Explaining what happens to research data
Patients, trial participants and the public need to understand what happens to the data a clinical trial collects: what clinical data are, how they are used during and after a study, and how they are shared and protected. Materials that explain it in plain language include short animated videos, one-page printable infographics and an educational toolkit on privacy in data reuse, developed with patients and reviewed with stakeholders and users.
Why the public needs data literacy before joining a trial
As reliance on artificial intelligence has grown, so has attention to data privacy and the individual's right to their data: in 2023 81% of US adults reported concern about how companies use their data and 67% reported little or no understanding of what companies do with it. Clinical research cannot avoid collecting personal data, and it is important to address that tension by promoting education and trust through data literacy initiatives; data literacy is the ability to read, understand and use data to inform decisions. Health and research information have greater data protections than other data collected from and about people, yet there is a justifiably heightened sensitivity about data privacy and data sharing in health and medicine.
Scientific advances during the COVID-19 pandemic and the expansion of artificial intelligence in research were accompanied by an increase in misinformation about data collection, privacy and sharing in clinical trials. That increase was compounded by a general mistrust of the clinical research industry, partly because of problematic practices such as data manipulation, withholding of safety information, and inaccurate or non-existent results reporting. These issues contribute to the public, patients, caregivers and even healthcare professionals being inadequately informed about clinical research and the use of its data. The information available is not developed or formatted in ways that can be easily understood. The pandemic escalated misconceptions and misunderstandings about clinical trials and showed the importance of access to clear, understandable and trustworthy information. Confusion and misunderstanding can introduce fear and mistrust and create barriers to participation, whereas education and clear communication about data use and protections can support it. Through transparency, clarity and honesty, trust can be rebuilt.
Patients and participants need timely, clear information to decide whether to join and stay in a trial, and reassurance that their data will be used only as the informed consent document describes, so print and electronic materials are needed whose language and imagery are understandable, familiar, and linguistically and culturally appropriate.
Short videos and printable infographics
A collaboration between PHUSE and the Multi-Regional Clinical Trials (MRCT) Center offers a series of videos and complementary infographics that explain the clinical research process in plain language and focus on what happens to the data collected during a study. Its goal is to make accessible data materials available to patients and the public, especially those being introduced to research for the first time.
Responding to misinformation and misconceptions about clinical trials during the COVID-19 pandemic, PHUSE began a collaborative pilot in 2021 to produce engaging educational content, organised into logical sections, as short animated videos of about three to five minutes each. The pilot has united representatives of the pharmaceutical industry, patient advocacy and academia from several countries. Video was chosen as an engaging and accessible way to deliver content in plain language. The videos build in complexity and are meant to be watched in sequence, though each can also be watched alone:
- Video 0: Introduction
- Video 1: Importance of Clinical Trials
- Video 2: What Will I Receive and When Will I Receive It?
- Video 3: What is Clinical Data?
- Video 4: Journey of a Data Point
- Video 5: What is Data Sharing?
- Video 6: What is Data Privacy?
By June 2024 Videos 0, 1 and 2 had been released.
Since PHUSE was creating videos, the MRCT Center led the production of materials for settings where video may not be possible or appropriate. It joined the project in 2023 to create simple one-page printable infographics about the collection, management and use of research data, complementing the videos. They can be downloaded, saved and printed for in-person access and dissemination where technology may be limited. The MRCT Center's experience developing the Clinical Research Glossary, which gives plain-language definitions of complex clinical research terminology in measured amounts of focused and accessible information, informed the infographics. They explain what data are, why a participant's data are important in clinical research, and how data are protected. Like the videos, they are meant to inform the public of the significance of research while empowering and destigmatising participation in clinical research.
Five infographics cover key questions about research and data:
- Infographic 1, Your Data, Your Information: defines data and gives an elementary overview of the significance of data to research.
- Infographic 2, What happens to data during a research study?: reviews the life cycle of data during a clinical trial, from data collection to data analysis.
