Implementation of Electronic Capture of PROs in NCI Clinical Trials. Lori Minasian, MD, FACP Deputy Director, Division of Cancer Prevention, NCI
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1 Implementation of Electronic Capture of ROs in NCI Clinical Trials Lori Minasian, MD, FAC Deputy Director, Division of Cancer revention, NCI May 11, 2017
2 Objectives 1. rovide framework for the collection of atient Reported Outcomes (ROs) in NCI clinical trials. 2. rovide update on the implementation of the electronic capture of ROs in NCI clinical trial networks. 2
3 RO QOL HRQOL Evaluation of all aspects of life QOL Health-Related Quality of Life atient Reported Outcomes Quality of Life HRQOL ROs Anything reported by the patient Evaluation of impact of illness or treatment on physical, emotional, & social aspects of QOL
4 Vision for ROs in NCI Clinical Trials Incorporate patient reported outcomes into the study design to identify safe and effective interventions to treat, prevent and control cancer. Evaluating impact of treatment and disease on HRQOL atient reporting of symptomatic adverse events Consistent with FDA atient Centered Drug Development Improve operational efficiency through the electronic collection of ROs for investigators, site staff, and patients treamline data collection and analysis with integration of ROs into the existing electronic data collection Improve feasibility and usability to enhance patient participation in RO collection 4
5 Why include RO data? RO questions can provide additional information to assess the overall risk/benefit Are the symptoms of disease improving? Is the functionality changing to benefit patient? Are the side effects too bothersome? Are the side effects exacerbated because of co-morbidities? Is there a difference in Health Related Quality of Life based upon the treatment intervention? Not All tudies Need to Include ROs
6 What information needs to be in the protocol document? RO hypothesis should be included in the study objectives Why are you collecting ROs? How will they inform the other study endpoints? Data collected reflects the clinical issue. Time points for collection correspond to the rationale for inclusion of the RO instruments tatistical methods are stated in the protocol, Data analysis and include sample size
7 RO-CTCAE 7
8 RO-CTCAE Item Library of 78 AE items Derived from CTCAE atients asked to score attributes (presence, severity, frequency, and interference) independently ublicly released on April 2016 ( Not every item is intended for use in one trial Designed to systematically capture symptomatic AEs from patients and complement clinician rated CTCAE elected relevant RO-CTCAE items are chosen For prospective assessment Not currently for protocol specific action 8
9 imilar Data, Different urposes CTCAE Clinician reported afety signal Medical evaluation Each AE is graded 1-4 Grade prompt dosing decisions Grades 3-5 reported descriptively, Tables do not account for trajectory of toxicity RO-CTCAE atient reported Tolerability signal Each item may have 3 separate scores (frequency, severity, interference) cores do not prompt dosing decisions tandard approach to reporting and analyzing scores not established 9
10 ATIENT-REORTED OUTCOME VERION OF THE COMMON TERMINOLOGY CRITERIA FOR ADVERE EVENT (RO-CTCAE ) ITEM LIBRARY (Version 1.0) Gastrointestinal Taste changes Decreased appetite Nausea Vomiting Heartburn Gas Bloating Hiccups Constipation Diarrhea Oral Dry mouth Difficulty swallowing Mouth/throat sores Cracking at the corners of the mouth (cheilosis/cheilitis) Voice quality changes Hoarseness Abdominal pain Fecal incontinence I I F F F F F F FI FI Cardio/Circulatory welling Heart palpitations Cutaneous Rash kin dryness Acne Hair loss Itching Hives Hand-foot syndrome Nail loss Nail ridging Nail discoloration ensitivity to sunlight Bed/pressure sores Radiation skin reaction kin darkening tretch marks FI F Neurological Numbness & tingling Dizziness Visual/erceptual Blurred vision Flashing lights Visual floaters Watery eyes Ringing in ears Attention/Memory Concentration Memory ain General pain Headache Muscle pain Joint pain I I I I I I FI FI FI FI leep/wake Insomnia Fatigue Anxious Mood Discouraged ad I I Gynecologic/Urinary Irregular periods/vaginal bleeding Missed expected menstrual period Vaginal discharge Vaginal dryness ainful urination Urinary urgency Urinary frequency Change in usual urine color Urinary incontinence FI FI FI FI I FI exual Achieve and maintain erection Ejaculation Decreased libido Delayed orgasm Unable to have orgasm ain w/sexual intercourse Miscellaneous Breast swelling and tenderness Bruising Chills Increased sweating Decreased sweating Hot flashes Nosebleed ain and swelling at injection site Body odor F F F F F Respiratory hortness of breath Cough Wheezing I I Dimensions F: Frequency I: Interference : everity : resence/absence /Amount
