Ideal experiences, key information, and preferred communication methods before, during, and after clinical trial participation
| Timing . | Ideal experiences . | Key information . | Communication preferences . |
|---|---|---|---|
| Before participation | Learn about the trial from trusted source (eg, physician) Personal physician supports participation All study information accessible and in plain language Less strict eligibility criteria (especially regarding age) to allow more individuals to participate Time to consider participation Trial is sponsored or conducted by a trusted organization | All relevant information about the study intervention(s) (known benefits, side effects, method of administration) Source of research funding and its history with SCD Study protocol and policies (purpose, phase of the study, procedures involved, inclusion/exclusion criteria, volunteer expectations, duration of the trial, number of visits, compensation, reimbursed expenses) | Ability to speak with personal physician to discuss risks and benefits of the study before enrollment and with past participants about their previous experiences Connect with the study personnel by telephone and in-person to address questions or concerns Text messages, e-mails, telephone calls, and face-to-face conversations |
| During participation | Treated as a partner by study personnel Lodging and travel expenses covered if needed Study personnel keep their regular physician informed of their progress and health Participation has little to no impact on personal/day-to-day life Study clinic environments are welcoming and have amenities such as television and Wi-Fi Those enrolled can stay on their existing medication(s) Compensation provided throughout the study as opposed to just at the end Only minimally invasive procedures are required Access to mental health support, support groups, and other resources | Materials to explain the study to others Progress updates (individual and study) Who to contact with questions How patients will be kept safe must be made clear What data are being collected and what is being done with it What role they play in the process | Access to a 24/7 hotline for questions Meet regularly with the study physician as well as their personal physician Mobile apps and patient platforms could help communicate important information Text message reminders for appointments Visual aids to explain procedures Follow-up telephone calls from the study staff to check in |
| After participation | Free access to the drug (if study is a success) Access to long-term care and follow-up Trial sponsor re-invests in the SCD community by sponsoring events or offering scholarships Receive support during the transition to regular standard clinical care Access to counseling sessions Receive recognition for participation Results of the study are communicated to personal physician | Results of the study and personal results/progress in plain language Understand how their participation made a difference What was learned about any new side effects Drug approval status and next steps Information about future trial opportunities How privacy will be maintained in the future | Study results and personal results are e-mailed or sent via surface mail Facetime, in-person, and telephone call follow-ups Public service announcement or media broadcasts of results In-person meetings or conferences to learn more about results and connect with others |
| Timing . | Ideal experiences . | Key information . | Communication preferences . |
|---|---|---|---|
| Before participation | Learn about the trial from trusted source (eg, physician) Personal physician supports participation All study information accessible and in plain language Less strict eligibility criteria (especially regarding age) to allow more individuals to participate Time to consider participation Trial is sponsored or conducted by a trusted organization | All relevant information about the study intervention(s) (known benefits, side effects, method of administration) Source of research funding and its history with SCD Study protocol and policies (purpose, phase of the study, procedures involved, inclusion/exclusion criteria, volunteer expectations, duration of the trial, number of visits, compensation, reimbursed expenses) | Ability to speak with personal physician to discuss risks and benefits of the study before enrollment and with past participants about their previous experiences Connect with the study personnel by telephone and in-person to address questions or concerns Text messages, e-mails, telephone calls, and face-to-face conversations |
| During participation | Treated as a partner by study personnel Lodging and travel expenses covered if needed Study personnel keep their regular physician informed of their progress and health Participation has little to no impact on personal/day-to-day life Study clinic environments are welcoming and have amenities such as television and Wi-Fi Those enrolled can stay on their existing medication(s) Compensation provided throughout the study as opposed to just at the end Only minimally invasive procedures are required Access to mental health support, support groups, and other resources | Materials to explain the study to others Progress updates (individual and study) Who to contact with questions How patients will be kept safe must be made clear What data are being collected and what is being done with it What role they play in the process | Access to a 24/7 hotline for questions Meet regularly with the study physician as well as their personal physician Mobile apps and patient platforms could help communicate important information Text message reminders for appointments Visual aids to explain procedures Follow-up telephone calls from the study staff to check in |
| After participation | Free access to the drug (if study is a success) Access to long-term care and follow-up Trial sponsor re-invests in the SCD community by sponsoring events or offering scholarships Receive support during the transition to regular standard clinical care Access to counseling sessions Receive recognition for participation Results of the study are communicated to personal physician | Results of the study and personal results/progress in plain language Understand how their participation made a difference What was learned about any new side effects Drug approval status and next steps Information about future trial opportunities How privacy will be maintained in the future | Study results and personal results are e-mailed or sent via surface mail Facetime, in-person, and telephone call follow-ups Public service announcement or media broadcasts of results In-person meetings or conferences to learn more about results and connect with others |