ZEDS Coordinators Conference Call May 30, :00 AM EDT

Transcription

1 ZEDS Coordinators Conference Call May 30, :00 AM EDT Participating Clinical Centers (PCC): Status Updates Centers Green Lighted for Screening and Randomization N=56 Study Participants Screened N=93 Study Participants Randomized N=67 32 Centers with Patient Activity 24 Centers with No Patient Activity 2 1

2 3 Duplicate Screening When a participant is registered at Visit 1/screen a unique ID is assigned in Parexel. When the participant comes back for Enrollment/Randomization Visit 2, please do not create a new participant. Instead click on Take a Visit 4 2

3 ClinPhone Alerts and Warnings: Initiating a Participant After entering the Date of Birth, Sex, Onset of HZO, and Informed Consent date, the system allows you to review the data before submitting the entry. Verify the data entered is correct, then click SUBMIT. If Not, click the Back arrow, make necessary changes, click NEXT, review your changes and click SUBMIT if changes are correct. 5 ClinPhone Alerts and Warnings: Enrolling a Participant From the Participant Management tab, select the Participant ID Number who is to be enrolled. 6 3

4 Follow Up Visits When a participant is coming for a follow up visit make sure that you follow the correct sequence and answer question correctly: Pick the correct participant Take a visit: Enter DOB and sex Enter Visit details For the following question: Are you entering a prior visit where no medication was dispensed? Answer is no if the previous visit was a regular follow up visit. If yes is answer no medication will be dispensed 7 ClinPhone Alerts and Warnings: Avoiding Duplicate Participants 8 4

5 ClinPhone Alerts and Warnings: Potential patients who have been pre-screened are not submitted into ClinPhone DO NOT RUSH! Read any warning messages and alerts that pop up. Carefully review the data before clicking on the submit button. Potential patients who have been pre-screened are not submitted into ClinPhone A record of these patients should be kept in your screening logs 9 Endpoints An Endpoint is the primary outcome that is being measured in a clinical trial. Primary endpoints measure outcomes that will answer the primary (or most important) question being asked by a trial Secondary endpoints are those that provide supportive information The primary endpoint in ZEDS is the time to first occurrence of new or worsening episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO, requiring pre-specified changes in treatment during the twelve months of treatment. The primary endpoint is compared for participants randomized to study medication or placebo. 10 5

6 Endpoints Why is it important to submit endpoints in TrialMaster? All suspected endpoints occurring after randomization are reviewed by the ZEDS Clinical Event Review Committee. Two members of the committee are randomly selected for the review. If the two members disagree, the committee chair will review the data. In addition to the data in TrialMaster, the medical records may also be reviewed. Carlos will request the redacted medical records. 11 Primary Endpoints - Definitions Stromal Keratitis WITHOUT ulceration: Localized or diffuse stromal infiltrates with or without keratic precipitates, corneal edema, or corneal neovascularization, and is without an epithelial defect by fluorescein staining. Endothelial Keratitis: Disciform (localized) or diffuse corneal stromal, and usually epithelial edema, with keratic precipitates out of proportion to anterior chamber reaction (none or trace: 5 cells or less per field). Iritis: Anterior chamber reaction graded 1+ (6 or more cells/field using 1x1mm slit beam) in the absence of suspected or proven microbial keratitis. Stromal Keratitis WITH ulceration: Stromal infiltrates with an overlying epithelial defect by fluorescein staining due to active stromal keratitis and not neurotrophic keratopathy or suspected or proven microbial superinfection. Microbial superinfection should be ruled out by negative corneal smears and cultures and/or lack of response to intensive antibiotic treatment every one hour. Dendriform Epithelial Keratitis: Linear or elongated, often branching lesion(s) on the corneal surface that stain at least minimally with fluorescein. They are usually elevated, non-ulcerated, and without terminal bulbs. 12 6

7 Primary Endpoints - Diagnosis 13 Primary Endpoints Treatment Requirements for DEK 14 7

8 Primary Endpoints Treatment Requirements for SK, SKU, EK or IR 15 Primary Endpoints Case Example Enrollment Visit 3-month Follow-up Prednisolone acetate 1% 2x/day Prednisolone acetate 1% 4x/day 16 8

9 Primary Endpoints Submitting Data in TrialMaster Required Forms Ophthalmic Exam 17 Primary Endpoints Submitting Data in TrialMaster 18 9

10 Primary Endpoints Submitting Data in TrialMaster Required Forms HZO Treatment 19 Primary Endpoints Submitting Data in TrialMaster Required Forms Endpoint Form 20 10

11 Primary Endpoints Adjudication Process 21 Primary Endpoints Adjudication Process 22 11

12 Primary Endpoints Adjudication Process Review Package The two CERC members randomly chosen to review the suspected endpoint will receive: Copies of the required CRFs Primary Endpoint Review Report (PERR) Any source documents, as required 23 Primary Endpoints Clinical Event Form 24 12

13 Updates and Reminders ClinPhone Programming Updates HZO onset date will not accept years prior to 2000 Comparison of HZO onset date to DOB Study medication dispensing Verify correct bottle number Complete the SMA form in TrialMaster immediately 25 Updates and Reminders Central IRB Continuing review approval received May 9, 2018 PCCs received a notification from IREx Administrator Print out copies of the approval letter and new ICF Begin using ICF with the new expiration date immediately Discard any extra copies of the expired ICF MOP Protocol 2.0 revisions have been incorporated Roll out June 4,