SOLICITATION NOTICE
B -- MATRICS India Validation Study
- Notice Date
- 12/7/2010
- Notice Type
- Presolicitation
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- NOI-12072010
- Archive Date
- 12/31/2010
- Point of Contact
- Liem T Nguyen, Phone: 3014358780
- E-Mail Address
-
ln18x@nih.gov
(ln18x@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Health (NIH), National Institute on Drug Abuse (NIDA) Office of Acquisitions, Station Support Simplified Acquisitions Branch on behalf of the National Institute of Mental Health (NIMH) intends to negotiate on a non-competitive basis and issue a purchase order to University of TX Health Science Center at San Antonio, San Antonio, TX 78229-3900, to conduct the on-going Cross-Cultural Utility of Intermediate Measures (CIM) study. The CIM Study is a part of continuing project of the ‘Treatment Units for Research on Neurocognition and Schizophrenia (TURNS) project that was competitively solicited and negotiated in 2003. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority of FAR 13.106-1(b)(1) and FAR 13.501 (a)(1) to use Simplified Acquisition Procedure for commercial items. The North American Industry Classification System Code is 541720 and the size standard is $7.0M. This acquisition is a firm-fixed-price; period of performance is to be fifteen (15) months from award date; and place of performance is in India. Schizophrenia is an illness characterized by cognitive deficits in the areas of attention, memory, and executive functions (Gold & Harvey, 1993; Green, 1996; Velligan et al., 1997). These cognitive deficits have been found to be related to impairments in role functioning in individuals with schizophrenia and are considered a core feature of this disorder (Green, 1996; Velligan et al., 1997). Efforts to improve outcomes in schizophrenia have increasingly focused on ways to address cognitive impairments with the ultimate goal of improving functional outcomes (Velligan et al., 2008a; Velligan et al. 2008b; Velligan et al., 2006; Bell et al., 2008; Wexler et al., 2005). The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative was designed to encourage the development of cognitive enhancing pharmaceutical agents for schizophrenia by developing a process by which a medication could receive an indication for the treatment of cognitive dysfunction in schizophrenia (Green et al., 2004; Nuechterlein et al., 2005; Buchanan et al., 2005; Nuechterlein et al., 2008; Kern et al., 2008). This initiative was collaboration among academicians, industry partners, and government agencies and resulted in recommendations for study design and the development of a consensus cognitive battery--the MATRICS Consensus Cognitive Battery (MCCB)-- to assess cognition in studies of novel compounds seeking this indication (MCCB Nuechterlein et al., 2008; Kern et al., 2008). As part of the MATRICS initiative, the Validation of Intermediate Measures (VIM) study was developed to assess the reliability, validity and utility of a number of intermediate measures that have faced validity for assessing functional outcome in schizophrenia. Because longer-term functional outcomes such as employment, or changes in marital status are not likely to be improved during the course of a typical clinical trial, the study focused on intermediate measures of functional capacity or everyday functioning that are thought be more amenable to change over this time period (Green et al., 2008). The goal of the VIM study was to select the measure or measures with the best psychometric properties for use in clinical trials of compounds designed to improve cognition in schizophrenia (Green 2009). Results supported the use of the UCSD Performance-based assessment (UPSA), the UPSA Brief and the Brief Version of the Test of Adaptive Behavior in Schizophrenia (TABS) for use as co-primary measures in clinical trials investigating medications for improving cognition. Concurrently with the VIM study, NIMH researchers conducted the Cross-Cultural utility of Intermediate Measures (CIM) study to investigate the cross-cultural applicability of these measures for use in international trials. The CIM study provided ratings of the cross-cultural adaptability of the VIM measures at 31 international sites in 8 countries. English-speaking PIs and frontline research staff familiar with conducting clinical medication trials were asked to make judgments on the Cultural Adaptation Rating Scale (C-CARS) regarding the extent to which each subscale of each intermediate measure could be applied to their culture and to subgroups within their culture based on gender, geographic region, ethnicity and socioeconomic status. This pilot identified problems for specific subscales on all the performance-based assessments across some of the countries. India, China and Mexico presented the greatest challenges in adaptation. Results of the CIM study suggested two potential ways to move forward for the development of a co-primary measure for use in international trials. The first option is to customize the best measure (UPSA Brief) for use in each country where the trial will take place. A second approach is to create a novel assessment tool with good psychometric