Every year Princess Margaret initiates upwards of 150 new clinical trials – at any one time they have close to 350 trials underway. Kathie Zeman works at the Cancer Clinical Research Unit (CCRU) within the Princess Margaret Oncology Program which provides leadership, oversight and infrastructure for researchers. Kathie contributes to the CCRU’s Patient and Public Engagement initiatives and is part of the Education and Training team.
Below, Kathie talks to Clinical Trials Ontario (CTO) about her work on CTO’s Participant Experience Toolkit, the importance of plain language summaries for trial participants, and advice for using plain language summary templates.
Can you tell us about your work on the Participant Experience Toolkit?
In 2020, CTO organized a workshop to explore best practices involving clinical trial participant experiences, which culminated in the development of the CTO Participant Experience Toolkit. The workshop involved collaboration among individuals with various backgrounds and interests relating to clinical trials, including participants, academic investigators, trial operation staff, the research ethics board, industry, health charities and patient organizations.
During the workshop we shared current practices and generated ideas for future initiatives focused on enhancing participant experiences in clinical trials. This workshop led to the creation of tangible resources and tools, including the CTO Plain Language Summary Template.
Why and how have you incorporated the Plain Language Summary Template into your work?
Within the Princess Margaret oncology program, we routinely survey our clinical trial participants to obtain feedback on their experiences. To date, we have received completed surveys from over 600 of our clinical trial participants. These participants have indicated that the top factor influencing their decision to participate in future studies is obtaining the overall research results.
This feedback prompted us to develop a means to share clinical research results with participants and the public in an accessible and comprehensible format. We chose to us the CTO Plain Language Summary Template, as we felt it was a valuable and appropriate tool for meeting this objective. Our hope is that this new initiative will serve to provide meaningful information to our participants and the public by facilitating knowledge translation and supporting patient-centred care.
Why do you feel plain language results summaries are important?
There has been a call for greater transparency in communicating information relating to clinical research to both participants and the public. Various stakeholders, including medical journals, publishers, associations, and agencies, have responded to this appeal by making research outcomes available to non-scientific audiences.
I feel that sharing clinical research results with the participants who contribute to the research helps promote inclusivity and transparency by making scientific information more accessible. Plain language summaries also help fulfill an unmet need – participants’ expressed interest in obtaining the results of studies to which they contributed.
As I mentioned previously, our clinical trial participants have expressed a desire to learn about their overall study results. This need is affirmed by the literature, which also suggests that despite participants’ interest in their study outcomes, only a minority are provided with this valuable information.
I believe the sharing of plain language summaries serves to increase patient engagement, promote transparency, and acknowledge the value of the participants’ contributions to clinical research and the advancement of medical knowledge.
What has been the response to the Plain Language Summary Template in your organization?
We piloted the feasibility of developing plain language summaries by offering to create the documents for investigators and study teams involved in several academic clinical trials. We received positive feedback from investigators, study team members, and sponsors representatives, who expressed support for our efforts to engage patients and translate research results into accessible formats.
Following the success of the pilot, we decided to operationalize our initiative, and are working to formalize a process for requesting and developing plain language summaries within the Princess Margaret oncology program. This includes the creation of an application form, process summary, guidance documents, and resources for study teams. We are currently working with our Research Ethics Boards to standardize the application submission process for plain language summaries to reduce administrative burden and turn-around times. We also plan to create a public-facing website to share the plain language summaries of clinical research results with the broader community.
Do you have any advice for others who might use the template?
Many clinical researchers and study staff wish to improve participants’ experiences but may lack the expertise or time to address the return of plain language research results. The CTO Plain Language Summary Template is a helpful and time-saving tool which provides clear, simple guidance on the types of information that participants might be interested in when learning about the study results.
Using a previously formatted template is a big help. We started with the information in the scientific publication and customized the CTO Template with study-specific information, institutional headers, and local contact information.
For those that are new to creating plain language summaries, there are many publicly available tools that can be used to help ensure the language is accessible and appropriate for participants. One example is the Patient Education Materials Assessment Tool (PEMAT) from the US Agency for Healthcare Research and Quality.