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The legacy Cardinal.com Medical Ordering site has been replaced with Cardinal Health MarketSM, a new product experience designed with you in mind.
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Cardinal Health
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  • Anesthesia Supplies & Products
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  • Anesthesia Masks
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  • MYNX® Vascular Closure Devices
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  • Kangaroo™ Adult Nasogastric Feeding Tubes
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  • Kangaroo™ Irrigation Kits
  • Kangaroo™ Joey Enteral Feeding Pump and Sets
  • Kangaroo™ Neonatal & Pediatric Feeding System
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  • Resources
  • Cleanroom Gloves
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  • Urology
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  • GRIP™ Sealant
  • MYNX ACE® Vascular Closure Device
  • MYNXGRIP® Vascular Closure Device
  • A-V Impulse™ Controller
  • A-V Impulse™ Foot Compression System Tubing
  • A-V Impulse™ ImPad™ Rigid Sole Foot Covers
  • Sterile A-V Impulse™ ImPad™ Rigid Sole Foot Covers
  • Clinical evidence
  • Implementing VTE prevention best practices
  • Understanding the prevalence of VTE
  • Comfort Sleeves
  • Controller
  • Express Foot Cuffs
  • Express Sleeves
  • T.E.D.™ Anti-Embolism Stockings - Thigh Length
  • T.E.D.™ Anti-Embolism Stockings - Knee Length
  • Commodes and Accessories
  • Shower Chairs and Accessories
  • Toilet seats and Accessories
  • Exam Stools
  • Exam Tables
  • Halogen Light
  • Hamper Stands
  • IV Pole Products
  • Instrument Stands
  • Integrated Wall Systems
  • Kick Bucket
  • LED Light
  • Overbed Tables
  • Side Chairs
  • Step Stools
  • Utility Carts
  • Waste Cans
  • Canes and replacement parts
  • Crutches and Replacement Parts
  • Oxygen Tank Cart
  • Resources for Durable Medical Equipment
  • Rollators
  • Transport Chairs
  • Walkers
  • Wheelchairs and Accessories
  • Kangaroo™ Accessories with Safe Enteral Connections
  • Kangaroo™ CO₂ Detector for Gastric Tube Placement
  • Kangaroo™ Gastrostomy Feeding Tubes w/ Y-Port with Safe Enteral Connections
  • Kangaroo™ Safety P.E.G. Kits
  • Kangaroo™ Skin Level Balloon Gastrostomy Kits
  • Nasojejunal Feeding Tubes
  • Kangaroo™ Multifunctional Port
  • Nasogastric & Salem Sump™ Tubes
  • Salem Sump™ Tube with Anti-Reflux Valve
  • Kangaroo™ Feeding Tubes with Dobbhoff Tip
  • Kangaroo™ Feeding Tubes with Standard Tip
  • Kangaroo™ Non-Weighted Feeding Tubes
  • Kangaroo™ Gravity Sets and Extension Sets
  • Kangaroo™ Extension Set
  • Kangaroo™ Gravity Feeding System
  • Kangaroo™ Milk Straw
  • Kangaroo™ Polyurethane and Argyle™ PVC Feeding Tubes
  • Monoject™ Enteral Syringes and Syringe Accessories
  • Nutritional Delivery Product Catalog
  • ENFit® Connection System videos
  • Gastrointestinal Products
  • Kangaroo™ Connect Enteral Feeding Pump videos
  • Kangaroo™ Feeding Tube with IRIS Technology videos
  • Kangaroo™ Joey Enteral Feeding Pump videos
  • Kangaroo™ ePump Enteral Feeding Pump videos
  • Operating / user manuals
  • Pediatric NG tube placement videos
  • Non-sterile cleanroom gloves
  • Sterile cleanroom gloves
  • Clear Vinyl
  • High Use portfolio
  • Latex
  • Specialty portfolio
  • Stretch Vinyl with Neu-Thera®
  • Vinyl Stretch
  • Latex surgical gloves
  • Resources
  • Synthetic surgical gloves
  • 70% Isopropyl Alcohol Antiseptic
  • Chlorhexidine Gluconate
  • Hydrogen Peroxide
  • Sterilization Pouches, Tubing and Covers
  • Sterilization Wrap
  • Tray Liners
  • Disposable Bedding and Supplies
  • Disposable Gowns and Capes
  • Examination Table Paper
  • Eyewear and Face Shields
  • N95 Respirators
  • Qualitative Fit Test Kits
  • Resources
  • Surgical and Procedural Masks
  • Medi-Vac® Plastic Connectors
  • Medi-Vac® Suction Canisters
  • Medi-Vac® and Medi-Solid Plus™ Solidifiers
  • SAF-T Pump™ System
  • Absorbent Products 
  • Bone Marrow Biopsy/ Aspiration Needles
  • ChemoPlus™ Chemotherapy Training Kit
  • ChemoPlus™ Drug Transport Bags
  • Chemoplus™ Preparation and Administration Kits 
  • Chemoplus™ Vial Venting System 
  • IVA Seals and Labels
  • Other Protective Apparel
  • Spill Kits and Cleaning
