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Uterine Fibroids Program Status

  • Uterine Fibroids Program Status

  • Eligibility and Delayed Randomizations

  • Result Flags and Alerts

  • Responding to Queries and Alerts

  • Entering Subject Data in EDC

  • Pregnancies

  • Processing Subject Referrals

  • Recruitment and National Media Campaign

  • Open discussion











Assess eligibility throughout the Screening Period and just prior to dosing

  • Assess eligibility throughout the Screening Period and just prior to dosing

  • Ensure that all required screening procedures have been completed and/or required reports have been received (including final ultrasound eligibility report, mammogram report, any repeat procedure reports, etc.)

  • Randomizing subjects before all screening results are available may result in:

      • Withdrawal of subject from the study
      • May pose a safety risk to your subjects
      • Extra work for you and your staff
      • May pose a regulatory/audit risk
  • Key procedures/assessments results that must be confirmed prior to randomizing:

    • Final Eligibility Report: For subjects meeting eligibility based on ultrasound and SIS; your site will receive both a Preliminary Imaging and a Final Imaging Report. You must obtain a Final report prior to randomization
    • Mammogram Results: Only subjects with BIRADS 1, 2 or 3 are eligible. BIRADS 0 indicates that additional work-up must be performed, and BIRADS 4, 5 and 6 are exclusionary. See Please consult Protocol, Section 5.3.1.1, Mammogram, for further details.
    • DXA Results: Only subjects with T-scores > -1.5 in all three regions are eligible. to be randomized into the study. You must have a qualifying DXA report prior to randomization
    • Repeat lab analytes


Nearly 50% of all eligible subjects have delayed randomizations because eligibility cannot be established

  • Nearly 50% of all eligible subjects have delayed randomizations because eligibility cannot be established

    • Delays are usually a result of:
      • Pending results from required repeat testing such as mammogram, endometrial biopsies, SIS, DXA and/or ultrasound
      • Vendor/Abbvie queries and lab alerts are not responded to in a timely manner
      • Scheduling difficulties with mammogram, DXA, Ultrasound
    • To avoid delays:
      • Ensure key procedures with longer turn-around-times for results or scheduling do not become a factor and are conducted early in the screening process, typically no later than the completion of Screening Product Collection Visit 2
      • Respond to queries within 24 hours of receipt
    • Delays in randomizing subjects can affect Subject motivation and is an inconvenience to them


Queries are generated throughout the study, including Screening

  • Queries are generated throughout the study, including Screening

  • This is one key form of communication between AbbVie, its Vendors and You

  • Please respond to queries in a timely manner, otherwise may:

      • Delay final study reports/results
      • Delay randomization
      • Delay screen-failing an ineligible subject
        • Could result in randomizing ineligible subjects
      • Impact the ability to offer subjects access to the trials
    • Please ensure that you and your staff respond to queries within 24 hours of receipt


Electronic data capture (EDC): The following subject data must be entered into EDC after having received results from Screening Product Collection Visit 1 and the ultrasound (or other imaging) shows qualifying fibroid(s):

  • Electronic data capture (EDC): The following subject data must be entered into EDC after having received results from Screening Product Collection Visit 1 and the ultrasound (or other imaging) shows qualifying fibroid(s):

  • All data must be entered into EDC prior to randomization to confirm eligibility





Information you may find on your report

  • Information you may find on your report





There is an increase in the number of positive serum beta-hcg test results above the total number of positive serum beta-hcg test results in the prior Phase 2b study

  • There is an increase in the number of positive serum beta-hcg test results above the total number of positive serum beta-hcg test results in the prior Phase 2b study

  • The Elagolix Pregnancy Prevention Information and Counseling Program (EPPIC) is a key part of these studies

  • Please ensure that you and your study staff take the time to:

      • Assess a potential subject’s understanding and willingness to use two forms of non-hormonal contraception throughout the Screening Period;
      • Educate and remind subjects of the importance to use two forms of non-hormonal birth control consistently throughout their participation
      • The time and efforts taken to educate and prevent pregnancies from Screening through Post-treatment Follow-up keep your patients safe and are critical to the success of the Uterine Fibroids Program.




AbbVie has a goal to randomize 50% (400 subjects) across both studies by the end of 2016. We need your help to meet this goal, and ask that you:

  • AbbVie has a goal to randomize 50% (400 subjects) across both studies by the end of 2016. We need your help to meet this goal, and ask that you:

  • Contact referrals within 48 hours (or work with 3-Wire to contact on your behalf)

  • Schedule referrals or your patients to attend the initial visit as early in the month of October as possible

      • Consider hosting an Open House Learning Forum ( multiple referrals/patients come to your Site and hear about the Study at the same time; presentation slides are available upon request)
    • Update the status in IRT and Continuum’s Subject Status Tracker (or work with your Site Optimization Specialist or 3-Wire to update on your behalf)
      • Timely updates allows us to project overall recruitment




National Recruitment campaign was launched September 12, 2016

  • National Recruitment campaign was launched September 12, 2016

  • To date, the National Campaign has generated:

      • Approx 72,000 enquiries
      • 13,000 Site Referrals
      • 1,500 Consented Subjects
      • 74 Randomized Subjects
  • It is important that referrals to your Site are contacted within 48 hours, to prevent loss of interest

  • Do You Need Help? 3-Wire is available to assist with:

      • Contacting Referrals
      • Scheduling Referrals (you provide time slots of availability)
      • Following-up on No-Shows or Call-Backs
      • Updating Continuum’s Reporting Trackers
  • Continuum and AbbVie are also looking into local-targeted advertising/support for Sites that have not received many referrals, yet have the capacity

      • Contact the Study Manager for further Information)


National Recruitment campaign was launched September 12, 2016

  • National Recruitment campaign was launched September 12, 2016

      • National Campaign consists of TV, Radio, Facebook, Google advertisements
  • To see our ad, go to the study website: www.myfibroidstudy.com

  • TV Stations and Broadcast Programs where you may see our ads:








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