- Infographic 3, What happens to data after a research study?: explains the importance of saving data and how that is done.
- Infographic 4, What is a data repository?: defines data repositories and their role in advancing science through aggregate data collection.
- Infographic 5, What happens to your data when you leave a study early?: gives an overview of what can happen to data after withdrawal of consent, discontinuation of interventions or termination of a study.
In the view of one patient author, multi-modal materials are extremely important for the patient community because they cater to different ways of processing information, different literacy levels and different target audiences, and accessible information is crucial to equitable opportunity to improve health literacy and to awareness and understanding of aspects of clinical research such as data science.
Developing the materials with patients and users
The projects are co-created with patient advocates and patient groups. The same patient author holds that creating a resource about clinical research is not only about its content but also about the right tone, plain language and an appropriate format, especially for topics that are complex to understand, and that involving patients in development helps to widen dissemination, as they share the resources through their own communities and networks.
Clear communication, plain language, tone and empathy matter in such materials, which honour the fact that participants' data come from individuals who care about participating, about understanding what happens to their data and about protecting their privacy. Transparency, flexibility and openness to collaboration with different stakeholders, particularly patients and their caregivers, help to make the content suitable, appropriate and relevant for its intended audience.
Engaging key stakeholders and performing user testing early in development is important, to learn what the audience already knows, what questions it may have and how to put the points in effective, patient-centric ways. Essential changes have at times lengthened the timeline, but the investment is worthwhile because content cannot easily be altered once it is in the public domain. The tendency to keep editing also has to be balanced against its time and cost, and periodic updates are planned for future deliverables.
After the two pilot videos were released, user testing ran as a live comment and feedback discussion on the PHUSE Community Forum, to align future video content with audience needs and determine the direction of the later videos. For the infographics, it was important to engage key partners representing a range of knowledge of clinical trials and data literacy when deciding which topics should become infographics, what information to share on them, and how to describe and depict it.
Collecting and resolving feedback
Both formats go through one process of collecting feedback, documenting the responses and resolving the comments. Feedback is requested through open-ended questions to stakeholders, usually in group meetings or by email, with discussion encouraged whatever the platform. How the responses are documented depends on the complexity and type of deliverable: comments on a video go by email with their timepoints to the videographer, comments on a script are made on the file itself and actioned by the project lead, and comments on the infographics, several of which are in production at once, go into one comments log. Each comment is checked for consistency with the deliverable's current style and discussed with the team to see whether others agree, each request is answered in the meeting with the action taken and its rationale, and the updated deliverable is recirculated to the project team to confirm the changes.
The infographic content was brainstormed collaboratively with significant participant review, and formal feedback was collected three times: after the first text, after the first graphic layout, and once all feedback had been reconciled and the infographic was considered complete.
Language and cultural reach
Feedback from different audiences across different contexts and geographies is valuable. A wide range of perspectives allowed the team to consider how to incorporate linguistic and cultural differences; for example, it discussed various ways of depicting travel to a research site that would resonate with the intended audience.
The project's limitations are no language translation, no representation of low- and middle-income countries on the project team, and a focus that is predominantly northern, western and high-income, and these factors are continuously considered as the project evolves. The infographics were first developed in English. Latin American Spanish was chosen for their translation after a multi-variable assessment focused on the target audience and intended reach, and additional languages will be considered.
A toolkit on privacy in data reuse
Because privacy terms can be difficult to understand, especially for patients, TransCelerate released an educational toolkit on clinical data reuse in 2022. It explains how patient privacy protection works to institutional review boards, ethics committees, health authorities and trial participants. At a participant-friendly level, it shows personal data being progressively anonymised as information passes from the study site to the sponsor and beyond: the participant's name is removed completely at the study site, only the country is kept from the address, and a broken chain stands for the removed link between the participant's identity and their clinical data. Sponsors may use and adapt the toolkit as needed.