  • Cardinal Health Paper Products
  • Chemotherapy Gowns
  • Coveralls
  • Footwear
  • Headwear
  • Isolation and Protective Gowns
  • Lab Coats and Jackets
  • Non-sterile Procedure Gowns
  • Resources
  • Scrubwear and Aprons
  • Surgical Clippers
  • Surgical Drapes
  • Surgical Gowns
  • 3-Spring Reservoirs
  • Jackson-Pratt® Channel Drains
  • Jackson-Pratt® Hemaduct® Drains
  • Jackson-Pratt® Perforated Drains
  • Penrose Drains
  • Cassettes and Accessories
  • Coverslippers
  • Coverslips, Cover Glass and Film
  • Cryostats
  • Cytology Supplies
  • Embedding Instruments
  • Embedding Materials
  • Grossing Accessories
  • Histology Reagents
  • Immunohistochemistry
  • Microscope Slides
  • Microtome Blades
  • Microtomes
  • Slide Stainers
  • Slide and Cassette Printers
  • Blood Bank Analyzers
  • Blood Bank Controls, Calibrators
  • Blood Bank Equipment
  • Blood Bank Reagents
  • Blood Bank Typing
  • Blood Gas Reagents and Accessories
  • Chemistry Reagents and Solutions
  • Clinical Chemistry Accessories
  • Clinical Chemistry Analyzers
  • Clinical Chemistry and Immunology Quality Controls
  • Immunology Reagents and Accessories
  • Molecular Reagents and Supplies
  • Special Chemistry Reagents and Stains
  • Special Chemistry Supplies
  • Toxicology Analyzers
  • Toxicology Reagents and Accessories
  • Cleaning Supplies
  • General Lab Chemicals
  • General Lab Supplies
  • Glucose Tolerance Beverages
  • Lab Labels and Tapes
  • Lab Liquid Handling
  • Lab Personal Protection
  • Lab Racks
  • Lab Temperature Monitoring
  • Lab Timers
  • Test Tube Closures
  • Test Tubes
  • Automated Coagulation
  • Hematology Automated Instruments
  • Hematology Slides, Consumables
  • Hematology Small Analyzers and Equipment
  • Hematology Stains
  • Urinalysis Automated Analyzers
  • Centrifuges
  • Cold Storage
  • Constant Temperature
  • General Lab Equipment
  • Lab Furniture
  • Lab Weighing
  • Safety Cabinets and Fume Hoods
  • Water Filtration System
  • Blood collection kits
  • Blood culture collection kits
  • Tissue biopsy kits
  • Urine collection kits
  • Microbiology Analyzers
  • Microbiology Collection and Transport
  • Microbiology Equipment
  • Microbiology Identification and Susceptibility
  • Microbiology Media
  • Microbiology Quality Controls
  • Microbiology Supplies
  • Nasopharyngeal and Oropharyngeal Swab Specimen Collection
  • ID NOW™
  • Lyra Influenza A+B Assay
  • Quidel Solana®
  • Resources for Quidel
  • POC Coag Analyzers, Access
  • POC Glucose Analyzers, Access
  • POC, Chemistry Analyzer, Access
  • Rapid Test Kits
  • Urinalysis Analyzer and Test Strips
  • Urinalysis Controls
  • Urinalysis system and components
  • Catalogs
  • Education
  • Government laboratories
  • Lab Week
  • Laboratory Excellence List
  • Blood Collection Tubes
  • Lab Lancets and Needles
  • Phlebotomy Supplies
  • Specimen Bags
  • Specimen Containers
  • Specimen Mailers and Shippers
  • Tourniquets
  • Electron Beam Cure Synthetic Polymers
  • Thermoreactively Cured Highly Purified Synthetic Hydrogels
  • Thermoreactively Cured Natural Polysaccharide Karaya
  • Ultraviolet Cured Polymers
  • Uni-Patch™ Accessories
  • Uni-Patch™ C Series Electrodes
  • Uni-Patch™ R Series Electrodes
  • Uni-Patch™ S Series Electrodes
  • Uni-Patch™ Skin Care
  • Uni-Patch™ Specialty Electrodes
  • Neonatal
  • Perineal Cold Packs
  • Ice Bags
  • Instant Cold Packs
  • Instant Hot Packs
  • Resources
  • Reusable Gel Packs
  • Uni-Patch™ Elastic Wrap
  • Uni-Patch™ Heavy Duty Cold Packs
  • Uni-Patch™ Reusable Hot/ Cold Gel Packs
  • Argyle™ Mucus Traps
  • Argyle™ Specimen Containers and Luki Tubes
  • Argyle™ Sterile Irrigating Solutions
  • Argyle™ Suction Catheter Kits and Mini-Trays
  • Argyle™ Suction Catheters
  • Argyle™ Tracheostomy Care Trays
  • Medical Needles and Syringes
  • Medication Preparation
  • Monoject™ Veterinary Supplies
  • Resources
  • Sharps Disposal
  • Waste Containers and Bags
  • Dover™ Closed System Drainage Bags and Meters
  • Dover™ Drainage Bags and Meters
  • External Catheters and Leg Bags
  • Intermittent Catheters and Trays
  • Irrigation Trays and Syringes
  • Latex Foley Catheters
  • Pediatric Products
  • Resources
  • Silicone and Silver Foley Catheters
  • Cables and Lead Wires
  • Cardiology Accessories
  • Defibrillator Pads & Electrodes
