PATIENT INSIGHTS:
Patient insights the need for feedback – JAMES LIND INSTITUTE
APRIL 2020 REPORT
Delivering feedback on clinical trial results and meeting the needs of participants
1.280 answers from community members in three European countries
Our findings are based on 1.280 responses from community members in the United Kingdom, Sweden, and Denmark, which uncover participants’ needs and preferences regarding feedback on clinical trial results. New data reveals a concerning gap between current practices among professionals and the necessary patient-centric approach. This report provides useful recommendations for improving the practice.
Primary Findings
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98% of all clinical trial volunteers want feedback.
Trial participants seek answers to questions like, “Did the study succeed in finding a new treatment?” and “Was their time worth the effort?” However, 60–90% of participants never receive feedback about their trial. Despite the Declaration of Helsinki stating that patients should have the option to receive study results, most volunteers never get this information. -
Non-reporting by trial sponsors is a problem that must be addressed.
James Lind Institute aims to help solve this issue. Participants want feedback, and trial sponsors genuinely want to provide results but often don’t know how. This report outlines important steps for bridging this gap.
The Five Essential Aspects of Clinical Trial Feedback
- DEMAND: How many patients want feedback?
- RECIPIENTS: Which patients demand feedback on clinical trials?
- COMMUNICATION: What do trial participants expect to be informed about?
- MEDIA: How do participants prefer to receive feedback?
- LANGUAGE: In what language should the feedback be provided?
1. DEMAND:
98% of all clinical trial volunteers want feedback.
They want to know if the study discovered a new treatment and whether their participation was worthwhile.
2. RECIPIENTS:
Which patients demand clinical trial feedback?
All patients who attend the first visit and sign the informed consent form should receive feedback — not just the randomized participants.
3. COMMUNICATION:
What do participants expect to be informed about?
Participants want to know the overall results of the trial, not the minor details.
Patient feedback in clinical trials is critical to improve patient engagement.
Ensuring clear and concise patient feedback in clinical trials can strengthen trust and participation.
4. MEDIA:
How do trial volunteers prefer to receive feedback?
The majority of participants prefer to receive feedback by email.
5. LANGUAGE:
In what language should the feedback be provided?
Participants prefer to receive feedback in their native language.
Demand for Feedback
At James Lind Institute, we consider it a fundamental right for patients to be informed of trial results. Patients deserve feedback.
Our research shows that altruism plays a significant role in patient commitment, as does the personal desire to help develop better treatments for new patients. This commitment is evident in the shared desire for feedback on results among clinical trial participants. However, 68% of participants in clinical trials receive no feedback at all.
Feedback Demand Statistics
Patient insights the need for feedback:
- 98% of trial volunteers want feedback
- 2% do not want feedback
- 32% receive feedback
- 68% participate without receiving feedback
The Declaration of Helsinki
The Declaration of Helsinki states that all volunteer patients should have the option to receive information on study results. However, according to TranspariMED, 36% of all European trials fail to list results in the EudraCT trial registry, and approximately 2,400 US trials breach the rules of trial results reporting.
Communicating Trial Results in a Patient-Centric Way
What information do participants expect?
92% of participants prefer a brief report informing them of trial results, while only 6% want the full scientific report. Sponsors need to adapt to provide easy-to-understand summaries for patients.
Lay Summary vs. Full Scientific Report
- Lay summary: 92%
- Full scientific report: 6%
- No feedback wanted: 2%
Case Study: Boehringer Ingelheim
Boehringer Ingelheim works with regulators to develop trial result summaries for participants. They provide an easy-to-use, informative digital overview of trials, many available in multiple languages.
9 Key Questions to Answer in a Lay Summary:
- Why was the study needed?
- Which medicines were studied?
- Who participated in the study?
- How was the study conducted?
- What was the study about?
- What were the study results?
- Were there any unwanted effects?
- Are there additional studies?
- Where can I find more information?
How Should Patient insights the need for feedback Be Delivered?
Sponsors must register results of completed trials in the EU Clinical Trials Register or at ClinicalTrials.gov within 12 months. However, many patients never visit these registers, and they often don’t know where or when specific trial results are posted.
Our research reveals that most patients prefer to receive feedback via email.
- By email: 85%
- Printed version: 6%
- Both by email and in print: 6%
- Do not want feedback: 2%
Language Preference
Most scientific reports uploaded to the EU Clinical Trials Register and ClinicalTrials.gov are in English. This is difficult for many participants, especially those who do not speak English as their first language. Our data shows that trial participants want feedback in their own language. In non-English-speaking countries, nine out of ten volunteers request feedback in their native language.
Preferred Language for Feedback
- Sweden: 90% prefer their native language, 7.6% prefer English
- Denmark: 94.2% prefer their native language, 4.7% prefer English
- United Kingdom: 97.2% prefer English, 0.6% prefer their native language
Conclusion on Patient insights the need for feedback:
James Lind Institute has conducted a research project to understand patient preferences regarding clinical trial feedback. The findings are clear and compelling:
- 98% of all trial volunteers want feedback.
- Participants expect to receive feedback whether they are randomized enrollees or not.
- They want to be informed about the overall results, not scientific details.
- The majority prefer feedback via email.
- Feedback should be in the participants’ native language.
James Lind Institute aims to help solve this issue, as patients want adequate feedback, and trial sponsors want to provide results. Together, we can bridge the gap.
Links to other publications: https://jameslindcare.com//wp-content/uploads/2025/01/Patient-Insight-Gastroparesis-Nov-2019-James-Lind-Inst_new.pdf
