Oversight and Monitoring in trials of tests:
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1 Oversight and Monitoring in trials of tests: Remits, roles and working models Jon Deeks Lavinia Ferrante di Ruffano, Jane Daniels, Jac Dinnes, Nicholas Hicks, Richard Kaplan, Richard Riley
2 Project rationale Clinical trials independent monitoring required (NIHR, MRC) Treatment trials two independent committees: Trial Steering Committee Data Monitoring and Ethics Committee Trials of tests: awareness of variation in approach committees do not always have no existing guidelines/recommendations
3 Definitions... Trial Steering Committee» Overall supervision to ensure GCP & protect funder or sponsor» At least part independent» Monitors study progress, protocol adherence, patient safety, new external information Data Monitoring Committee» Ensuring the ethical continuation of a study» Review emerging findings (unblinded data)» Monitors safety & outcome data to recommend continuation, modification or termination
4 How should TSCs and DMCs operate in prospective evaluations of medical tests? Project methods: Review of existing guidance» Policies/guidance from key organisations Web based survey:» Prospective evaluations of tests HTA & ANZCTR» TSC/DMC models used» Roles & responsibilities of committees
5 How should TSCs and DMCs operate in prospective evaluations of medical tests? Project methods: Case studies:» Survey respondents» Classification of study designs, study risks and use of TSC/DMC structures Proposal:» Guidance for when to use TSCs and/or DMCs in test evaluation Consensus meeting:» Recommendations,?charter
6 Identification of studies Inclusion criteria:» Evaluation of any medical test (all study designs)» Completed since January 2010 NIHR Health Technology Assessment Programme (HTA)» ongoing and published primary test evaluation studies» 64 trials invited to participate in survey Australia & New Zealand Clinical Trials Register (ANZCTR)» Diagnosis Or Screening 411 trials invited» Irrelevant studies excluded from responses
7 Online survey response 21 HTA funded primary test evaluations 33% response rate (n=64) 5 studies registered on ANZCTR 1% response rate (n=411) 10 RCTs (any outcome) 12 Accuracy studies (non RCT design) 4 Predictive value studies (non RCT design)
8 TSC/DMC models used TSC and DMC, wholly separate TSC with subgroup DMC TSC with joint role of DMC TSC only DMC only Neither TSC nor DMC
9 TSC/DMC models used TSC and DMC, wholly separate 9 (7 RCTs, 2 Accuracy) TSC with subgroup DMC TSC with joint role of DMC TSC only DMC only Neither TSC nor DMC 2 (Accuracy) 1 (Accuracy) 7 (4 Accuracy, 3 Prediction) 3 (RCT, Accuracy, Prediction) 4 (2 RCTs, 2 Accuracy)
10 Structure of oversight and monitoring in test evaluation: 3 EXAMPLES
11 1. PET CT for diagnosis and staging pancreatic cancer Suspected pancreatic malignancy MDCT + other routine tests (US/histology/biopsy/laparoscopy) Pre test: diagnosis, stage, management plan decided» TSC (part independent)» DMC (fully independent)» wholly separate PET CT Post test: diagnosis, stage, management plan reviewed with PET CT results Independent panel diagnosis (histology/12mth clinical outcome) Accuracy & Diagnostic Impact of PET CT
12 2. New imaging tests for Glaucoma Referred with possible glaucoma» TSC (part independent)» No DMC Confocal laser scan Scanning laser polarimetry Optical coherence tomography Consultant clinical assessment (pressure test, optic nerve exam, visual field testing) Accuracy
13 3. Bladder US for diagnosis of detrusor overactivity Symptoms of urinary frequency, urgency, urge incontinence Bladder Ultrasound» TSC (part independent)» DMC subgroup of TSC (all independent TSC members bar the chair) Urodynamics assessment (uroflowmetry, pressure flow studies) Accuracy
14 Study risks» Adverse events from index test(s)» Adverse events from reference test(s)» Impact of testing on patient care» Practice changing results (early stopping)» Parameter estimate checking» Quality assurance of test procedures» Assurance of scientific validity
15 1. PET CT for diagnosis and staging pancreatic cancer Suspected pancreatic malignancy MDCT + other routine tests (US/histology/biopsy/laparoscopy) PET CT Independent panel diagnosis (histology/12mth clinical outcome) Accuracy & Diagnostic Impact of PET CT» TSC (part independent)» DMC (fully independent)» wholly separate Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
16 1. PET CT for diagnosis and staging pancreatic cancer Suspected pancreatic malignancy MDCT + other routine tests (US/histology/biopsy/laparoscopy) PET CT Independent panel diagnosis (histology/12mth clinical outcome) Accuracy & Diagnostic Impact of PET CT» TSC (part independent)» DMC (fully independent)» wholly separate Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
17 2. New imaging tests for Glaucoma Referred with possible glaucoma» TSC (part independent)» No DMC Confocal laser scan Scanning laser polarimetry Optical coherence tomography Consultant clinical assessment (pressure test, optic nerve exam, visual field testing) Accuracy Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
18 2. New imaging tests for Glaucoma Referred with possible glaucoma» TSC (part independent)» No DMC Confocal laser scan Scanning laser polarimetry Optical coherence tomography Consultant clinical assessment (pressure test, optic nerve exam, visual field testing) Accuracy Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
19 3. Bladder US for diagnosis of detrusor overactivity Symptoms of urinary frequency, urgency, urge incontinence Bladder Ultrasound Urodynamics assessment (uroflowmetry, pressure flow studies) Accuracy» TSC (part independent)» DMC subgroup of TSC (all independent TSC members bar the chair) Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
20 3. Bladder US for diagnosis of detrusor overactivity Symptoms of urinary frequency, urgency, urge incontinence Bladder Ultrasound Urodynamics assessment (uroflowmetry, pressure flow studies) Accuracy» TSC (part independent)» DMC subgroup of TSC (all independent TSC members bar the chair) Study Risks» Adverse events index test(s)» Adverse events reference test(s)» Impact of testing on patient care» Practice changing results» Parameter estimate checking» QA of test procedures» Assurance of scientific validity
21 Other influential factors Need for independent monitoring committee» Protection against conflict of interest» Review study progress in context of other research» Clinician knowledge of all test results Ability to alter study progress or protocol» Delayed reference standard» Short study duration
22 Project deliverables Consultation document Roles and responsibilities of TSCs and DMCs Checklist to inform TSC/DMC model» Categorisation of study risks
23 Table of pros and cons for each model type Resource saving Indep. review study progress Reveiw blind study data Protect against conflict of interest Protect patient interests Protect funder interests Indep. review of study in context new research TSC and DMC, wholly separate TSC with subgroup DMC? TSC with joint role of DMC??? TSC only? DMC only Neither TSC nor DMC
24 What you can do for us Examples of primary test evaluations Different oversight/monitoring models Comment on our consultation document Other influential factors
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