  • Diagnostic ECG Electrodes
  • Monitoring ECG Electrodes
  • Neonatal and Pediatric ECG Electrodes
  • Resources
  • Digital and Disposable Thermometers
  • Filac™ Electronic Thermometers and Accessories
  • Genius™ 3
  • Genius™ 3 Tympanic Thermometer
  • User Manuals & Resources
  • Disposable Blood Pressure Cuffs
  • Cardiology Chart Paper
  • Digital Imaging Media
  • Kendall™ Fetal Paper
  • Recording Chart Paper
  • Resources
  • Basic Stethoscope
  • Premium Stethoscopes
  • Single-Use Stethoscope
  • Vein Ablation Request Sample Kit
  • Alginate dressings
  • Composite dressings
  • Contact layers
  • Foam dressings
  • Hydrocolloids
  • Hydrogels
  • Transparent dressings
  • Wound solutions
  • Resources
  • How PHMB works
  • Underpads
  • Bladder Control Pads & Undergarment Guards
  • Children's Incontinence Products
  • Incontinence Briefs
  • Pad and Pant System
  • Pre-moistened washcloths
  • Protective Incontinence Underwear
  • Curity™ Alcohol Preps
  • Medicated Wipes
  • Webcol™ Alcohol Preps
  • Disposable NPWT Systems
  • Disposables and Accessories
  • Home Care
  • Resources
  • Reusable NPWT Systems
  • Simultaneous Irrigation™ Technology
  • All Day Moisturizer Cream
  • Antifungal Cream
  • Barrier Cream
  • Barrier Ointment
  • Bathing Wipes
  • Dry cloths
  • Manuka Honey Barrier Cream
  • No-Sting Barrier
  • Rinse-Free Foam Cleanser
  • Rinse-Free Perineal Cleanser
  • Rinse-Free Perineal and Skin Cleanser
  • Skin Care Basics
  • Skin Conditioner
  • Ancillary Medical Products
  • Bandage Rolls
  • Burn Care Dressings
  • Dressing Packs
  • Medical Tapes and Adhesives
  • Non-Adherent Dry Dressings
  • Non-Adherent Moist Gauze Dressings
  • Non-Woven Dressings
  • Wound Bandages
  • Woven Dressings
  • X-Ray Detectables
  • Chest Drainage
  • Perfusion Products
  • Procedural Trays
  • Thoracic Catheters
  • Devon™ Needle Counters
  • Devon™ OR Towels
  • Devon™ Surgical Markers
  • Kendall™ Solution Bowls
  • Lap Sponges
  • Light Handle Products
  • OR Essentials
  • Surgical Bowls and Medicine Cups
  • DEVON™ Foam Positioners
  • DEVON™ Positioning Kits
  • DEVON™ Positioning Straps
  • DEVON™ Supine Lithotomy Trendelenburg Kit
  • Economy Foam Positioners
  • KENDALL™ C-Section Strap
  • Reusable Gel Positioners
  • Devon™ Hands-Free Transfer Products
  • Devon™ Magnetic Drapes
  • Devon™ Magnetic Needle Finder
  • Devon™ Safety Strainer
  • Devon™ Sponge Counting System
  • Suction Instruments
  • Suction Tubing
  • Preoperative Skin Prep Components
  • LiquiBand® OCTYL Topical Skin Adhesive
  • LiquiBand® Butyl Topical Skin Adhesive
  • Resources
  • Argyle Umbilical Cord Clamp Clipper
  • Argyle™ Baby Board Straps
  • Argyle™ Infant Beanies
  • Cardinal Health™ ReliaMed® Lubricating Jelly
  • Cardinal Health™ Ultrasound Gels
  • Infant Footprinter Pads
  • Infant Tape Measure
  • Kendall™ Abdominal Belts
  • Kendall™ Abdominal Binder Rolls
  • Kendall™ Abdominal Binders with 2-way stretch
  • Kendall™ C-section Straps
  • Kendall™ Fetal Spiral Electrode System
  • Kendall™ Intrauterine Pressure Catheter System
  • Baby Care
  • Mom Care
  • Argyle™ Baby Hydrogel Adhesive Tape
  • Argyle™ Baby Phototherapy Eye Protectors
  • Argyle™ CPAP Nasal Cannula Kits
  • Argyle™ I.V Limb Support Boards
  • Argyle™ Neonatal-Pediatric Peripherally Inserted Central Catheters (PICCs) & Trays
  • Argyle™ Replogle Suction Catheters
  • Argyle™ Temperature Probe Covers
  • Argyle™ Umbilical Catheter Anchor
  • Argyle™ Umbilical Catheter Insertion Trays
  • Argyle™ Umbilical Vessel Catheters (UVCs)
  • Product videos
  • Biosimilar adoption low in RA
  • Improving biosimilar uptake in RA
  • Moving the needle on biosimilars
  • Survey: Biosimilars in rheumatology
  • Continuing Education
  • Nuctrac™
  • EDI 810 Invoicing
  • Nuclear Web Ordering
  • Reimbursement resources
  • Syntrac™ Integration Tools
  • PET
  • SPECT
  • Therapeutic
  • Health Physics Services
  • Accreditation and management
  • Bloodborne Pathogens standard
  • FDA-approved
  • Minimize radiation exposure
  • Needlestick safety
  • Other safety tools
  • PET biomarker manufacturing
  • Sealed sources
  • USP <797>
  • USP <825>
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  • Real-World Evidence: Why and How
medical professional with patient participating in study reviewing documents and smiling

