flexible study design in oracle clinical and remote data capture 4.6
Post on 12-Jun-2015
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Working
with Oracle Clinical/RDC:
Flexible Study Design
Steven Rifkin
Welcome and Introduction
Steven Rifkin Chief Application Expert
• 15+ years of experience with Oracle Clinical, TMS and RDC; doing Database Design, Study Conduct and custom programming
Today’s Agenda
Time Topic
10:00-10:05 Welcome and Introduction
10:05-10:10 Who, What and Why?
10:10-10:30 Flexible Study Design Discussion and Demonstrations
10:30-10:45 Flexible Study Setup
10:45-10:55 Q&A
10:55-11:00 Wrap-up and Contact Information
Who, What and Why?
• Who is the intended audience?
– Current OC/RDC users contemplating an upgrade to version 4.6
– New users of OC/RDC 4.6 who want to learn more about flexible study design
– Non-OC/RDC users evaluating the features of the application who perhaps previously reviewed an earlier OC/RDC version
Who, What and Why?
• What features are we examining today?
– Demonstrate a flexible study showing ability to enable or disable entire forms or visits based on data responses
– Setting up a Flexible Study via an Enhanced DCI Book
Who, What and Why?
• Why are these features important?
– Organizations need the ability to create a study schedule which is flexible for more complex clinical trials
– Especially important when the sites will perform the entry in an EDC system so that users are presented only with the forms/visits they need
Flexible Study Design …
• Prior to Release 4.6, Oracle Clinical required strict sequential navigation through a set of Clinical Planned Events in a DCI book
• Some trials require complex (or flexible) studies with multiple treatment arms with different patient groups receiving different assessments
– Common for Oncology trials
Flexible Study Design
• Release 4.6 allows multiple pathways to be defined in a single DCI Book using conditional logic based on data for a specific patient
– Logic will make a new set of visits and CRFs expected for the patient
• The RDC Onsite interface now has a dynamic display of newly expected visit and CRF data as patient data is entered
Example Study
Screening Completion
A:Cycle 2 A:Cycle 3 A:Cycle 1
B:Cycle 2 B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Rules for Example Study
1. Until any data for Demography form is entered, only the Screening Visit is expected; after demography data, the Completion and AE Log visits are expected
2. The Enrollment CRF during the screening Visit will determine and schedule the Cycle 1 visits in either Arm A or Arm B
3. Response to a question during Interim Visit in a cycle with schedule next cycle or end the study for subject
4. If treatment not given during any treatment visit, subject will leave the study
5. If treatment is given, a new expected form is added for the visit
Example Study: Rule 1
Screening Completion
A:Cycle 2 A:Cycle 3 A:Cycle 1
B:Cycle 2 B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Only the Screening Visit is expected until data entered on the Demography
form. Demog entry will enable the Completion Visit and the AE Log
Flexible Study Design
Demonstration
Example Study: Rule 2
Screening Completion
A:Cycle 2 A:Cycle 3 A:Cycle 1
B:Cycle 2 B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Enrollment CRF specifies if Patient is in Arm A or Arm B and schedules cycle 1 treatments
Flexible Study Design
Demonstration
Example Study: Rule 3
Screening Completion
A:Cycle 2 A:Cycle 3 A:Cycle 1
B:Cycle 2 B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
YES to “continue to next cycle” in any Interim Visit will schedule the next Treatment Cycle
NO to “continue to next cycle” in any Interim Visit bypass remaining cycles
Flexible Study Design
Demonstration
Example Study: Rule 4
Screening Completion
A:Cycle 2 A:Cycle 3 A:Cycle 1
B:Cycle 2 B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
NO to “give treatment” in any treatment will bypass remaining visits and cycles
Flexible Study Design
Demonstration
Example Study: Rule 5
YES to “should drug be given” in any treatment will
schedule a new form to be completed at the visit
HEMATOLOGY FORM
Should Drug be given?
Yes
INFUSION FORM
Flexible Study Design
Demonstration
Setup of a Flexible Study
1. Identify the Study as Flexible during initial study setup to set the Clinical Study State
2. Define Intervals and Clinical Planned Events for the study
3. Set up “Enhanced” DCI Book with DCI Book Rules
Creating a Flexible Study
Conduct Security Clinical Study States
Intervals
• An Interval is a time span in which there are one or more visits (Clinical Planned Events)
• Types of Intervals – Phase – Periods – Sub-periods
Modeling the study will involve placing visits in specific Intervals • Need to plan since visits in an interval will be enabled by logic in Flex
Study Design
Phase
Period
Sub-Period
Intervals
Modeling Intervals
Periods
Treatment
Phase
Completion
Phase Screening
Phase Logs
Phases
Sub-periods
Arm A Arm B
A: Cycle 1 A: Cycle 3 A: Cycle 2 B: Cycle 1 B: Cycle 2
indicate intervals where visits (CPEs) will be placed
Each Interval must have a unique name
Defining Intervals
Intervals are defined from the Easy Study Design Screen
Design Studies Easy Study Design
Defining Clinical Planned Events …
• Each Clinical Planned Event used in your study must be defined and associated with an Interval (Phase, Period or Sub-period)
• Each CPE in the study must have a unique name – use a shorthand to indicate parent phase, period and sub-period – Treatment 1 visit is defined in multiple intervals
• Visit for Treatment Phase, Arm A, Cycle 1 named AC1 TREATMENT 1
• Visit for Treatment Phase, Arm A, Cycle 2 named AC2 TREATMENT 1
