The Department of Health and Human Services, National Institutes of Health has a requirement for Operations, Maintenance, and Modernization Support for ClinicalTrials.gov.

The National Library of Medicine (NLM), on the campus of the National Institutes of Health (NIH) in Bethesda, Maryland, has been a center of information innovation since its founding in 1836. As the world’s largest biomedical library, the NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of medical and biological research topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development, and training in biomedical informatics, computational biology, and health information technology. The NLM’s goal is to educate the current and next generation of innovators in biomedical informatics and data science, and, in addition to creating and disseminating databases covering a wide range of the biomedical bibliographic and genomic sequence space, its researchers develop gene analysis techniques, devise creative ways to search and analyze medical images, and apply advanced analytics to decode clinical narratives. In essence, the NLM looks to apply advanced analytics to addressing the public health and basic genomic research needs.

The NLM envisions a future in which data and information transform and accelerate biomedical discovery and improve health and health care. Achieving this vision will require the NLM to focus and enhance its research, development, training, and information services to make more biomedical data findable, accessible, interoperable, and reusable (the FAIR principles), to invent the tools and services to turn data and information into knowledge and insight, and to develop the workforce capable of doing so. It will require new forms of partnership and engagement with stakeholders in the public and private sectors, including researchers, librarians, health professionals, entrepreneurs and innovators, underserved communities, and the public. Within the NLM, the National Center for Biotechnology Information (NCBI) was established by Public Law 100-607 in November 1988 as a division of the NLM. The NCBI was given the following statutory responsibilities: (a) to design, develop, implement and manage automated systems for the collection, storage, retrieval, analysis and dissemination of information about molecular biology and genetics; (b) to perform research into advanced methods of computerbased information processing for analyzing the structure and function of biologically important molecules; and (c) to coordinate the gathering of biomolecular information both nationally and internationally. To carry out its mandate, the NCBI: 1. Conducts basic and applied research on fundamental biomedical problems at the molecular level using mathematical and computational methods. 2. Maintains scientific collaborations with the National Institutes of Health (NIH) institutes, academia, and other governmental agencies and international organizations. 3. Fosters the application of advanced computing technologies through state-of-the-art analysis tools and comprehensive and expertly annotated databases. 4. Coordinates access to a variety of databases and software for the scientific and medical communities. 5. Develops and promotes standards for data deposition and exchange, and biological nomenclature. The NCBI is specifically charged with building and providing public access to databases and search services vital to the medical and molecular biology communities and of key interest to the public as well. As part of the NCBI’s mission to collect, annotate and distribute all publicly available DNA sequences, it is a key repository for major large-scale sequencing projects and is actively involved in assembling and annotating the sequence data they produce.

Given its central role in genomic research, and the continuing need to make rapid advances in bioinformatics and computational biology, the NCBI has been charged with taking on special projects related to facilitating discovery, learning and advancements in areas of immediate interest such as surveillance of viruses and other pathogens, and areas that impact broad communities of the general public as well as researchers and medical professionals. These projects involve providing the next generation of tools and methods to the research community, facilitating their use and usefulness, as well as learning from an extensive engagement with the research community, and in turn translating the science to the health community and the public. Projects range from modernizing methods of data search and retrieval, gene annotation, evaluation of sequence quality, and comparative analyses, to developing new data infrastructures, user interfaces, and tools to result in an improved experience for the public.

