Proposal to Create New HL7 Technical Committee

Proposed Name

Clinical Research Regulatory Information Management Technical Committee

Rationale

This Committee is being proposed by the existing HL7 CT-SIG to manage all of the standards work related to therapeutics (drugs), clinical research and associated regulations. This Technical Committee would attempt to achieve the collaborative development of standards in this arena by increasing participation from several groups with a common goal towards healthcare and biopharmaceutical industry standards, including but not limited to HL7, CDISC, FDA, VA, NCI, ICH, NLM. This TC would address projects identified by the original CT-SIG and new/existing projects identified more recently at the past two Working Group Meetings of the CT-SIG.

Proposed Vision

To facilitate the availability of safe and effective therapies for humankind by improving the processes and efficiencies associated with regulated clinical research.

Proposed Mission

Develop standards to improve or enhance the information interchange involved in the clinical research and drug development processes; define messages, document structure, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of information to support the research and regulatory evaluation of the safety and efficacy of therapeutic products or procedures.

Proposed Projects for Standardization through this new Technical Committee

  • Protocol and Study Documents – (R.Kush)
  • Standardized representations of the protocol, including eligibility requirements, and that provide support for assessment of protocol compliance
  • Clinical trials data collection (e.g. CRFs, EMR, eCRF)
  • [HL7 Clinical Guidelines, CDISC, NCI-PATS]
  • Regulatory Applications and Standard Submission Documents – (L. Quade)
  • Table of Contents
  • Submission Forms
  • Submission Documents
  • [ICH, FDA]
  • Standardized Domains for Clinical Research Data – (W. Kubick)
  • Standards related to analytical and reporting of clinical trials data
  • [CDISC, NCI, FDA, CDC-NACCR, Professional Societies]
  • Medication Information – (R. Levin)
  • A representation of standards for interchanging structured Medication Information; labeling
  • [FDA, NLM, VA, HL7]
  • Surveillance Information – (B. Tardiff)
  • Representation of standards for transmitting a standardized set of pre and post-marketing safety reports (adverse events) among different organizations
  • [ICH, MedWatch-FDA, CDC]

Specific aspects each of the above projects should address with respect to their standards development activities include the following:

  • Messaging, including real-time interchange
  • Standard Metadata
  • Content of the Models
  • Document Structure
  • Terminology
  • Harmonization within HL7, CDISC, ICH, NCI and other formal and informal groups, as applicable

Stakeholders

The process of producing new therapeutic products and getting them on the market involves many stakeholders and handoffs of information (documents, data, etc.) among multiple stakeholders, including but not limited to biotechnology and pharmaceutical companies, clinical laboratories, regulatory and other governmental agencies, healthcare providers, technology providers, service providers, academia, investigative sites, device companies, and especially patients.

Benefits of the Technical Committee

  • improve dissemination of and access to information concerning clinical research and therapeutic safety throughout the healthcare and biopharmaceutical industries
  • facilitate interchange of information among all stakeholders to increase access to safety and efficacy information and streamline the development and approval of new therapies
  • encourage the development of a shared knowledge base about drug indications and relationships that would support intelligent software modules
  • increase coordination of standards activities across government agencies [e.g. NLM, CDC, VHA, DOD, CMA(HCFA)] and other organizations actively working to develop such standards
  • provide a consistent approach throughout the drug regulatory agencies to promote more cost effective exchange of information from health care providers with these agencies, including safety surveillance data
  • use consistent drug codes to decrease cost of developing and maintaining drug ordering software and reduce errors in medication prescribing and administration
  • improve the review environment for regulatory submissions for new marketing applications for biopharmaceuticals or other therapies
  • attract additional resources to work together to further the goals of HL7, ICH, FDA, CDISC; attract more pharmaceutical companies and other stakeholders in the biopharmaceutical industry to work with HL7
  • link together work currently occurring among different groups (academia, biopharmaceutical companies, government, consortia and others) towards common goals, particularly healthcare and clinical research, thus minimizing diverse efforts in the development, accreditation and maintenance of standards; facilitate harmonization among others within HL7 and CDISC with respect to efforts towards common standards on a global scale

Accomplishments of the HL7 CT-SIG during 2001-2

  • Provided cross-education among CDISC and HL7 members
  • Provided HL7 RIM tutorials (3) for CDISC teams and leadership
  • Presentations from CDISC to HL7 leadership
  • Attended joint meetings in 2001 – all three HL7 Working Group Meetings (WGMs)
  • Attended CT-SIG meetings January 2002
  • Created CT-SIG
  • Defined mission and projects
  • Initiated projects to define HL7 messages for two CDISC models (LAB and ODM) and discussed potential accreditation process as RIM messages
  • Discussed potential accreditation process for CDISC SDS metadata model (collaboratively developed with FDA participation) – as an informative document
  • Developed plan to propose to FDA use of HL7 model for ECG, along with DICOM input and CDISC metadata harmonization
  • Maped the CDISC high priority information into the HL7 information space
  • Developed message (ongoing) for CDISC LAB content model in HL7 Version 3 RIM- rMIM presented
  • Analyzed HL7 RIM-CDISC ODM - comparison, contrast and proposed next steps developed by ODM and HL7 representatives
  • Defined and documented the common interests of CDISC and HL7
  • Developed proposal in January 2002 to expand these interests to include FDA and ICH and potentially NCI group(s)
  • Developed proposal to upgrade CT-SIG to a technical committee to incorporate additional activities and developed list of additional activities

Additional Comments Relevant to a new HL7 Technical Committee

In addition, FDA is working with VHA on a National Drug Formulary Reference Terminology; work for this is being coordinated with HL7 and could be encompassed under the terminology sector.

NCI has done much work on Common Data Elements (CDE) that are relevant to oncology and has been associated with CDISC since its inception. It was proposed at this WGM, by an NCI representative, that a group be formed group to address issues regarding standardizing reference terminology for oncology – common data elements. Suggestions/options were to tag on to NLM and they can then bring their recommendations to HL7 to help with consensus-building. Also, LOINC has a function with a maintenance activity and SDS is interested in defining further domains relevant to therapeutic areas and there are other groups developing oncology terminologies. The issue to be addressed is where to go to get harmonization of such related terminologies. This activity to harmonize across different groups with respect to oncology terminology could be further discussed and potentially be included within the applicable SIG(s) under the newly proposed HL7 Technical Committee.