CLINICAL-SITE-FEASIBILITY-AND-START-UP-DATA-AVAILABILITY-AND-COMPLETENESS-FOR-SHARING-WITH-THE-USG
REQUEST FOR INFORMATION
BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY/INFLUENZA AND EMERGING INFECTIOUS DISEASES DIVISION (BARDA/IEIDD)
DATE: October 10, 2019
TITLE: CLINICAL SITE FEASIBILITY AND START UP DATA AVAILABILITY AND COMPLETENESS FOR SHARING WITH THE USG
RFI No: RFI-20-09232019 Site Startup Data-0001
Description
1.1 The Influenza and Emerging Infectious Diseases Division (IEIDD), in support of the Biomedical Advanced Research and Development Authority (BARDA), is seeking information regarding the availability of clinical site selection and performance data from therapeutic clinical trials in infectious disease. The intent to use this data to analyze multiple site variables to increase the efficiency of clinical trials by identifying high and low performing clinical sites early in the startup process.
1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY
IEIDD is issuing this RFI solely for information and planning purposes - it does NOT constitute a Request for Proposal (RFP), a promise to issue a RFP, or a commitment to issue any type of solicitation in the future. This RFI does not commit the United States Government (USG) to contract any supply or service whatsoever. At this time, IEIDD is not seeking development proposals and will not accept or review unsolicited proposals received.
The USG will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party's expense. Submission is voluntary and is not required to propose to a subsequent solicitation on this topic (if any).
If IEIDD chooses to release a solicitation in the future, it will be summarized on the Federal Business Opportunities (FedBizOpps) website and the Office of the Assistant Secretary for Preparedness & Response (ASPR) website at https://www.medicalcountermeasures.gov/. It is the responsibility of the potential responder to monitor these sites for additional information pertaining to any potential requirement.
1.0 Background
Within the USG, the Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, and natural exposure(s) to pandemic influenza and emerging infectious diseases.
BARDA supports the development of the therapeutics for patients hospitalized with an influenza infection. Costs associated with conduct of clinical trials have been increasing for all clinical areas but particularly for hospitalized studies involving infectious diseases. The performance of the clinical sites that enroll these trials are operationally constrained by seasonality and severity of the disease. The inefficiency of clinical sites in terms of enrollment over time, where many sites that participate do not enroll any patients in clinical trials that extend over multiple years, is a significant drain on resources. As part of an ongoing effort to refine and improve the conduct of clinical studies that BARDA supports we are interested in developing algorithms that could be used to identify sites either prior to or soon after site activation, that either may enroll well, or may struggle with enrollment. The data will also be used to analyze if high performing site can be identified and additional resources can be devoted to obtain better enrollment.
For this RFI, we are seeking information from clinical research organizations or industry sponsors on their ability to provide a complete data set that includes data collected during feasibility and site start up on site location, type of site, site staff, patient demographics, site clinical research experience and facilities. Data elements such as the time it takes a clinical site to respond to the feasibility questionnaire, the number of comments made on the protocol synopsis during feasibility, the timing of all responses in the startup process, the number of staff available for the specific study and the length of clinical trial agreement negotiations are also of interest. Performance indicators that facilitate the evaluation enthusiasm of the investigator and study staff could provide interesting data as well.
BARDA would be interested in having all site information, but if complete site details cannot be shared, each site would need a unique identifier so that if a particular site has participated in multiple studies it can be easily identified. Other site demographics we are interested in include city, state, country, type of site, type of practice, clinical research experience and history of research with the CRO and sponsor.
Issues in clinical trial enrollment plague both complicated hospital studies and outpatient studies. In this case, a complicated hospital study would be defined as a phase 2 or 3 interventional study with an industry sponsor and at least 100 clinical sites. Subjects would be expected to remain in the hospital for at least 48 hours post-randomization, and data collection would occur at least twice daily while hospitalized. Overall follow-up with the patient would last at least 30 days. An eligible outpatient study would meet the following criteria: a phase 2 or 3 interventional study with an industry sponsor, involve at least 100 clinical sites, have at least 3 follow-up visits after randomization and overall follow-up would last at least 14 days.
If data were shared with the USG, the raw data would remain confidential within the USG. It is expected that the results of the analysis and broad data descriptions would be published in the peer reviewed literature and discussed in public meetings. Specific site information would not be made public.
2.0 Requested Information
The USG is seeking information and recommendations from clinical research organizations and industry sponsors on the data available and potential collaborations:
1. Willingness to share feasibility and site start-up tracking information with the USG
2. Number of clinical studies available in your database that meet the criteria for a complicated hospital study and outpatient study (outlined in Section 2.0)
a. How many infectious disease studies meet the criteria?
b. How many seasonal studies meet the criteria?
