Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter
2. Materials and Methods
2.1. Step 1: Drafting the Charter
2.2. Step 2: Socializing the Charter
- How will PGs and patients benefit from this Charter?
- What specific feedback would you like to provide related to wording or information not to be missed?
- What ideas can you provide for successful implementation of this Charter?
- What should the roles and responsibilities of the PG be? and
- What hurdles do you anticipate in the implementation process? What ideas might you have for overcoming these hurdles?
2.3. Step 3: Finalizing the Charter
3.1. Consolidated Feedback from Stakeholders
3.2. The Canadian Cancer Trials Stakeholder Charter
3.2.1. Tenet 1: Making Patient Centricity a Norm in Clinical Trials
- Ensure that studies are designed to realize outcomes that are relevant to patients and includes their preferences and trade-offs, achieve clinically meaningful results and enhance patient quality of life and health outcomes, while minimizing the burden of disease and treatment on patients;
- Increase access to CTs by reducing barriers and ensuring that eligibility criteria are fair and appropriate;
- Simplify the informed consent document to provide transparent, comprehensible CT information in a language that is relevant for patients;
- Engage patients in a two-way communication throughout the CT continuum (CTC), solicit and incorporate their feedback, and provide access to mechanisms, such as digital and mobile health technologies where possible;
- Connect patients to internal and external support programs and other resources through convenient and user-friendly channels; and
- Provide patients with uninterrupted access to CT therapies.
3.2.2. Tenet 2: Supporting Education, Training and Development of Patient Group Members for Effective Participation in the Design and Implementation of Clinical Trial Protocols on Behalf of Patients
- Support training of PGs and evaluation initiatives while working collaboratively with them, encouraging their input and active participation in the development, implementation and reporting of a CT;
- Support PGs’ ability to record patient values and preferences both during and post CT;
- Support training of other research Stakeholders including the Sponsor representatives, to ensure best practices are met in their engagement with PGs; and
- Evaluate and share the impact of our engagement with PGs.
3.2.3. Tenet 3: Collaborating with Patient Groups as Equal and Independent Partners to Optimize the Success of Clinical Trials
- Build strong partnerships with PGs and all Stakeholders by agreeing on joint expectations, responsibilities, and the commitment to promote co-operation;
- Include patient insight in the development of the consent process and patient-facing materials;
- Facilitate the connection between trial participants and PGs;
- Promote awareness and education of CTs among PGs, while integrating their involvement in the design and implementation of CTs;
- Work with PGs to integrate patient needs from the conception of CTs, to expedite and facilitate access to CT information, patient-facing materials and CT consent; and
- Act with integrity and respect the independence of PGs.
3.2.4. Tenet 4: Adhering to Transparency and Accountability throughout the Clinical Trial Continuum
- Bolster trust through open dialogue and interaction with PGs and seeking their input throughout to ensure CT lifecycle and following the CT, as required;
- Work collaboratively with PGs to better understand and address patient unmet needs, preferences and trade-offs, the burden of current treatments and disease;
- Share information with PGs and patients in a neutral, uninfluencing and objective manner, where data is presented clearly and accurately as well as in a balanced and fair context, to allow PGs to form their own independent opinion and interpretation;
- Hold ourselves to highest levels of accountability by ensuring that the independence of all stakeholders involved is maintained and by implementing clear conflict of interest and disclosure guidelines;
- Develop trust and confidence in the methods used;
- Transparently share the aggregate results of CTs with patients and PGs, regardless of the trial outcome, in a timely, efficient and comprehensible manner; and
- Transparently share the individual results with the patient and/or patient guardian in the case of a pediatric study, regardless of the outcome, in a timely, efficient and comprehensible manner.
3.2.5. Tenet 5: Maximizing the Potential to Collect and Utilize RWE/RWD Captured in All Clinical Trials
- Consider RWE/RWD in the collection of data in order to render the results more generalizable to achieve greater external validity, better support access, appropriateness of use and affordability of the therapeutic interventions being tested in CTs;
- Communicate (in lay language for good comprehension by PGs and patients), the research goals, methods, procedures, RWE/RWD collected as well as the findings resulting from the use and analysis of this data;
- Ensure that the RWE/RWD data is complete, reliable, and processed in a consistent manner. Best practices in data collection and analysis should be applied from the initiation of the trial study design and maintained throughout the CTC; and
- Share RWE/RWD data post CT in a timely manner to ensure the greatest impact of patients/caregivers to help with decision making.
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
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Michaud, S.; Needham, J.; Sundquist, S.; Johnson, D.; Hanna, S.; Hosseinzadeh, S.; Bartekian, V.; Steele, P.; Benchimol, S.; Ross, N.; Stein, B.D. Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter. Curr. Oncol. 2021, 28, 1447-1458. https://doi.org/10.3390/curroncol28020137
Michaud S, Needham J, Sundquist S, Johnson D, Hanna S, Hosseinzadeh S, Bartekian V, Steele P, Benchimol S, Ross N, Stein BD. Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter. Current Oncology. 2021; 28(2):1447-1458. https://doi.org/10.3390/curroncol28020137Chicago/Turabian Style
Michaud, Stéphanie, Judy Needham, Stephen Sundquist, Dominique Johnson, Sabrina Hanna, Sharareh Hosseinzadeh, Vatche Bartekian, Patricia Steele, Sarita Benchimol, Nathalie Ross, and Barry D. Stein. 2021. "Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter" Current Oncology 28, no. 2: 1447-1458. https://doi.org/10.3390/curroncol28020137