• Visit for Treatment Phase, Arm B, Cycle 1 named BC1 TREATMENT 1
• Visit No. field reflects the sequence in the schedule and will not reflect the actual sequence of events for a patient
• Duration fields are required but have no effect on the flexible study definition
Enhanced DCI Books …
• Function for Enhanced DCI Books has four sections – Navigator: Display screen listing the visits
defined for the study and the interval to which each is assigned
– Constraints: Limit the unplanned use of specific DCIs (no change from earlier versions)
– Interval Rules: Define when an interval and its associated visits and DCIs will become expected
– DCI Rules: Define when a specific DCI becomes expected in a visit or over all visits
27
Enhanced DCI Books
Definition DCIs Enhanced DCI Books
Buttons will be disabled for non-flexible studies
Enhanced DCI Books: Navigator …
Definition DCIs Enhanced DCI Books, [Navigator]
This column will be blank
for non-flexible studies
Select a Visit and click [DCI Book Pages for CPE]
to define which DCIs are expected for that Visit
Counts will update
dynamically as DCIs are
added to Visits and
Rules defined
CPE and Intervals are
pre-populated with
Events for the Study
Enhanced DCI Books: Navigator …
Definition DCIs Enhanced DCI Books, [Navigator], [DCI Book Pages for CPE]
Enter (or select with LOV) a DCI that may be
expected at this Visit
Use the buttons to
change the Visit to
which DCIs will be
assigned
Enhanced DCI Books: Rules
• Book Rules are available only for Flexible Studies
• Rules apply to all patients to which the book is assigned
• Interval Rules enable an interval and the visits within the intervals
• DCI Rules enable a specific DCI
– DCI within the current visit
or
– DCI across all visits in which the DCI is defined
• Rules determine “expectedness”
Enhanced DCI Books: Interval Rules
• All Intervals are considered enabled unless a target of an Interval Rule
• Interval Rules are specified for a specific DCI – will apply to all visits where the DCI is entered
• Triggers at a DCI determine if an interval is enabled – Trigger Conditions
• Trigger an interval when any data is entered in the DCI
• Trigger an interval when there is a specified response to a question
– Trigger Actions • Enable one or more named target intervals
• Enable Next Interval
• Bypass to a specified target interval
Enhanced DCI Books: Rules
Prior to definition of any Book Rules all DCIs in all
CPEs in all intervals will appear in the RDC surround
Enhanced DCI Books: Interval Rules …
Definitions DCIs Enhanced DCI Books, [Interval Rules]
RULE: Enable the Completion and Logs Intervals if any data is entered on Demography
Enhanced DCI Books: Interval Rules …
Before Demography Entered:
Completion and Logs Intervals
do not appear -- they are now
Targets of Rules
Enhanced DCI Books: Interval Rules …
After Demography Entered:
Completion and Logs Intervals
appear -- the Interval Rule
enables them
Treatment intervals still appear
because these are not yet targets
of an interval rule!
Enhanced DCI Books: Interval Rules …
Definitions DCIs Enhanced DCI Books, [Interval Rules]
RULE: enable the “A Cycle 1” Interval or the “B Cycle 1” Interval dependent
on the Arm assigned on Enrollment DCI
Enhanced DCI Books: Interval Rules …
Before Enrollment DCI is completed, no visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be present because both intervals are now targets
Enhanced DCI Books: Interval Rules …
When Enrollment DCI is completed, the visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be added as enabled
Enrolled in A Arm
Enhanced DCI Books: Interval Rules …
RULE: At last (INTERIM) visit for any cycle, if response to the NEXT_CYCLE_YN
question is NO, bypass to the COMPLETION Interval; if response is YES, then
enable the next sequential interval
Enhanced DCI Books: Interval Rules …
Without DEMOGRAPHY, only Screening Interval is enabled since use of [Next Interval] at
the end of all cycles makes each treatment cycle a target of a rule
Enhanced DCI Books: Interval Rules …
With DEMOGRAPHY, Completion and Logs Intervals are enabled
Enhanced DCI Books: Interval Rules …
If Enrolled in Arm A, Cycle 1 for Arm A enabled
Enhanced DCI Books: Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify YES to continue to next cycle --
and Arm A Cycle 2 Visits are enabled
Enhanced DCI Books: Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify NO to continue to next cycle --
and Arm A Cycle 2 Visits are not enabled: bypassed other cycles
Enhanced DCI Books: Interval Rules …
At INTERIM Visit for Cycle 2, specify YES to continue to next cycle --
and Arm A Cycle 3 Visits are enabled
Enhanced DCI Books: Interval Rules
At AC1 Treatment 2, Dose was not given. Only Visits in the Completion and Logs
Intervals are enabled; Visits after the current visit in the current interval are disabled!
Enhanced DCI Books: DCI Rules …
• Within an Interval, rules can be defined to enable specific DCIs in the visit or across all visits which contain that DCI
– Only DCIs which contain one or more questions associated with a DVG can be have DCI rules
Enhanced DCI Books: DCI Rules …
RULE: At a Treatment Visit, if the Dose is given (GIVE_DOSE_YN=YES) then an
infusion form must be made “expected” in that visit
Enhanced DCI Books: DCI Rules
Before GIVE_DOSE_YN was completed,
no INFUSION form expected at visit
After GIVE_DOSE_YN was completed, an
INFUSION form is expected at visit!
Q&A
Closing
Thank you for attending!
This webinar will be posted on www.biopharm.com
within 24 hours
Contact BioPharm
United States: +1 877 654 0033 United Kingdom: +44 (0) 1865 910200
Email Address: info@biopharm.com
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