[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77833-77834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on CYP2C19 Variants and Platelet
Reactivity Tests
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Scientific Information Submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from manufacturers of
CYP2C19 variants and platelet reactivity tests. Scientific information
is being solicited to inform our Comparative Effectiveness Review of
Testing of CYP2C19 Variants and Platelet Reactivity for Guiding
Antiplatelet Treatment, which is currently being conducted by the
Evidence-based Practice Centers for the AHRQ Effective Health Care
Program. Access to published and unpublished pertinent scientific
information on this device will improve the quality of this comparative
effectiveness review. AHRQ is requesting this scientific information
and conducting this comparative effectiveness review pursuant to
Section 1013 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173.
DATES: Submission Deadline on or before January 13, 2012.
ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the
study for which you are submitting information from the list of current
studies and complete the form to upload your documents.
Email submissions: ehcsrc@ohsu.edu (please do not send zipped
files--they are automatically deleted for security reasons).
Print submissions: Robin Paynter, Oregon Health and Science
University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson
Park Road, Mail Code: BICC, Portland, OR 97239-3098.
FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian,
Telephone: (503) 494-0147 or Email: ehcsrcohsu.edu.
SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003,
Public Law 108-173, the Agency for Healthcare Research and Quality has
commissioned the Effective Health Care (EHC) Program Evidence-based
Practice Centers to complete a comparative effectiveness review of the
evidence for testing of CYP2C19 variants and platelet reactivity for
guiding antiplatelet treatment.
The EHC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by systematically requesting
information (e.g., details of studies conducted) from medical device
industry stakeholders through public information requests, including
via the Federal Register and direct postal and/or online solicitations.
We are looking for studies that report on CYP2C19 variants and platelet
reactivity tests, including those that describe adverse events, as
specified in the key questions detailed below. The entire research
protocol, including the key questions, is also available online at:
http://effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=854#3962.
This notice is a request for industry stakeholders to submit the
following:
A current product label, if applicable (preferably an
electronic PDF file).
Information identifying published randomized controlled
trials and observational studies relevant to the clinical outcomes.
Please provide both a list of citations and reprints if possible.
Information identifying unpublished randomized controlled
trials and observational studies relevant to the clinical outcomes. If
possible, please provide a summary that includes the following
elements: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to withdrawn/follow-
up/analyzed, and effectiveness/efficacy and safety results.
Registered ClinicalTrials.gov studies. Please provide a
list including the ClinicalTrials.gov identifier, condition, and
intervention.
Your contribution is very beneficial to this program. AHRQ is not
requesting and will not consider marketing material, health economics
information, or information on other indications. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
In addition to your scientific information please submit an index
document outlining the relevant information in each file along with a
statement regarding whether or not the submission comprises all of the
complete information available.
Please Note: The contents of all submissions, regardless of
format, will be available to the public upon request unless
prohibited by law.The draft of this review will be posted on AHRQ's
EHC program Web site and available for public comment for a period
of 4 weeks. If you would like to be notified when the draft is
posted, please sign up for the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
The Key Questions
Key Question 1
In patient populations who are candidates for clopidogrel therapy,
does
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genetic testing for CYP2C19 variants predict intermediate and clinical
outcomes following treatment initiation?
a. What is the analytic validity (technical test performance) of
the various assays used for CYP2C19 genetic testing?
b. What is the clinical validity (predictive accuracy) of genetic
testing for predicting intermediate and clinical outcomes in patients
who are receiving clopidogrel therapy?
c. Do the following factors modify the association between genetic
test results and clinical outcomes?
i. Co-medications.
ii. Patient-level factors (e.g., race or ethnicity, age, sex,
disease severity, or comorbidities).
iii. Test-related factors (e.g., between-assay differences).
iv. System-level factors (e.g., settings where testing is
performed).
Key Question 2
In patient populations receiving clopidogrel therapy, does
phenotypic testing of platelet reactivity predict intermediate and
clinical outcomes?
a. What is the analytic validity (technical test performance) of
the various assays used in phenotypic testing of platelet reactivity?
b. What is the clinical validity (predictive accuracy) of
phenotypic testing for predicting intermediate and clinical outcomes in
patients who are receiving clopidogrel therapy?
c. Do the following factors modify the association between
phenotypic test results and clinical outcomes?
i. Co-medications.
ii. Patient-level factors (e.g., race or ethnicity, age, sex,
disease severity, or comorbidities).
iii. Test-related factors (e.g., between-assay differences).
iv. System-level factors (e.g., settings where testing is
performed).
Key Question 3
What is the comparative effectiveness of alternative test-and-treat
strategies (including a no-testing strategy) for therapeutic decision
making regarding antiplatelet therapy among patients who are candidates
for clopidogrel-based treatment?
a. What is the comparative effectiveness of the following testing
strategies on therapeutic decision making, platelet reactivity during
followup, and clinical outcomes in patients who are candidates for
antiplatelet treatment?
i. Genetic testing for CYP2C19.
ii. Genetic testing for CYP2C19 followed by phenotypic testing for
platelet reactivity.
iii. Phenotypic testing for platelet reactivity.
iv. No testing.
b. How do modifying factors (e.g., race or ethnicity, age, sex,
comorbidities, diet, or the time between conducting the test and
obtaining results) affect the association of alternative phenotypic or
genetic test-and-treat strategies and patient outcomes? Alternative
test-guided treatments can include non-clopidogrel antiplatelet agents
or high-dose clopidogrel regimens.
Key Question 4
What are the potential adverse effects or harms from genetic or
phenotypic testing per se or from test-directed treatments?
Dated: December 2, 2011.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2011-32047 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-90-M