support families affected by atopic conditions. One of the association’s most impactful contributions has been the introduction of Wet Wrap Therapy in Poland, a technique that has helped thousands of patients manage symptoms more comfortably.
This article shares insights from PTCA’s experience reviewing consent forms to improve clarity and accessibility, highlights the importance of early collaboration between sponsors and patient groups, and explores how trust-building can lead to more inclusive and effective clinical trials.
About PTCA
Poland is home to nearly 800,000 individuals living with atopic dermatitis. PTCA supports patients with atopic diseases and allergies, along with their families, across the country. Activities include education, peer support, and advocacy, all aimed at improving patient care. PTCA became involved in clinical trials through its work in patient education and ethical oversight, particularly focusing on informed consent forms (ICFs) and related documents.
Starting the ICF Review
Patients frequently report confusion and anxiety about trial participation. Documentation and protocols do not always fully address patient needs or cover real costs. A gap exists between medical jargon and patient comprehension, especially in ICFs and recruitment materials. PTCA identified this gap and began collaborating with national ethics committees and trial sponsors to improve clarity and accessibility of clinical trial materials.
ICF Gaps
Clinical trial documents often rely heavily on technical and legal language, along with references to databases and biobanks, which can make them difficult for most readers to understand. They frequently miss clear explanations of important elements like benefits, risks, procedures, and concepts such as randomization or placebo use, leaving people confused. One major concern from the patient representative’s perspective is what happens after the trial ends. Continued access to the investigational treatment is not always guaranteed, although some ethical sponsors do provide extended access beyond the study period.
Benefits of Advocacy Partnerships
Three key areas require attention in clinical trial communication. First, better alignment with patient needs and expectations is essential, as many remain unmet. Second, trust and transparency must be prioritized, especially in recruitment efforts. Public awareness of clinical trials is limited, and sponsored advertisements on social media often fail to educate effectively. Third, patient organizations play a vital role in bridging communication gaps. When trust is established with these organizations, patients are more likely to trust the information they share.
Collaboration Roadblocks
Several challenges stand in the way of effective patient advocacy in clinical trials.
- Limited funding and tight timelines are ongoing issues.
- The absence of formal training makes it even harder for advocates to participate meaningfully.
- In international collaborations, language differences continue to be a major barrier to clear communication.
Defining True Partnership
Effective collaboration involves patient organizations contributing to protocol design as early as possible and participating in recruitment strategies. Sponsor-led programs can support skill development and improve competencies, especially where formal training is lacking. Shared goals should focus on patient safety, comprehension, and trial accessibility. Relationships between sponsors and advocacy groups should be built on partnership rather than transactional cooperation.
About the Author
Hubert Godziatkowski is the founder and board president of the PTCA, where he advocates for patient-centered care and supports families affected by atopic conditions. With a background in economics and an MBA in international trade, Hubert brings strategic insight to his work in healthcare advocacy. He introduced Wet Wrap Therapy to Poland and continues to champion meaningful collaboration between patient organizations and clinical research sponsors.
