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NCI Trial Complexity NCI Trial Complexity Elements & Scoring Elements & Scoring
ModelModel
A Step by Step Overview of A Step by Step Overview of Scoring a Cooperative Group Scoring a Cooperative Group
TrialTrialUpdated April 16, 2009
Background InformationBackground Information
Improve Cost-Effectiveness and Accrual RatesImprove Cost-Effectiveness and Accrual Rates Speed Trial Initiation at SitesSpeed Trial Initiation at Sites
In 2005, the National Cancer Advisory Board’s Clinical Trials Working Group Report, Restructuring the National Cancer Trials Enterprise, recommended several Operational Efficiency Initiatives, including:
http://integratedtrials.nci.nih.gov/ Final CTWG report to the National Cancer Advisory Board, “Restructuring the National Cancer Clinical Trials Enterprise”
Background Information Background Information (continued)(continued)
Align reimbursement with trial complexity as one Align reimbursement with trial complexity as one component for an improved funding modelcomponent for an improved funding model
Develop a simple, standardized model to score Develop a simple, standardized model to score various trial elements that are related to the most various trial elements that are related to the most time-consuming tasks at participating sitestime-consuming tasks at participating sites
Some objectives of the Operational Efficiency Initiative included:
Background Information Background Information (continued)(continued)
A Working Group consisting of staff from the Cooperative Groups and the NCI was formed to
address the trial complexity recommendation
Ten elements were identified and included in the complexity model and scoring system
Studies deemed complex per this scoring may be eligible to receive additional funds (beyond the base capitation)
Trial Complexity Elements
Element Title# 1 # of Study Arms
# 2 Informed Consent Process
# 3 Registration or Randomization Steps
# 4 Complexity of Investigational Treatment
# 5 Length of Investigational Treatment
# 6 Feasibility & Personnel Impact
# 7 Data Collection Complexity
# 8 Follow-up Requirements
# 9 Ancillary Studies
# 10 Participant Feasibility & Enrollment
•Elements subdivided into standard, moderate, or high levels of complexity
Scoring System for the Trial Complexity Model
Element Title Standard/ Moderate High
Level
# 1 # of Study Arms Standard
# 2 Informed Consent Process Moderate
# 3 Registration or Randomization Steps High
# 4 Complexity of Investigational Treatment
Standard
# 5 Length of Investigational Treatment Moderate
# 6 Feasibility & Personnel Impact High
# 7 Data Collection Complexity Standard
# 8 Follow-up Requirements Moderate
# 9 Ancillary Studies High
# 10 Participant Feasibility & Enrollment Standard
Trial: X
0
1
2
1
1
0
0
0
2
2
Final Trial Complexity Score = 9
More Detailed Explanation of Model
Each of these elements are defined in detail in the following slides
The model is further illustrated using NSABP-B40 as an example
The Trial ElementsThe Trial Elements
Element # 1 – Number of Study ArmsElement # 1 – Number of Study Arms
Level 0 – (standard): 1-2 study armsLevel 0 – (standard): 1-2 study armsLevel 1 – (moderate): 3-4 study armsLevel 1 – (moderate): 3-4 study armsLevel 2 – (high): >4 study armsLevel 2 – (high): >4 study arms
ScoreScore001122
The Trial ElementsThe Trial Elements
Element # 2 – Informed Consent ProcessElement # 2 – Informed Consent Process
Level 0 – (standard):Level 0 – (standard):- Straightforward- Straightforward- 1-step randomization- 1-step randomization- Standard of Care vs. Investigational- Standard of Care vs. Investigational
Level 1 – (moderate):Level 1 – (moderate):- Simple trial with placebo arm- Simple trial with placebo arm- Observation only arms- Observation only arms- 2-step rando/registration- 2-step rando/registration- Requires assent process- Requires assent process
Level 2 – (high):Level 2 – (high):- Highly complex to explain to pts- Highly complex to explain to pts (predictive markers, crossover, extra (predictive markers, crossover, extra mandated consents/tests forms) mandated consents/tests forms)- Multiple steps / randomizations- Multiple steps / randomizations- Intra-operative randomization- Intra-operative randomization
