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Reducing Withdrawal of Consent

Reducing Withdrawal of Consent. Group 5 Mike Bancks Lisa Baumann Kreuziger Xiaohui Cui. Participant Selection. Balance ability to recruit and generalizability with limiting enrollment to participants likely to complete study Target populations not adequately served by current treatment

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Reducing Withdrawal of Consent

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  1. Reducing Withdrawalof Consent Group 5 Mike Bancks Lisa Baumann Kreuziger Xiaohui Cui

  2. Participant Selection • Balance ability to recruit and generalizability with limiting enrollment to participants likely to complete study • Target populations not adequately served by current treatment • Consider exclusion: • Drug and alcohol abuse • Concomitant severe health conditions • Individuals living far away • Participants with non-adhearance behaviors at baseline

  3. Informed Consent • Understand trial details • Number of visits • Time for each visit • Blood draws and procedures • Potential side effects • Include intent to complete trial regardless of treatment receiving (i.e. Won’t drop out if allocated to control group) • Important for open label studies or if unblinding occurs • Informed withdrawal of consent • Follow-up for data collection if discontinue treatment

  4. Facilities and Staff • Facilities • Adequate parking or pay for transportation • Awareness of the study in the facility • Comfortable environment • On-site child care • Choose sites with track record of good follow-up • Convenient sites or home visits • Personnel • Friendly & Motivated • Single contact person for study • Flexible  allow alternate appointment times • Willing to follow protocols • Adherent staff Adherent patients • Payment to reflect follow-up work or completeness

  5. Study Design: General Principles • Keep it Simple • Limit number of visits • Collect only needed information at each visit • Use direct data capture methods • Involve participants in study design • Allow large time window for each follow-up • Patient incentives • Update contact information regularly Clinical Trial Logo Here

  6. Study Design: General Principles • Reducing Follow-up period • Decreased drop-outs, burden of follow-up • Longer follow-up can be used for safety and secondary outcomes • Outcomes • Use composite primary endpoints including outcomes available for everyone • Avoid primary outcome requiring invasive procedure

  7. Study Design: Run-In period • Establish tolerability of treatment or adherence to protocol • Less generalizability http://www.sciencedirect.com/science/article/pii/S000282239900423X

  8. Study Design: Add-on Design • Add the study treatment to an optimized effective regimen • Reducedropoutdue to lack of efficacy http://www.newevidence.com/oncology/entries/First_Line_R_CHOP_Significantly_Improves/

  9. Randomized Withdrawal Design • Randomize participants who have tolerated and responded to the treatment to withdrawal or continuation • Useful for: • Long-term effectiveness studies • Existing population using drug in open or off-label setting http://www.sciencedirect.com/science/article/pii/S0304395910006846

  10. Study Design • Feasibility/Pilot study • Troubleshoot protocol, monitor adherence • Flexible Dose Studies • Accommodate differences in tolerability • Rescue Medication if poor response • Need strict definition of treatment failure

  11. References • Fundamentals of Clinical Research (PubH 6301) • National Research Council. (2010). The Prevention and Treatment of Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. • Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012 Oct 4;367(14):1355-60. • O'Neill RT, Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. ClinPharmacolTher. 2012 Mar;91(3):550-4.

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