Real-World Evidence: Why and How

Browse FOCUS Magazine 2018 edition

 

2018 edition

  • Letter from the editor
  • Real-World Evidence: Why and How
  • Real-World Trends in Disease Management
  • Use of RWE in Making Therapy Decisions

 

While randomized controlled trials represent the gold standard approach to change practice patterns and standards of care, patients enrolled in these studies do not represent the majority of patients seen in clinical practice. Patients seen in the real world are often older, of nonminority ethnic background, have comorbidities, and lack adequate psychosocial support. Furthermore, less than 5% of adult cancer patients in the United States are enrolled in clinical trials, meaning that almost 95% of cancer patients are treated in the real world. The 21st Century Cures Act attempts to address the need to understand outcomes of real-world treated patients through the incorporation of real-world evidence (RWE) into the drug-labeling process. It also suggests that observational studies are critical in the approval process, even for new indications. Much has been written in recent years about the advantages and challenges of RWE studies, and how best to utilize the data generated, moving forward.

To help us better understand the process and to shed some light on RWE studies, we caught up with Dr. Anthony Mato, Associate Attending and CLL Program Director at the Memorial Sloan Kettering Cancer Center in New York. The following are excerpts from my one-on-one conversation.

Chadi Nabhan: Why do you believe RWE studies are needed?

Anthony Mato: RWE studies are needed because there may be differences between patients who participate in clinical trials and those who are treated in clinical practice. These studies can help us to better understand the generalizability of clinical trial results to a community setting. In addition, these studies can help to answer questions that have not been addressed in current clinical trials, including expanded indications from label, toxicity profile, adherence, and unique head-to-head comparisons.

CN: How do you identify the best datasets to conduct RWE studies?

AM: The key to conducting RWE studies is to identify a dataset that accurately represents the patient population and has enough detail to answer the research questions of interest. These data can be available from administrative claims data, prospective registries, electronic health records, and retrospective cohort studies. Each of these approaches has clear advantages and disadvantages. Our approach has been to compile detailed patient-level data retrospectively from a network of academic and community sites with the main advantage of obtaining comprehensive data to answer key research questions in a timely manner.

