News in Clinical Trials at Westat

2012

2011

Other Westat News

05/10/12

Westat Staff Attend NHLBI-UnitedHealth Steering Committee Meeting

Westat staff Nancy Dianis, Tracy Wolbach, and Diana Meyer joined other National Heart, Lung, and Blood Institute (NHLBI)-UnitedHealth Global Health Initiative members at the 6th Semi-Annual Steering Committee meeting in Cape Town, South Africa, in April.

The meeting's focus was threefold

  • Receive progress reports from the 11 Centers of Excellence (COEs) on their research initiatives directed at combating noncommunicable cardiovascular and pulmonary diseases (CVPD)
  • Review the network's research efforts in combating chronic disease
  • Provide an opportunity for discussions on collaborative research

The NHLBI-UnitedHealth Global Health Initiative's goal is to reduce the burden of noncommunicable CVPD by building research and training capacities at 11 emerging COEs in developing countries (Argentina, Bangladesh, China, Guatemala, India [2 centers], Kenya, Peru, South Africa, Tunisia, and Northern Mexico).

All of the COEs are located within institutions that also serve as Fogarty International Clinical Research Fellow or Scholar sites, which are top-ranked National Institutes of Health-funded research centers in developing countries.

Each COE is supported by an academic institution, known as a developed country partner (DCP), that serves as a mentor to the COE staff. DCPs assist with developing new clinical infrastructure to combat these debilitating diseases through a global approach.

Westat serves as the administrative coordinating center to provide oversight for the network and manage day-to-day project logistics to allow NHLBI, the COEs, and the DCPs focus on research and training activities.

Westat has supported efforts to

  • Develop a performance monitoring plan and collect data to track program achievements
  • Develop a Manual of General Operations and network standard operating procedures
  • Manage network-wide training
  • Identify and implement communication options suited to each country's technological capacity
  • Facilitate domestic and international semi-annual network meetings
  • Manage regulatory documents
  • Maintain network web site and discussion forums

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05/09/12

Westat's Multidisciplinary Project Management Skills Featured at User Group Meeting

Westat staff gave presentations at a recent user group meeting that illustrated our successful multidisciplinary project management approach in clinical data management, information technology, and clinical trial operations. The presentations were part of the 2012 Americas Medidata User Group meeting in Philadelphia, Pennsylvania, May 1-3, 2012.

The following presentations were given by Westat staff.

Whitney Smith. (Presentation).
Consensus Building and Standardization to Optimize Sharing and Tools.
Ms. Smith's presentation discussed standardization and consensus building as key strategies for success in very large collaborative development and implementation projects. Her focus was on the organizational and management challenges of working with a large stakeholder community.

Jayan Nair. (Presentation).
Implementing a Federated Authentication System to Access iMedidata.
Mr. Nair's presentation explained how a single sign-on solution was developed to supported federated clinical databases using Security Assertion Markup Language (SAML) as the standard data exchange medium. Westat developed an approach of creating "starter kits" to jump-start implementation in the Java and .NET environments used by the cancer Cooperative Groups.

Through the Cancer Trials Support Unit (CTSU), a contract with the National Cancer Institute (NCI), Westat provides a broad package of support services to cancer Cooperative Groups, their member sites, and other clinical trials sponsors. The CTSU maintains rosters of investigators and institutions participating in NCI-sponsored clinical trials and collects institutional review board approval documentation for sites participating the several hundred clinical trials conducted in this environment.

Westat has recently led the offering of support services for a clinical data management system software application, Medidata's Rave®. Westat has leveraged the existing infrastructure, both technical and procedural, to provide an integrated service gateway to this application. Westat provides program management leadership; coordinates the development of best practices, systems integration service, and help desk support services to more than 20,000 users and 3,000 research sites; and develops clinical databases for oncology studies.

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11/21/11

Westat Attends CDC Cooperative Agreement Partners Meeting

Westat staff Victoria Kioko, Moussa Sarr, Ph.D., and Fatima Jones, Ph.D., joined other members at the second annual Centers for Disease Control and Prevention (CDC) Cooperative Agreement partners meeting in Atlanta, Georgia, earlier this month.

Members include the newly formed African Society of Laboratory Medicine (ASLM) and the Laboratory of Bacteriology and Virology at Le Dantec University Hospital, Cheikh Anta Diop (LBV/CAD) University.

ASLM is headed by John Nkengasong, Ph.D., Chief of the Global HIV/AIDS Program's International Laboratory Branch at CDC. ASLM is Pan-African professional body working to advocate the need for laboratory strengthening and capacity building within the African continent.