11 Collection Methods for ROs aper and pencil Long history of paper booklet collection Telephone ome Groups have central telephone collections IVR useful Electronic Industry using electronic direct patient capture methods Increasingly being used, often with device provided by study RTOG has used VisionTree for electronic data collection (a few trials) ACRIN has used EAEERO for ero collection for COMET Alliance has begun work with Medidata ero Flexibility for Multiple Modalities is key 11
12 atient Cloud ero Overview What is atient Cloud ero? A mobile app that collects patient responses to questionnaires / diaries and transfers data to the Medidata Clinical Cloud elf-service setup and execution via intuitive role-based user interface Fully integrated with Rave EDC to leverage the entire Medidata platform Available for Android and io mobile devices 12
13 atient Cloud ero Overview List of Instruments atient Questionnaire RO-CTCAE 13
14 ero Implementation roject tart with pilot Collaborative process with the Groups rotocol developers, data managers Understand logistical and workflow issues for ROs and unique aspects for electronic collection Currently we have identified 13 clinical trials for inclusion Anticipate trials for NCTN and NCOR Any RO tool that has verified for electronic platform Anticipate 4-5 trials for ETCTN Generate data from the use of RO-CTCAE in clinical trials for the next step of its development Both in early and late phase trials 14
15 How are ROs Funded in NCI Clinical Trials Networks? ROs captured in Cancer revention and Control Trials Division of Cancer revention funded NCOR Grant ROs may be the primary endpoint for cancer control trials Cancer Control Credits ROs captured in Cancer Treatment Trials Division of Cancer Treatment and Diagnosis funds the NCTN Grant Cancer Control Credits for hypothesis driven ROs Cancer Control Credits from DC NCOR Grant All Endpoints in Cancer Trials undergo scientific review Biospecimen collection need prospective analytic plan ROs also must have a prospective analytic plan One exception is RO-CTCAE 15
16 Who works with ROs in the Alliance? Health Outcomes Committee Home for developing RO questions for inclusion with trials Reviews Correlative tudies which include HRQOL and ROs ymptom Management Committee Design studies that may have RO primary endpoints Disease Committees Consider the inclusion of ROs into disease specific protocols atient Advocates erspective for information to be collected and patient burden erspective on feasibility of capturing different kinds of information Alliance ero pilot study 16
17 ummary NCI is committed to including the patient voice through the inclusion of ROs in clinical trials Multiple different ROs instruments are used across the NCI clinical trials networks HRQOL, RO-CTCAE, others Need hypothesis and analytic plan for inclusion All ROs undergo scientific review Electronic collection of ROs is being implemented in a way consistent with other electronic clinical trial data RO-CTCAE is a newly developed instrument ystematic capture of patient reported symptomatic adverse events (still under construction) 17
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PRO-CTCAE PATIENT-REPORTED SYMPTOMATIC ADVERSE EVENTS. Lori Minasian, MD, FACP Deputy Director, Division of Cancer Prevention, NCI
1 RO-CTCAE ATIENT-REORTED YMTOMATIC ADVERE EVENT Lori Minasian, MD, FAC Deputy Director, Division of Cancer revention, NCI 2 Disclosures I work for the UA Federal Government I have no financial conflicts
PRO-CTCAE : PATIENT-REPORTED OUTCOMES VERSION OF CTCAE. Lori Minasian, MD Deputy Director, Division of Cancer Prevention, NCI
1 RO-CTCAE : ATIENT-REORTED OUTCOME VERION OF CTCAE Lori Minasian, MD Deputy Director, Division of Cancer revention, NCI 2 Disclosures I work for the UA Federal Government I have no financial conflicts
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