properties that has been judged by expert clinical investigators as culturally appropriate. The CIM II study will investigate these approaches. The present study will examine a new measure the Functional Assessment Battery (FAB) composed of these 3 subscales; 2 from the UPSA and 1 from the TABS in a sample of patients at clinical sites in India. India was chosen as it was identified by raters as the most challenging country for adaptation. The following specific aims will be addressed. Aim 1: To examine psychometrics of the FAB and the UPSA brief (version studied in VIM), including: 1) Reliability (test-retest reliability and inter rater reliability), and 2) Repeatability (utility as a repeated measure within the time frame of a clinical trial; absence of practice effects that yield ceiling effects). Aim 2: To examine validity of the intermediate measures, including: 1) Correlation with measures that assess real-life functioning and 2) Correlation with cognitive performance: Study Design This study will be conducted only in India. A total of 130 patients with a diagnosis of schizophrenia who meets eligibility criteria will be assessed at baseline and again at four weeks. To obtain this number of subjects, each of the 5-7 participating sites will recruit between 18-28 participants total. Sites will be identified as those experienced in clinical trials for schizophrenia. All measures proposed to be translated into Hindi. Assessments Assessments will be administered at study entry and one month later. Interview measures will be completed first, followed by the functional capacity measures (UPSA-B and FABS). The order of administration of the UPSA-B and FABS will be counterbalanced. The MCCB will be administered after the functional measures. The performance-based intermediate measures will be re-administered at the week 4 assessment to assess test-retest reliability and utility as repeated measures. Symptoms will also be re-assessed. Data Management All data will be recorded on Clinical Report Form (CRFs) at the participating sites and faxed or emailed to the coordinating center at UTHSCSA for data entry and quality control. The statistical analysis will follow that of the VIM study. All data will be entered into relational databases meeting HIPAA requirements on an ongoing basis, using software that provides for double entry and numerous internal validity checks. Regular reports on data flow will identify any ongoing recruitment issues as they occur. Prior to statistical analyses, the data will be carefully inspected to alert us to such problems as unusual distributions, the desirability of transformations (e.g., logarithmic is often useful), missing data, outliers. Data Analysis Test-retest reliability will be assessed by calculating ICC's for the FAB and UPSA-B, Utility as repeated measures will be examined by examining the proportion of scores for all functional capacity measures at floor/ceiling at baseline and week 4, mean change from baseline, and order effects. The validity of the functional capacity measures will be examined by calculating the correlation between each functional capacity measure and the measure of real world functioning and between each functional capacity measure and the MCCB summary score. As part of the MATRICS scientific board, Dr. Velligan at UTHSCSA has been involved in the planning of all phases of the prior studies. The NIMH is not aware of any other group that has the unique skills and experience to carry out this research program. The study requires an intimate understanding of the instruments; an ability to train raters who are working in a different culture; relationships with investigators in India; an understanding of processes for monitoring the quality of conduct of this international study. Dr. Velligan carried out the cross-cultural validation of intermediate measures study (CIM I) that raised important concerns about the use of these instruments cross-culturally. She has relationships with the staff in India sites that can recruit the needed numbers of participants to investigate the reliability and validity of the novel battery of intermediate measures of functional outcome that she helped to created as a result of that trial. Based on the expertise and prior experiences that Dr. Velligan acquired through her work on the subject studies, it has been determined that Dr. Velligan and/or the University of Texas Health Science Center in San Antonio is the only qualified source to successfully perform the services. No other source will satisfy the agency's requirement. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, interested party believes it can meet the above requirement may submit a statement of capabilities on or before 2:00 PM local time Thursday, December 16, 2010 to Liem T Nguyen, ln18x@nih.gov. All information furnished must be in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered in and have valid certifications in the Central Contractor Registration (CCR), www.ccr.gov and the Online Representations and Certifications Application (ORCA) www.orca.bpn.gov. Please reference announcement number NOI-12072010 on all correspondence.
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