Clinical trial participants provide an invaluable contribution to research and the generation of new knowledge. Therefore, ensuring that participants are provided with the tools to navigate the complexities of a trial, the results of the trial, and a thank you for their participation is essential conducting a clinical trial.
In order to help clinical research teams make sure participants feel informed and valued, Clinical Trials Ontario worked with the community to create the Participant Experience Toolkit. The Toolkit provides guidance, considerations and examples to inspire the clinical trials community to improve the participant experience. It explores five topic areas which have a large impact on a person’s overall experience in a clinical trial: Participant Information and Support, Participant Expense Reimbursement, Participant Experience Surveys, Plain Language Result Summaries and Thanking Participants.
Collaboration with patients, participants, health charities, patient organizations, Research Ethics Board representatives, clinical research coordinators and industry representatives made this Toolkit possible. To understand the importance of collaboration in the design of the Toolkit, CTO spoke with Maureen Smith, Clinical Trial Participant, Karen Gopaul, Research Ethics Officer, and Alyssa Te, Oncology Clinical Trials Research Nurse.
Creating the Toolkit
The Participant Experience Toolkit was co-designed with people who work in clinical research, clinical trial participants and caregivers. This is part of what drew Maureen Smith to get involved with the design of the Toolkit. “I was thrilled when I learned about Clinical Trials Ontario’s Participant Experience Toolkit. Especially the fact that it was co-designed with patients and the people who will make decisions about using and implementing the Toolkit,” said Smith. “The people involved in the design were able to listen to each other about what patients and caregivers would like to see as well as what is realistic. Because what is the use of creating something that is impractical or doesn’t respond to patients’ needs?” continued Smith.
For Smith, working on the Toolkit was an emotional experience. “After participating in several clinical trials over a period of 54 years, this is the first time that anyone has asked me about my experiences and gave me a voice to say how I think the experience of participants could be improved,” said Smith. “I was grateful to be able to contribute as co-creation can be an empowering experience with benefits for everyone involved.”
Karen Gopaul, previously a coordinator in geriatric clinical trials and currently a research ethics officer, also felt it was important to contribute to the Toolkit. “I wanted to contribute to creating this Toolkit because, from a coordinator’s perspective, it is always beneficial to have guidance on how to maintain participants and how to make sure participants know their contribution to the trial is beneficial and relevant,” said Gopaul. “From an ethics officer perspective, I see a lot of submissions that have the potential to help so many individuals and I hope this Toolkit will provide guidance to sites to ensure the success of the trial.”
Alyssa Te, an Oncology Clinical Trials Research Nurse, wanted to contribute to the development of the Toolkit in order to help those who are getting started in clinical trials. When she began working in clinical trials, she felt she had a lot to learn despite already having about 4 years of experience in research. “There were a lot of things that I would have liked to have been aware of, not only for my own practice as a clinical trials nurse, but in order to know how my practice would affect the patient experience,” said Te.
Using the Toolkit
The Toolkit includes valuable resources for those looking to improve the participant experience in their clinical trial. Downloadable, customizable templates for plain language results summaries and thank you notes are two of the key resources included. Plain language result summaries should be given to clinical trial participants at the end of a study to help participants learn how they contributed to new knowledge. And formal thank you notes are a way to recognize a participant’s contribution to research.
According to Maureen Smith, she has only received the results of the study and a formal thank you note from one clinical trial. “I was struck by this because it was the first time and I remember how meaningful it was. It hasn’t occurred since then,” said Smith. “I would like clinical trial teams to understand that even though people participate in clinical trials for different reasons, it is important to recognize our contribution and treat us like valued members of your study,” continued Smith.
Karen Gopaul hopes that the Toolkit will be used in numerous ways. “I think that the toolkit is definitely beneficial at all levels of a clinical trial,” said Gopaul. “From an ethics review perspective, the information in the toolkit can be used to provide feedback to sites. Plain language summary templates can be used as a resource to ensure content and format are non-technical, and we can look at the ways researchers plan on thanking participants.”
For Alyssa Te, the aspect of the Toolkit which she finds most useful is the Participant Information and Support topic area. “Many patients, especially patients with a new diagnosis, often view clinical trials as a desperate place to be or a last-ditch effort,” explained Te. “But one of the things that we want them to be aware of is the fact that clinical trials are one of several options for patients.”
Through the resources in the Participant Experience Toolkit, clinical trial teams can help participants navigate the complexities of clinical trials, keep participants informed and make sure their value is recognized.
If you have any questions regarding the use of the Toolkit, please contact info@ctontario.ca.