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Focus Groups and Surveys The PECARN Seizure Study Community Consultation Experience

Focus Groups and Surveys The PECARN Seizure Study Community Consultation Experience. RAMPART Investigator Meeting Jill Baren, MD, MBE, FACEP, FAAP January 2008. Objectives. Describe the PECARN Seizure Study focus group and face to face survey methodologies for community consultation

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Focus Groups and Surveys The PECARN Seizure Study Community Consultation Experience

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  1. Focus Groups and SurveysThe PECARN Seizure Study Community Consultation Experience RAMPART Investigator Meeting Jill Baren, MD, MBE, FACEP, FAAP January 2008

  2. Objectives • Describe the PECARN Seizure Study focus group and face to face survey methodologies for community consultation • Provide a justification for the use of focus groups and face to face surveys as effective community consultation methods • Draw parallels between the PECARN Seizure Study and RAMPART

  3. What is PECARN? • First federally-funded multi-institutional research network in pediatric emergency medicine • 4 nodes, > 20 ED affiliates • Academic, community, urban, rural, general, and children's hospitals • Network serves approximately 800,000 acutely ill and injured children/year 

  4. PECARN Seizure Study • Two part study funded by NICHD through the BPCA mechanism • Lorazepam identified as highest priority drug for study to obtain FDA label • Study 1: Pharmacokinetics (completed) • 11 sites; 65 subjects; dose established at 0.1 mg/kg • Significant consent and enrollment barriers identified • Study 2: Randomized controlled trial of lorazepam vs. diazepam for pediatric status epilepticus • Efficacy and safety study

  5. Efficacy and Safety- the 10/30 rule • How efficacious is lorazepam compared to diazepam at stopping seizures within 10 minutes? • How efficacious is lorazepam compared to diazepam at maintaining seizure cessation at 30 minutes? • How safe is lorazepam compared to diazepam in terms of need for assisted ventilation or intubation within 4 hours of dosing?

  6. PECARN Seizure StudyRegulatory History • Negotiation with FDA/NICHD on consent issues • 18 months pre-trial activity seeking Exception from Informed Consent • Included national panel on “Emergency Research in Children: Ethical, Regulatory, and Clinical Challenges” • IND approved July ’07 using 21 CFR 50.24 regulations • Community consultation and public disclosure required as additional human subjects’ protections • Ongoing activities at all active sites (10) • Drop out of one site due to administrative denial of trial • Possible addition of another site • Full IRB approval at 3 sites • IRB approval to move forward with CC/PD at all sites • Patient enrollment beginning January ’08 with 3 sites ready

  7. Study cohorts Cohort 2: Exception from Informed Consent (SE) Cohort 1: Pre-consented during healthcare visit

  8. Study management • Co-PI structure at national level • Coordinating scientific investigator • Protocol development • Human subjects coordinating investigator • Develop and implement all aspects of regulatory process and human subjects protections • Create an overall EFIC plan • Joint activities • Steering committee leadership • IND preparation • Interface with sponsor • Trial preparation and conduct

  9. Regulatory process • IRB templated cover letter (7/06) • Initial meeting with IRB chair (9/06) • Resource binder provided • Community consultation methods discussed • IRB appointed liaison (9/06) • IRB educational sessions (12/06) • Initial protocol submission (12/06) • Requested two step approval process • Step 1: Approval of EFIC plan (1/07-3/07) • Justification for study to be carried out under 21 CFR 50.24 • Specific community consultation methods approved (1/07)

  10. IRB resource binder

  11. Regulatory process • Community consultation carried out (3/07-8/07) • IRB received report of interim results • Final IRB submission prepared including analysis of results of community consultation (9/07-11/07) • Step 2: final IRB submission (12/07) • Full committee review of community consultation results (12/07) • Full approval of scientific protocol granted (1/08) • Frequent ongoing communication

