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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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A Post-Marketing Real World Study


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General
Study Status Study Pending
Application Number P130017 S029/ PAS001
Date Current Protocol Accepted 08/26/2020
Study Name A Post-Marketing Real World Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective is to evaluate the performance of Cologuard for CRC screening in patients under the age of 50 by collecting real world data on subsequent CRC screening and CRC-related outcomes.



This post-approval observational study is a largely automated multi-center study that will collect data from Integrated Delivery Networks (IDNs), hospital systems, and large primary care practices to generate a longitudinal record of patients’ journeys prior to and following an initial Cologuard screening. This approach relies on technology-based data collection to eliminate the need for ongoing manual data collection, abstraction, entry, and cleaning at the site level and ensures that all eligible patients are enrolled.



The study will leverage digitized data from structured and unstructured fields (e.g., pathology reports) from multiple sources and systems [e.g., EMR, ambulatory procedure centers (for colonoscopies), laboratory data, pathology information].



It is anticipated that at least 50,000 eligible patients under the age of 50 at the time of routine screening with Cologuard will be included in the study. Both Cologuard-positive and Cologuard-negative patients will be followed for subsequent CRC assessments and CRC-related outcomes.



Study Population Description All patients under the age of 50 undergoing CRC screening with a completed Cologuard test as part of routine clinical monitoring at each site, regardless of risk status, will be eligible for inclusion. Patients considered off-label, such as those meeting high-risk criteria and/or less than 45 years of age at the time of screening will be included and analyzed separately. Patients with orders for Cologuard but no recorded results will be excluded.



Data from the EMR will be used to determine risk status after the patient is included in the study. Patients will be considered high risk based on the presence of any of the following:



History of CRC, advanced adenoma, or other related cancer

Inflammatory bowel disease (IBD)

Chronic ulcerative colitis (CUC)

Crohn’s disease

Familial adenomatous polyposis (FAP)

Relevant familial hereditary cancer syndromes

Family history of CRC
Sample Size At least 50,000 patients will be included, which is anticipated to yield 12 CRC cases. If by chance no CRC cases are identified in the first 50,000 enrollees, the study will continue to accrue patients until at least one CRC case is identified in the patient population. Based on preliminary studies, a positive Cologuard rate of approximately 7% (n=~3500) is expected.
Data Collection The following outomes will be evaluated:

Cologuard positivity rate

Compliance to diagnostic colonoscopy within 12 months

CRC detected on colonoscopy following a positive Cologuard result

Advanced adenomas on colonoscopy following a positive Cologuard result

Non-advanced findings or no findings on colonoscopy following a positive Cologuard result

Observed specificity

CRC-related diagnoses within 36 months of a negative Cologuard result

Observed sensitivity

Follow-up Visits and Length of Follow-up Total study duration is estimated at 72 months, depending on the rate of uptake of Cologuard in the target population. For patients with a positive Cologuard result, at least 12 months of follow-up after the patient index date (initial Cologuard screening date) will be evaluated for colonoscopy results. For patients with a negative Cologuard result, at least 36 months of follow-up after the index date will be evaluated to ensure capture of potential positive CRC cases.


A Post-Marketing Real World Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/20/2020 03/18/2020 On Time
one year report 09/19/2020    
18 month report 03/20/2021    
two year report 09/19/2021    
three year report 09/19/2022    
four year report 09/19/2023    
five year report 09/18/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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