3. Are the following data fields collected routinely:
a. Timing of response to feasibility questionnaire (can be in the form of date sent and received)
b. Did the site provide feedback or concerns about the protocol during feasibility?
c. Site self-assessment of enrollment projections at feasibility
d. Timing of non-disclosure agreement signing
e. Timing of clinical trial agreement negotiations
i. Did CTA negotiations have to be escalated to senior management at the sponsor?
ii. Did the site ask for unreasonable compensation for their work?
f. Ease of scheduling the site selection and site initiation visits (can be in the form of first contact to actual date of visit)
i. Was the site prepared for the visits (all equipment and staff available for inspection and training)?
g. Does the site need extra equipment for the study?
h. Timeline for IWRS and EDC account activation?
i. Number of site staff to be trained on the protocol
i. Number of sub-PIs
ii. Number of research study staff
iii. Number of study coordinators
j. Are the site staff available 24 hours a day, 7 days a week for enrollment?
k. How many clinical studies is the site currently involved in?
i. Are there competing studies at the site?
l. Site recruitment strategy?
i. Does the site use the Emergency Department or Urgent Care satellite sites to identify potential subjects?
m. Does the site use a central or institutional IRB?
i. Did site staff coordinate institutional IRB submission?
ii. Length of time for IRB approval
n. Site demographics
i. Location
ii. Type of site (public, private, professional research, etc.)
iii. Type of practice (family medicine, endocrinology, etc.)
iv. Number of beds
v. Experience with clinical research, with the specific CRO and/or sponsor and in the disease area of interest
o. Final enrollment and screening data
i. Quality of enrolled patient data - number of protocol deviations per subject enrolled
4. Uniformity of the data - for each field above answer the following questions:
a. Does all of the data use the same format in the same tracker?
b. Are the same data formats used for all studies?
5. Are there other data fields that are collected in a uniform manner that could be included? If so, what are they? Do you recommend specific data fields over others?
6. Completeness of data
a. For any study how complete are the data fields in the site start-up tracker as a percentage?
b. What percentage of sites in the tracker have all data fields complete?
7. What would be the expected cost to the USG to acquire feasibility and site start-up information from at least 20 hospital and 20 outpatient completed clinical studies?
a. What would be the cost of 50 hospital and 50 outpatient clinical studies?
8. Have you done this sort of analysis already? If so, are you willing to share the results with BARDA?
4.0 Responses
4.1 Interested parties are requested to respond to this RFI with a white paper.
4.2 White papers shall adhere to the following:
• 8.5 by 11 inch paper in a format compatible with either the Microsoft Office software package or Adobe Acrobat; and
• Response shall be limited to 10 pages for Section 2 and submitted via email only to the individual(s) identified in Section 6.0 below
Proprietary information, in any form, should be minimized and MUST BE CLEARLY MARKED. To aid the USG, please segregate proprietary information. Please be advised that all submissions become USG property and will not be returned.
Information marked as "Proprietary" obtained in response to this RFI will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, applicable law and HHS regulations.
4.3 Section 1 of the white paper shall provide administrative information, and shall include the following at a minimum:
4.3.1 Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number and e-mail of designated point of contact.
4.3.2 Recommended contracting strategy
4.3.3 Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business.)
The North American Industry Classification System (NAICS) Code(s) are as follows:
325412 - Pharmaceutical Preparation Manufacturing; and
325414 - Biological Product (except Diagnostic Manufacturing.)
4.3.5 The facility security clearance of the responder (if applicable.)
The number of pages in Section 1 of the white paper shall not be included in the 10-page limitation, i.e., the 10-page limitation applies only to Section 2 of the white paper.
4.4 Section 2 of the white paper shall answer the issues addressed in Section 3.0 of this RFI and shall be limited to 10 pages.
5.0 Industry Discussions
BARDA representatives may or may not choose to meet with potential responders. Such discussions would only be intended to get further clarification or possible capability to meet the potential USG need.
6.0 Submission
Electronic responses to this RFI are due no later than:
12:00 PM EDT on December 19, 2019
Your white paper shall be submitted to the following individual.
Wendell Conyers, Supervisory Contracting Officer
Division of Contracts Management and Acquisition (DCMA)
Biomedical Advanced Research and Development Authority (BARDA)
E-mail: Wendell.conyers@hhs.gov
Please include RFI No RFI-20-09232019 Site Startup Data-0001 in the subject line of all correspondence.
All technical and administrative correspondence and questions regarding this announcement shall also be submitted to the above email address.
BARDA intends to use electronic mail for all correspondence regarding this RFI.
7.0 Summary
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide feedback on CLINICAL SITE FEASIBILITY AND START UP DATA AVAILABILITY AND COMPLETENESS FOR SHARING WITH THE USG. The information provided in the RFI is subject to change and is not binding on the USG.
BARDA has not made a commitment to procure any items or services, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submission become USG property and will not be returned.
This RFI is in accordance with FAR 52.215-3 Request for information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only.
Archiving Policy:
Manual Archive
Allow Vendors to Add/Remove From Interested Vendors:
Yes
Allow Vendors to View Interested Vendors List:
Yes
Wendell Conyers, Supervisory Contracting Officer, Phone (202) 692-4784, Email wendell.conyers@hhs.gov