Westat has supported efforts to

  • Develop an HIV-related external quality assurance and proficiency testing program for all francophone African countries
  • Promote the accreditation of medical laboratories throughout the African continent

Westat provides administrative, laboratory, and technical support for LBV/CAD. In the first year of the cooperative agreement, 25 laboratories were selected to participate in the proficiency testing program. More than 400 laboratories across the African continent are expected to be enrolled in the next 5 years.

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10/19/11

Westat Staff Participate in Clinical Research Society Conference

Westat staff participated in the Annual Society of Clinical Research Associates (SoCRA) conference in San Diego, California, September 23-25, 2011. Nearly 1,000 clinical research professionals attended the meeting, which focused on continuing education and professional development.

Westat staff presented the following material:

Jennifer Bryant. (Presentation.)
Optimizing the Site Monitor Training Experience.

Ms. Bryant's presentation highlighted enhancements made to Westat's approach for training new site monitors. These enhancements include introducing a standardized process for evaluating the staff member's experience and capabilities in order to tailor an individualized training plan, and assigning specific objectives for the trainee at each on-site monitoring training visit.

Georgine Price and Barbara Driver. (Poster.)
Efficient Approach for Developing Effective Case Report Forms.

The poster outlined our team approach for the process of developing clinical study case report forms (CRF). It included the process of establishing a CRF development team (CDT) comprised of protocol, data management, biostatistical, and systems experts. It also addressed the procedures the CDT follows to promote the development of well-designed CRFs, thereby, improving the quality and completeness of data collected.

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06/29/11

Luceli Cuasay, Dr.P.H., Discussed Minority Health Needs at Cancer Center Workshop

Westat's Luceli Cuasay, Dr.P.H., gave a presentation on the health profile of Asian Americans at the 9th Annual Disparities in Health in the Global Context Summer Workshop at the University of Texas MD Anderson Cancer Center in Houston, Texas, on June 22.

The goals of the workshop were to provide a comprehensive approach to reduce the impact of chronic disease as it impacts health disparity and public health, and provide attendees with a broad base of knowledge related to a bio-psychosocial approach in addressing health disparities.

Dr. Cuasay's presentation was titled, Health Needs of Asian and Pacific Islander Americans: Stories from the Model Minority. It was part of the Health Disparities, Social Determinants & Obesity session.

"The Model Minority stereotype presents challenges in addressing health disparities," noted Dr. Cuasay. "Despite their favorable socioeconomic status, major health issues, such as heart disease, diabetes, and cancer, persist for Asian Americans. They are the fastest growing race in the United States in the last decade. It is increasingly important to understand their health status, behaviors, attitudes, and needs; design culturally and linguistically appropriate programs; and improve access to care. The role of researchers, health care professionals, and community leaders is critical in reducing health disparities."

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05/20/11

New, Simpler TB Treatment Is Biggest Breakthrough in Decades; Westat Supported Study

Latent tuberculosis (TB) treatment usually requires 9 months of daily pill-taking, but a new study, supported by Westat, shows that once-a-week drugs for a 3-month period work just as well.

The Centers for Disease Control and Prevention has just released data regarding this clinical trial that tested the effectiveness of a new preventive TB treatment regimen (using currently available anti-TB drugs) among persons with latent TB infection who are at high risk for progression to TB disease.

The multicountry clinical trial results [*] showed that a supervised once-weekly regimen of rifapentine and isoniazid taken for 3 months was just as effective as the standard self-administered 9-month daily regimen of isoniazid, and was completed by more participants.

The Tuberculosis Trials Consortium (TBTC) Monitoring Coordinating Center has been supported by Westat for 13 years. Westat monitors clinical sites and protocols; assists in developing protocols, procedures, and related materials; and conducts protocol education and training. We also provide statistical consultation, coordinate annual meetings, and manage the TBTC web site.

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05/02/2011

Nancy Dianis to Participate at Clinical Research Conference

Nancy Dianis, a Westat Vice President and an Associate Director of the Clinical Trials Area, will moderate a conference session about challenges faced by contract research organizations at MAGI's Clinical Research Conference [*] in Philadelphia, Pennsylvania, May 22-25, 2011. The conference will include a broad range of topics related to clinical research. Speakers include representatives from the pharmaceutical industry, research institutes, and government agencies.

MAGI is an acronym for Model Agreements & Guidelines International, which has more than 6,000 members who represent clinical research sponsors, sites, and CROs. Their objective is to standardize best practices for clinical research operations, business, and regulatory compliance.

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04/27/2011

Society for Clinical Trials Meeting Includes Westat Staff

Westat staff will be participating in this year's Society for Clinical Trials (SCT) Annual Meeting(external site) [*]. The meeting will be held in Vancouver, British Columbia, Canada, May 15-18, 2011.

The SCT engages dialogue on important issues of the day facing clinical trialists. The theme for this year's meeting is the design and conduct of international trials, with a special emphasis on Asia.