CN: What are the advantages and disadvantages, or pitfalls, of conducting RWE studies?

AM: First, real-world studies should not be viewed as something that will replace a clinical trial. Real-world studies historically serve a different purpose, although that purpose is evolving with the passage of the 21st Century Cures Act. The major limitations of real-world studies is that they are often retrospective, some data may be missing, and patient-reported outcomes and toxicity data may not be able to be confirmed. Moreover, while it can be a strength, which I’ll get to, the fact that data are collected from many sites and the provision of care at those sites cannot be controlled like in a clinical trial, there is the potential for unmeasured confounding of the results, making it difficult to establish causation between a treatment and its effects.

Finally, inherent to the retrospective nature, the follow-up on patients may be variable both in time and place. You can’t be sure that the events of interest will have occurred, and patients may be followed at disparate intervals depending upon the provider as opposed to a clinical trial where follow-up is prespecified.

That being said, what is the place and advantage of real-world research? Traditionally, from the manufacturer perspective they have been used to build evidence for payers and to collect data for supporting formulary decision making from a cost perspective. Real-world data has been viewed by clinicians with a skeptical eye owing the inherent biases due to their nonrandom, retrospective design (in most cases). In addition, the datasets used traditionally have lacked deep clinical detail for the estimation of outcomes beyond items such as costs of care. With the advent of EMR technology we all realized that there is data which is collected through routine clinical practices that can fill some, but not all of these gaps. With the limitations of these data their strengths lay in several areas.

First, conducting real-world research is typically less expensive and time consuming. Whether using existing data or collecting primary data because care is delivered in the routine setting without an intervention, there is less risk to the patient, oversight by regulators, and the need for detailed assessments performed at specified intervals.

Second, providers will choose the treatment for a patient which is the best fit for that patient. In that case, real-world data is much more powerful in understanding the outcomes of patients in diverse settings and in populations of patients not evaluated in the clinical trial. This also allows you to study questions not answered in clinical trials potentially to inform future trial design.

Finally, clinical trials are often conducted in academic settings where the type of care delivered is differently than that given in a community practice. As a result, real-world evidence can shed light on how the process of care delivery in the real world affects outcomes for patients.

CN: Why do you believe there is an increased emphasis on RWE now versus several years ago?

AM: The field of oncology has changed dramatically in recent years with many new agents coming to the markets which have changed the treatment paradigm. In CLL, four oral targeted therapies were approved and brought to market in 2014; several more approvals are likely to occur in the next 1-2 years. With this, clinical trials have been insufficient to address all the needed questions to inform clinical practice. In particular, clinical trials have been unable to address questions related to sequencing of these agents. RWE studies may also help to refine the toxicity profile of approved agents. For example, in CLL, we identified pneumonitis as a unique unreported toxicity of the BTK inhibitor, ibrutinib, in our retrospective RWE cohort studies.

CN: Tell us about CORE and how it started.

AM: In collaboration with you, the Cardinal Health team, and other investigators across the United States, we have developed a grassroots network of centers that have committed to sharing data to answer key questions in CLL. This has led to several presentations at national meetings and publications in high-impact journals that have helped to shape the field and inform clinical practice. We have partnered with AbbVie to expand upon this ongoing effort and have called this study the CORE Study (CLL Collaborative Study Of Real-World Evidence). I believe that similar efforts could be done for other disease states and this is just one example on how we are attempting to answer RWE questions in the field of CLL.

CN: Any suggestions on how to engage community oncologists in RWE studies?

AM: RWE datasets should be presented at meetings that are frequently attended by community oncologists and presented in journals that have a high-impact value to clinicians. In addition, large community research networks such as US Oncology and Sarah Cannon could be engaged to contribute to RWE studies. The work presented by Cardinal Health at the 59th ASH Annual Meeting & Exposition is an example of how a GPO can utilize its community network to effectively engage community sites in RWE research.

CN: What does the future look like for RWE studies?

AM: As we get more advanced in establishing and utilizing systems to collect real-world data, we will have more robust information to expand its applications and address its perceived limitations. These data have and will continue to have increasing roles with regulatory bodies, payers, pathway companies, and guideline organizations to inform key decisions.

Chadi Nabhan, MD, MBA, FACP Chief Medical Officer, Cardinal Health Specialty Solutions

Chadi Nabhan, MD, MBA, FACP

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