Importance of Timely Data Submission

Transcription

1 Importance of Timey Data Submission Shauna Himan Mayo Cinic CRP Information Session, November 2 nd, 2017

2 Presentation Objectives Iustrate the importance of data submission timeiness Communicate the status of Aiance data submission timeiness Remind users of toos avaiabe to hep manage data submission

3 Importance of Timey Data Submission The most important reason we need timey data submission is to protect the we being of our patients!

4 Data Monitoring Mechanisms Safety Monitoring Adverse events SAE AE rate Efficacy Monitoring Interim anayses Routine Reporting NCI via CDUS reporting (quartery), DSMB (biannua), CIRB (yeary) Data Reviews Eigibiity Case evauations

5 Monitoring Data Safety and Monitoring Board (DSMB) Meets biannua to review the safety and efficacy of tria data and makes recommendations about the timing of tria cosure and reease of study data to the sponsor and pubic In order to review safety and efficacy data, data needs to be reativey compete There are inherent biases in the rate data comes in Exampe, events (deaths) are typicay reported more quicky than non events, thus if data is not compete decisions may be impacted

6 Safety Monitoring AE Stopping rues Aiance trias incude Adverse Event stopping rues Exampe from A091302: If at any time, 3 of the initia 10 treated patients or 30% or more of a patients (i.e. when accrua is greater than 10 patients) have experienced a grade 4 adverse event. To assess whether an AE stopping rue has or has not been met, timey AE data is needed

7 Safety Monitoring CTEP-AERs Rave Integration The main goa of the integration is to synchronize the safety and routine AE databases and provide a recommendation about whether an AE does or does not need to be reported in an expedited fashion In order to provide the recommendation, the key eements of an AE need to be entered in rea time If a site is behind on their data entry and they want to report an SAE, they wi need to ro out foders to get to the current cyce of treatment

8 Routine Reporting Cinica Data Update System (CDUS) CDUS reporting is the primary resource of cinica tria data for the NCI to fufi their reguatory, scientific and administrative needs. For NCIs monitoring to be meaningfu, data needs to be compete and accurate Submitted quartery and a identified errors must be resoved for the report to be accepted Exampe of an error: If an AE is reported on a cyce and there is no treatment information corresponding to that cyce

9 Centra Monitoring Required by NCI for a trias where CTEP hods the IND Source documentation is submitted so that a centra monitor can verify key tria data in rea time Key tria data Eigibiity, first 2 cyces of treatment, off treatment, endpoints

10 Data Reviews in Rea time Main goa to identify and correct any data issues quicky and before errors are repeated in subsequent cyces and future patients

11 Eigibiity Review Eigibiity reviews are conducted in rea time by Data Managers and Study Chairs Data Managers are fagged to perform an eigibiity review when a required forms and source documentation are entered within Rave Eigibiity reviews done in rea time Aows study teams to identify areas of the eigibiity criteria that are confusing or require further education before trias are negativey impacted by high rates of ineigibiity

12 Case Evauations Case Evauations are conducted in rea time by Data Managers and Study Chairs Data Managers are fagged to perform a case evauation when a tria endpoint has been reported in Rave Progression, death, ost to foow-up, withdrawa of consent, foow-up competed Case evauations done in rea time Aows study teams to identify issues with data coection or endpoint determination that can then be corrected before having negative impact on tria outcomes

13 Efficacy Monitoring Interim anayses are pre-specified in the protoco and often occur when a given number of events (such as progression) have been reported For fast accruing trias it is especiay important to receive timey data submission so an interim anaysis evauating endpoint data can be conducted before accrua goas have been met

14 Tria Exampes Tria A021501: Rapid accrua There is a choice between Stereotactic Body Radiation Therapy (SBRT) and Hypofractionated image guided radiation therapy (HIGRT) but it is critica to the tria resuts to ensure a arge % of pts receive SBRT Concern: Competing enroment ony to find when data is received that the needed % of SBRT pts was not met

15 Tria Exampes Tria A021202: Patients go off treatment based on centra review of recurrence Since treatment is impacted based on review it is critica for data to be entered in rea time to support the centra review of recurrence

16 Aiance Data Timeiness

17 Aiance Data Timeiness Institutiona Performance Evauation Committee (IPEC) A number of Aiance sites are at risk for probation at the next group meeting for having their third consecutive evauation with a -2 score in data submission timeiness < 75% of data submitted on time

18 Aiance Data Timeiness There are toos to hep! Overdue Materia Reports on the Aiance website Data Quaity Porta on the CTSU website Note: Data submission timeiness data is now avaiabe to NCI across a cooperative groups Rave Task Summary

19 Overdue Materia Tracking Do NOT respond to queries about missing data by indicating pending or cyce not compete The query is a reminder that data is sti needed

20 Take Home Message Timey Data submission is critica to the success of the Aiance reasons incuding: Safety and efficacy monitoring to protect our patients DSMB, CDUS, CIRB reporting to fufi reguatory requirements Eigibiity and case eva reviews to identify potentia data issues and correct them as quicky as possibe The Aiance needs to improve its data submission timeiness There are toos to hep