  12. Focus Group Methodology • 69 parents and patients recruited from ED, neurology clinic and inpatient floors • Trained facilitator who participated in development of topic guide • IRB liaison present at 3 of 4 focus groups • Study representative available to answer technical questions • Linked to an opt-out registry or possible prospective consent • Discussion recorded and transcribed

  13. Focus Group Results • 22 participants (31% of those recruited) • Participants generally in favor of research being performed without consent • Common themes: • Concerns about side effects • Community awareness of study • How to “opt-out” • Concerns diminished after further discussion • All adolescents expressed willingness to participate • 91% parents expressed willingness to enroll their child in study • 2 parents completed opt-out forms for clinical reasons

  14. Focus group strengths and weaknesses • In-depth qualitative method that generates detailed and rich information • Dedicated time to examine the attitudes of a small group of individuals • Selects for interested parties who are more likely to provide meaningful input • Potential for greater interaction among the participants • Generates conversation directed by the group participants • Information obtained is likely to be of high quality and useful in IRB deliberations • Diversity of information will be dictated by the composition of the groups • Cost will depend on the number conducted • Minimal to moderate in relation to overall study costs (~$1000/group)

  15. IRB response • Interim reports sent to IRB chair after each focus group • IRB liaison provided progress report during full committee meetings • Asked to conduct one additional focus group involving parents and teens without seizure disorder • Summaries and individual transcripts made available for IRB deliberations • Protocol fully approved for conduct under 21 CFR 50.24 after community consultation results reviewed

  16. Survey methods • Adults accompanying a child in the ED or neurology clinic • No requirement for complaint related to seizure in ED • Aimed to capture population where the clinical investigation will be conducted and from which the subjects will be drawn • Cost-effective way to capture group that may represent first time seizure patients • Process linked to opt-out or possible prospective consent

  17. Survey Results • 170 surveys completed • 80% of participants felt study was important and would allow their child to participate • 17 participants completed opt-out forms • Common themes • Concerns about side effects • Concern about consent process • Lorazepam not FDA approved for children • High agreement that medical research and “experiments” in emergency care are important but expressed concern about enrolling without consent • 65% felt that emergency research without consent was acceptable within their communities

  18. Survey Strengths and Weaknesses • More controllable way to disseminate information • One on one technique allows for greater interaction between the investigator and participant and avoids group bias • Time consuming and can be costly depending on personnel used • Potential for influence on the part of the survey administrator • Information produced is of moderate to high quality and likely to inform IRB deliberations • Random digit dialing telephone surveys mimic this but often do not provide two way communication unless non-study personnel know how to answer study specific questions • Less bias but do not have complete knowledge of study True intent of community consultation is two-way communication!

  19. Seizure Study/RAMPART parallels • Condition studied: Status epilepticus • Both studies compare drugs in common use, and have similar pharmacologic and adverse event profiles • Study drug comparator is unlabeled • Study population will be drawn from those who are known to have the condition as well as those developing the condition for the first time

  20. EFIC and RAMPART • Much of the rationale for conducting the PECARN Seizure Study under 21 CFR 50.24 applies to RAMPART • e.g. narrow therapeutic window of 5 min • Similar justification may be made in an overall EFIC plan • Many of the additional human subjects protections (community consultation) that have been used in the Seizure Study may be useful for RAMPART

  21. Important Lessons Learned • This is not a random process and it takes a lot of thought and time • Don’t assume that IRBs are more educated about the regulations than you are • Do not take a “one size fits all” approach • IRBs, investigators AND communities are characterized by local customs and practices • There are a huge number of misconceptions about the regulations that you must correct • Do not assume that your materials are getting the right message across

  22. Successful Strategies • Develop a plan and a strategy for global administration of the human research protections aspects of the trial • Appoint a “human subjects czar” • Investigator initiated IRB guidance through the process is essential • Investigator-IRB communication is the cornerstone of the process • Correcting misconceptions about the regulations • e.g. community consultation ≠ community consent • Pilot material and be willing to make changes based on community input (“glitch detection”)

  23. Questions?

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