00
11
22
ScoreScore
NSABP-B-40
Element 1 > 4 arms, Therefore, Score = 2
Element 2 Simple & 1-
step, Therefore,Score = 0
The Trial ElementsThe Trial Elements
Element # 3 – Registration or Randomization StepsElement # 3 – Registration or Randomization Steps
Level 0 – (standard):Level 0 – (standard):- 1-step registration / randomization- 1-step registration / randomization
Level 1 – (moderate):Level 1 – (moderate):- Separate registration / randomization- Separate registration / randomization- Central pathology review- Central pathology review
Level 2 – (high):Level 2 – (high):- Multiple steps / randomizations- Multiple steps / randomizations- Intra-operative randomization- Intra-operative randomization- Complex central path review prior to- Complex central path review prior to randomization (ie. tumor genotyping) randomization (ie. tumor genotyping)
00
11
22
ScoreScore
The Trial ElementsThe Trial Elements
Element # 4 – Complexity of Investigational TherapyElement # 4 – Complexity of Investigational Therapy
Level 0 – (standard):Level 0 – (standard):- outpatient, single modality- outpatient, single modality- similar to standard of care- similar to standard of care
Level 1 – (moderate):Level 1 – (moderate):- combined modality- combined modality- conventional chemo + biologics- conventional chemo + biologics- simple inpatient treatments- simple inpatient treatments
Level 2 – (high):Level 2 – (high):- therapy with high risk of toxicity- therapy with high risk of toxicity (eg. gene transfer, stem cell tx) (eg. gene transfer, stem cell tx)- special credentialing required - special credentialing required
ScoreScore
00
11
22
NSABP-B-40
Element 3Pre-rando
Path Review, Therefore, Score = 2
Element 4 Combination
modality, Therefore,Score = 1
The Trial ElementsThe Trial Elements
Element # 5 – Length of Investigational TreatmentElement # 5 – Length of Investigational Treatment
Level 0 – (standard):Level 0 – (standard):- regimens with defined # of cycles- regimens with defined # of cycles- routine/standard hormonal therapy - routine/standard hormonal therapy
Level 1 – (moderate):Level 1 – (moderate):- lengthy regimens (until progression)- lengthy regimens (until progression)- long hormone &/or maintenance rx- long hormone &/or maintenance rx (in addition to investigational agent) (in addition to investigational agent)
Level 2 – (high):Level 2 – (high):- extended investigational treatment- extended investigational treatment (eg. >6 mos, or q21 days x 22 cycles) (eg. >6 mos, or q21 days x 22 cycles)
ScoreScore
00
11
22
The Trial ElementsThe Trial Elements
Element # 6 – Feasibility & Personnel ImpactElement # 6 – Feasibility & Personnel Impact
Level 0 – (standard):Level 0 – (standard):- 1 typical research team- 1 typical research team- one discipline- one discipline
Level 1 – (moderate):Level 1 – (moderate):- moderate number of med disciplines- moderate number of med disciplines
Level 2 – (high):Level 2 – (high):- high number of disciplines needed- high number of disciplines needed- > 2 disciplines with significant need- > 2 disciplines with significant need for complex coordination of activities for complex coordination of activities
ScoreScore
00
11
22
NSABP-B-40
Element 5Extended
invest. agent >6 mos,
Therefore, Score = 2
Element 6 Multi-
disciplines, surg/chemo/pat
h radiology Therefore,Score = 2
The Trial ElementsThe Trial Elements
Element # 7 – Data Collection ComplexityElement # 7 – Data Collection ComplexityLevel 0 – (standard):Level 0 – (standard):
- standard AE reporting- standard AE reporting- prospective, standard regulatory data- prospective, standard regulatory data- adjuvant study with standard CRFs- adjuvant study with standard CRFs
Level 1 – (moderate):Level 1 – (moderate):- specific AE reported expedited means- specific AE reported expedited means- retrospective addt’l regulatory data- retrospective addt’l regulatory data- prospective addt’l reg data (labs norm)- prospective addt’l reg data (labs norm)- additional data (eg. concomitant meds)- additional data (eg. concomitant meds)- RECIST criteria- RECIST criteria- multiple step study- multiple step study