ClinicalTrials.gov is an important NIH enterprise system, maintained by the NCBI, that serves a critical role in providing the NIH, researchers, the public, and others with up-to-date clinical research information. Such information has been reinforced during the COVID-19 pandemic. Congress mandated in 1997 that NIH create and maintain ClinicalTrials.gov. It reemphasized the importance of the system in 2007 by expanding NIH’s mandate to accept information from a broader set of clinical trials and include summary trial results information, and by empowering the Food and Drug Administration (FDA) to enforce compliance with data submission requirements. Public expectations and support related to clinical trial transparency have led to passage of other laws, regulations, and policies requiring registration and results reporting in ClinicalTrials.gov. These include regulatory requirements issued in 2016 and an NIH policy issued in the same year that establishes an expectation that all NIH-funded clinical trials be registered and have results reported to ClinicalTrials.gov. This NIH policy is one component of NIH’s broader efforts to enhance stewardship of NIH-funded clinical trials and to improve both accountability and transparency. ClinicalTrials.gov provides patients, family members, health care professionals, researchers, and other members of the public with convenient access to information on clinical studies for a wide range of diseases and conditions. As of July 2024, ClinicalTrials.gov has over 500,000 registered clinical studies sponsored by the NIH, other Federal agencies, non-profit organizations and private industry. More studies are added daily and an average of 850-1,200 studies are added per week. Studies listed in the database are conducted in all 50 states and in over 220 countries. ClinicalTrials.gov also includes a results database with results information for completed studies. The web site lists over 65,000 studies with results and 350 – 450 new results submissions are added per week. ClinicalTrials.gov hosts approximately 100,000 visitors daily. Clinical study information is submitted by sponsors responsible for conducting clinical trials, governmental or international agencies conducting clinical trials, and principal investigators who are responsible for conducting and coordinating the overall clinical investigation. To facilitate this, the NLM has developed the Protocol Registration and Results System (PRS) (http://clinicaltrials.gov/ct2/manage-recs/register ), a Web-based tool for submitting information to ClinicalTrials.gov. Information may also be transferred electronically to ClinicalTrials.gov through the PRS as an HTTP upload of an XML formatted file. Registered data providers enter information about their clinical trials, ensuring that the information is accurate, readily understood by members of the public, and updated in a timely manner. They serve as a point of contact for the ClinicalTrials.gov team and resolve questions associated with the information that is provided. NLM operates the PRS and the ClinicalTrials.gov website and administers a process to help ensure that records meet minimum quality control standards.

• The objective of this requirement is to support NCBI’s efforts to accomplish its mission of providing patients, their family members, health care professionals, researchers, and the public community with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions and within a timely manner
• The scope of this Task Order is to acquire complex professional specialized expertise, some of which is Information Technology (IT) services, to support the operations, maintenance, and modernization of ClinicalTrials.gov. In addition, the specialized expertise is required by NCBI to address and support the following NLM strategic objectives:
  • Accelerate discovery and advance health through data-driven research
    • Interconnect the resources of the NCBI/NLM digital information enterprise
    • Advance research and development in biomedical informatics and data science
    • Create a sustainable institutional and computational infrastructure
  • Reach more people in more ways through enhanced dissemination
    • Support research in biomedical and health information access methods and information dissemination strategies
    • Enhance information delivery through analytics-driven user engagement
  • Help build a workforce for data-driven research and health
    • Assure data science and open science proficiency
    • Increase workforce diversity

Non-It Portion of the Work Requirements:

• The Contractor shall be responsible for data quality control and related processes. This includes, but is not limited to: (1) review of individual records for apparent errors, deficiencies, internal consistencies (e.g., overall trial status must be consistent with status of individual locations; data in age field must agree with information in narrative description; analysis populations are consistent across results modules); (2) timeliness (i.e., contractor shall review dates and prompt data providers for updated information); (3) use of correct terminology; and (4) use of appropriate and understandable language

IT Portion of the Work Requirements:

• The contractor shall also provide comprehensive software design and engineering, system administration, and other ancillary IT support that NCBI requires for the continued growth and evolution of ClinicalTrials.gov databases and information systems. The scope of the design and development work will encompass the final stages of re-engineering, modernization, and longterm maintenance of the ClinicalTrials.gov and PRS database systems to improve their performance, reliability, and capability

ClinicalTrials.gov Modernization:

•  A modernization of the IT infrastructure is nearing completion to ensure that ClinicalTrials.gov provides the necessary flexibility to meet the growth in the number of clinical trials, in new protocols and in results reporting. This project focused on collecting and validating user requirements, modernizing core infrastructure and cybersecurity models, and implemented modern technical approaches in design, development and delivery. This special project maximized the value of ClinicalTrials.gov to the clinical research ecosystem, including NIH Institutes and Centers, FDA, and a broad range of users such as patients, healthcare providers, trial sponsors, and researchers. The effort is transitioning to a new database. The IT support is required to re-engineer and modernize key system components to improve performance, reliability, and capability concluding the reliance on the legacy system