VSD.SampleTaskOrder 4.doc

Attachment F

SAMPLE TASK ORDER # 4

TITLE OF PROJECT: Monitoring the safety of quadrivalent human papillomavirus vaccine among males in near real time

1. APPLICABILITY

This effort is within the scope of the basic contract discussed in 5.2 of the basic PWS

2. ORDER TYPE

The effort shall be proposed on a Cost-Plus-Fixed-Fee basis.

3. PERIOD OF PERFORMANCE

The period of performance is from the date of the contract award for twelve months.

4. PLACE OF PERFOMANCE

Services will be performed at vendor specified site in the United States.

5. BACKGROUND AND NEED

In October 2009, the Food and Drug Administration approved quadrivalent human papillomavirus vaccine (HPV4) for use in males 9-26 years. The Advisory Committee on Immunization Practices (ACIP) issued a permissive recommendation for HPV4 use in males aged 9-26 years in October 2009 and recommended routine use in males age 11-21 years in October 2011. While the Vaccine Adverse Event Reporting System (VAERS) has monitored adverse events following HPV4 among males since the vaccine has been licensed, no active surveillance has been conducted. With the new ACIP recommendation for routine use of HPV4 among males, we expect that uptake of this vaccine is going to increase. Near-real time monitoring of adverse events following HPV4 among males is needed.

6. PROJECT OBJECTIVE

The purpose of this task order is for a contractor to develop a protocol, coordinate and lead activities in order to identify and investigate possible associations between receipt of HPV4 and a pre-specified list of adverse events through near-real time monitoring.

7. SCOPE OF WORK

This task order is for a contractor to develop a scientifically sound surveillance protocol for the near real-time monitoring of adverse events following HPV4. In addition the contractor will serve as a lead to coordinate surveillance activities among participating sites for signal detection and signal refinement.

8. TECHNICAL REQUIREMENTS

A. The contractor shall write a draft surveillance protocol to assess the association between a specified list of adverse events and receipt of HPV4 vaccine among males in near real time.

B. The contractor shall determine the pre-specified list of potential adverse events (outcomes) that will be monitored over the surveillance period. Relevant ICD-9 codes and definitions for each outcome will be developed and included in the protocol, as well as comparison groups, observation window under surveillance after vaccination, medical setting, and any other information needed.

C. The contractor will be responsible for developing an analytic plan including defining exposed and comparison groups as well as type of sequential design to be employed.

D. Data for conducting this surveillance project will utilize the VSD dynamic data files and follow the VSD data dictionary.

E. For those outcomes in which medical record review has been decided a priori to be conducted, the contractor will create chart abstraction instruments.

F. The contractor shall include a plan for initial assessment of potential signals (e.g., evaluation of temporal trends, heterogeneity by sites, data quality issues (including a limited chart review of less than 40 charts), and alternative analytical methods). A separate task order will be issued for any signal follow-up requiring more detailed data collection (e.g., extensive medical chart review).

G. The contractor will participate on regular conference calls with the Government and the VSD project to discuss the draft surveillance plan protocol, estimated uptake of vaccine, and results of sequential analyses. The contractor will seek approval of the protocol by the Government.

H. The contractor shall be responsible for seeking IRB approval as well as coordinating approvals by participating sites (if needed).

I. The contractor shall be responsible executing data use agreements between participating sites, if needed, J. The contractor will create SAS programs to extract analytic data and implement surveillance design. If a historical comparison is used, the contractor will generate background rates.

K. Through the DDM, CDC will run a SAS program created by the contractor on a weekly basis to collect the necessary IRB approved data files. The contractor shall run analyses on a routine basis in order to monitor counts and rates for signal detection. The frequency of analyses will be determined by the methods chosen.

L. The contractor shall generate monitoring reports at the time of each statistical test and disseminate reports to CDC.

M. The contractor shall present findings of surveillance if requested to the Advisory Committee on Scientific Practices and other advisory bodies as requested.

N. The contractor shall draft a manuscript describing surveillance project and results. The surveillance protocol shall specify an “end of surveillance” plan for the final analysis to be included in the manuscript.

9. DELIVERABLES

E= Electronic copy only

Contractors shall propose a delivery schedule and any additional deliverables that will enhance the contractor’s ability to manage and successfully complete the work and/or facilitate oversight by the COTR and VSD Project staff.

10. SPECIFIC TASK ORDER INSTRUCTIONS

Methodology and technical approach: The Contractor should provide a narrative describing their technical understanding of the work.

A. Describe the Contractor’s understanding of near-real time surveillance B. Describe Contractor’s understanding of potential safety issues associated with HPV vaccination of males and challenges to monitoring for possible safety signals C. Describe the Contractor’s proposed approach to leading a near-real time surveillance project including:

1. Describe the approach the contractor will undertake to write the protocol including selecting outcomes of interest and associated ICD9 codes, choice of designs (historical, concurrent comparison group, self-control, etc.), determining risk windows, and statistical testing methods

2. Describe the Contractor’s ability to utilize SAS to write an extraction program in order to obtain the analytical files needed for monitoring.

3. Describe the Contractor’s approach for expeditious IRB approval and DUA execution for surveillance, including modifications to the protocol

4. Describe the Contractor’s ability to conduct statistical sequential methodologies when conducting near real time surveillance

5. Describe approach to conducting an initial assessment of any potential signals that may be identified