Westat staff members will be available following the presentations/poster sessions to provide meeting attendees an opportunity to learn about our projects and capabilities.

The following Westat staff will be presenting at the meeting:

Brenda Brewer. Poster.
Creating and Supporting a Productive Environment for Ancillary Study Development in a Multi-Center Trial.
Kathy Clingan. Poster.
A Unique Web-Based Tool for Performing and Tracking Data Quality Assurance Tasks in a Multi-Center Study.
Nancy Payte. Presentation.
Solutions for Monitoring Medical Record Abstraction Quality in a Multi-Center Study.
Jennifer Rosenbaum. Poster.
A Complex Web-Based Structure for Coordinating Review and Tracking Progress of Ancillary Studies in the National Lung Screening Trial.
Jennifer Rosenbaum. Poster.
An Efficient Web-Based Approach to Managing a Complex Cause of Death Review Process.

For more information:
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03/21/2011

Luceli Cuasay, Dr.P.H., Discussed ClinicalTrials.gov at Bio/Medical Technology Club Event

Westat's Luceli Cuasay, Dr.P.H., gave a presentation about ClinicalTrials.gov at the Bio/Medical Technology Club (BMTC) of Houston meeting last month. Westat recently became the first Silver Sponsor of the BMTC. The BMTC's mission is to foster the development and growth of biotechnology and life sciences in Houston, Texas.

The Food and Drug Administration Amendments Act of 2007 requires sponsors of clinical trials to register and post results in a public database: ClinicalTrials.gov [*]. The purpose of the database is to provide complete results, and enhance patient access and understanding of clinical trials.

Organizations such as the World Health Organization, the International Committee of Medical Journal Editors, and individual states, as well as regulatory agencies, have also imposed registration and results publication requirements.

Dr. Cuasay's presentation highlighted:

  • History of the ClinicalTrials.gov
  • Applicable clinical trials to register
  • How protocols are submitted and updated
  • Information required to be posted
  • Benefits of registration

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03/16/2011

Combination Therapy Can Reduce HIV Transmission to Newborn Infants by 50%

A combination antiretroviral (ARV) drug regimen provided to HIV-exposed infants within the first 2 weeks of life can reduce the risk of HIV transmission by approximately 50 percent as opposed to a single drug regimen. These are the initial results of a study conducted for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Westat served as the coordinating and data center for the trial.

The results are expected to help further establish best treatment practices both domestically and internationally.

Key elements of the study [*] are as follows:

  • More than 1,700 infants were enrolled from 17 domestic and international sites.
  • The trial spanned a 6-year study period.
  • Infants were born to HIV-infected mothers.
  • Mothers had not been treated with ARV therapy prior to delivery.
  • The trial compared the effects of combination drug treatment regimens to a single drug treatment regimen:
    • Two-drug regimen (Zidovudine and Nevirapine) versus one drug (Zidovudine)
    • Three-drug regimen (Zidovudine, Nelfinavir, and Lamivudine) versus one drug (Zidovudine)

"This study shows combination drug regimens such as these can significantly cut the spread of HIV from mother to infant. This is particularly important when antiretroviral treatment during pregnancy isn't possible," noted Margaret Camarca, the Westat project director of the study. "We are extremely proud to have played a role in this landmark research study."

Results were presented at the 18th Conference on Retroviruses and Opportunistic Infections, held February 27-March 2, 2011, in Boston. A fuller analysis, with more detailed results, will be prepared for publication in a peer-reviewed journal within the next several months.

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02/18/2011

Westat Participates in Clinical Operations Conference, Highlights Research in Costa Rica

Westat was a corporate sponsor of the Cambridge Healthtech Institute's Second Annual Summit for Clinical Ops Executives (SCOPE), which took place in Miami, Florida, from February 7-9, 2011.

The conference offered opportunities for business development and promoted interaction with industry leaders, clinical operation directors, regulatory authorities, and investigators. Westat staff participated and highlighted the opportunities of conducting clinical research in Costa Rica, where the company has one of its six international offices.

The clinical operations summit focused on five themes:

  • Global site selection, feasibility, assessment, operations, and site management
  • Electronic data in clinical trials
  • Drug development Latin America
  • Clinical trial forecasting, budgeting, and project management
  • Patient recruitment in clinical trials

Two Westat staff members participated at the summit:

  • Isabel Trejos, PharmD, MSc, a Westat project manager/Latin American Business Development specialist
  • Yolanda Bertucci, MD, MPH/MCH, a Westat project manager

Dr. Trejos's presented Planning and Conducting Clinical Trials in Costa Rica. Her presentation:

  • Provided a general overview of the Costa Rican research environment,
  • Outlined specific examples of local challenges to international clinical research, and
  • Discussed strategies for overcoming these challenges.

For more information:
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