Episode 35: PTCA – Speaking the Same Language: How Patient Organizations and Sponsors Can Align in Clinical Trials
Resources:
- [email protected]: Use this email to let us know what you want to hear about.
- https://www.ptca.pl/
- https://inderocro.com/case-study/atopic-dermatitis-ad-rescue-case-study/
- https://inderocro.com/article/putting-patients-first-in-clinical-trials/
- https://inderocro.com/article/improving-patient-recruitment-in-clinical-trials/
In this episode, we welcome Hubert Godziątkowski, a dedicated advocate for patient-centered care and the founder of the Polish Atopic Disease Association (PTCA), which supports families affected by atopic conditions. With a background in economics and an MBA in international trade, Hubert brings strategic depth to his advocacy work. He is also a pioneer of wet wrap therapy in Poland, a technique that has helped thousands of patients manage their symptoms more comfortably.
In this conversation, we explore:
- PTCA’s review of consent forms
- The importance of early collaboration
- Trust-building between sponsors and patient groups
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 perspective is what happens after the trial ends. Continued access to the investigational treatment is not always guaranteed, although some 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.
Building Trust
Transparency in communication and expectations is essential. Early involvement in planning stages, not just during review, is strongly encouraged. Respect for patient organizations, their time, expertise, and limitations must be prioritized. Meaningful collaboration requires mutual recognition and clear, open dialogue from all parties.
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.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