Level 2 – (high):Level 2 – (high):- real time reporting of AE (> AdEERS)- real time reporting of AE (> AdEERS)- real time data reporting- real time data reporting- signif data under a SPA / registration trial- signif data under a SPA / registration trial- complex hematological- complex hematological- retro/prospect scan collection- retro/prospect scan collection- central imaging review dictates rx decisions- central imaging review dictates rx decisions
00
11
22
ScoreScore
The Trial ElementsThe Trial Elements
Element # 8 – Follow-up RequirementsElement # 8 – Follow-up Requirements
Level 0 – (standard):Level 0 – (standard):- payment for follow-up data (Tier 1)- payment for follow-up data (Tier 1)- up to 2 years follow-up- up to 2 years follow-up
Level 1 – (moderate):Level 1 – (moderate):- payment for follow-up data (Tier 2)- payment for follow-up data (Tier 2)- 2 to 5 years follow-up- 2 to 5 years follow-up
Level 2 – (high):Level 2 – (high):- payment for follow-up data (Tier 3)- payment for follow-up data (Tier 3)- greater than 5 years follow-up- greater than 5 years follow-up- requiring rx and toxicity data for pts- requiring rx and toxicity data for pts off study / post disease progression off study / post disease progression
ScoreScore
00
11
22
NSABP-B-40
Element 7RECIST
measurements, Therefore,
Score = 1
Element 8 > 5 yrs,
complex scans Therefore,Score = 2
The Trial ElementsThe Trial ElementsElement # 9 A and B – Ancillary StudiesElement # 9 A and B – Ancillary StudiesLevel 0 – (standard):Level 0 – (standard):
- no studies- no studies- Ancillary / Correlative Science (Tier 1)- Ancillary / Correlative Science (Tier 1)- Ancillary Tiers for HRQOL, Ca Control,- Ancillary Tiers for HRQOL, Ca Control, Health Services or other (Tier 1) Health Services or other (Tier 1)
Level 1 – (moderate):Level 1 – (moderate):- Ancillary Tiers for Correlative Science - Ancillary Tiers for Correlative Science (Tier 2, 3 I & II) (Tier 2, 3 I & II)- Ancillary Tiers for HRQOL, Ca Control,- Ancillary Tiers for HRQOL, Ca Control, Health Services or other (Tier 2/3) Health Services or other (Tier 2/3)
Level 2 – (high):Level 2 – (high):- Ancillary Tiers for Correlative Science - Ancillary Tiers for Correlative Science (Tier 2, 3 III & 4) (Tier 2, 3 III & 4)- Ancillary Tiers for HRQOL, Ca Control,- Ancillary Tiers for HRQOL, Ca Control, Health Services or other (Tier 4) Health Services or other (Tier 4)
11
22
ScoreScore
For a description of the Ancillary Tiers, please visit: http://ctep.cancer.gov/protocolDevelopment/docs/tier_ancillary_studies.pdf
00
The Trial ElementsThe Trial Elements
Element # 10 – Participant Feasibility & EnrollmentElement # 10 – Participant Feasibility & Enrollment
Level 0 – (standard):Level 0 – (standard):- target population routinely seen- target population routinely seen
Level 1 – (moderate):Level 1 – (moderate):- target population is uncommon cancer- target population is uncommon cancer- target is common ca, but rare trials for- target is common ca, but rare trials for- trial has highly selective eligibility- trial has highly selective eligibility (eg. molecular screening criteria) (eg. molecular screening criteria)
Level 2 – (high):Level 2 – (high):- target population includes groups often - target population includes groups often underrepresented (elderly, minorities) underrepresented (elderly, minorities)
ScoreScore
00
11
22
NSABP-B-40
Element 9Moderate, Tier
2/3 on the Ancillary Tiers,
Therefore, Score = 1
Element 10 Moderate molecular screening, Therefore,Score = 1
Enter the Complexity Score in Section 7 of the
PSW
Please note: in the event that a study amendment significantly alters a trial design, an updated complexity
score can be submitted.
PSW at: http://ctep.cancer.gov/protocolDevelopment/docs/psw.pdf
Authors of the ModelACOSOG
Beth Martinez
CALGBKathy KarasMary Sherrell
COGMaura O’Leary
CTSUMartha HerringKaren KolbeRuth LamberskyDonna MarinucciSteve Riordan
ECOGMary SteeleDeb Strandberg
GOGLarry CopelandKia NeffLaura ReeseMary SharpBetty Stonebraker
NCCTGAimee FjelstadDesirae Sagdalen
NCICBelinda Vandersluis
NSABPWalt CroninBarbara HarkinsDonna Szczepankowsi
RTOGTom Wudarski
SWOGAbbie BrownNathan EriksenMarj GodfreyJoy ReillyAnne SchottZoe Vanella
NCIRobyn Burns (EMMES)Andrea DenicoffShanda FinniganSteve FriedmanLeeAnn JensenElise KreissJean LynnJoan MauerLori MinasianGary SmithCynthia Whitman
