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Clinovo1208 E. Arques Avenue, Suite 114Sunnyvale, CA [email protected]+1 800 987 6007 www.clinovo.com
CONDUCTING POST MARKET REGISTRIES
RATIONALE AND EXECUTIONPRESENTATION FOR THE ACRP 2015 GLOBAL CONFERENCE & EXHIBITION
Written by Ale Gicqueau, President and Founder at Clinovo
2© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Post market registries can provide valuable real-life data for publication,
reimbursement and improve the medical device and indication expansion.
Creating these registries require careful planning and coordination.
Clinical data is essential in providing clinical evidence for medical
products, and to better understand the device safety and efficacy after
clearance or approval. Clinical trials are becoming cost prohibitive as trials
require to follow Good Clinical Practice, to be closely monitored to ensure
data quality and to adhere to inclusion and exclusion criteria.
Clinical registries provide a real-life exposure to the use of the device, and
can provide valuable clinical data, if designed appropriately at a fraction
of the price of industry-sponsored clinical trials.
Abstract
3© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Registry Studies
Observational · Look backwards without dictating a treatment planObserve what was done
Not viewed as second-rate clinical trials
Clinical Trials
Investigational · Look forward to what shall be done
Dictate and control a treatment plan
Shows investigators how to do it
Registry Studies vs Clinical Trials
4© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Define the hypotheses related to safety, efficacy, and cost
Define endpoints or outcomes that will support or refute the
hypotheses
Inclusion and exclusion criteria for who will be in the study
Design of Registries
5© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Data Collection
Patient Demographics
Medical History
Health Status
Patient’s Experience with Technology or Device
Primary and Secondary Endpoints
Adverse Events
Technology Deficiencies
6© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
IRB approval
HIPAA waiver to access patient’s medical records
Financial Agreement with institution regarding payments, and
data ownership
Assurances of patient privacy
Ethics, Data Ownership, and Privacy
7© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Sites
Pay fair-market value for their time
Endorsed by leading organizations, and respected
opinion-leader
Provide useful self-assessment data to physician
Patients
Recruitment by patient’s own physician
Provide written materials in language easily understood by
public
Keep survey forms short and simple
Provide incentives
Recruitment
8© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Case Report Forms
Forms where data is gathered, entered into coded database, and
stored in a clinical database
Data Dictionary
Detailed description of each variable used in
the registry
Data Collection and Quality Assurance
9© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Monitoring
Verify that the subject exists
Verify that the subject has disease or condition under study
Subject met inclusion and exclusion criteria
Signed and informed consent and HIPAA authorization
Received or declined treatment
10© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Analysis and Interpretation
Determine how closely the study population represents the
population
Statistical analysis plan for how the data are to be analyzed and
interpreted with regard to accepting or refuting the hypothesis
Plan for how to handle missing data
11© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Conclusion
Registry Studies are a great mean for large clinical data collection
They appear as a great tool for market expansion
Choosing the appropriate database that tailors your needs and
capabilities is key
Many solutions such as ClinCapture are available today and can
provide a scalable and cost effective solutions
12© 2015 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Contact
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