HII, CDISC launch new project to harmonize health research guidelines

A Project to harmonize health research guidelines was launched today by the Health Improvement Institute (HII) in partnership with the Clinical Data Interchange Standards Consortium (CDISC).

"Over the years, different authors have been concerned about the quality of the medical literature, and hence, of health research. These concerns encompass the accessibility, relevance, and validity of research results. But, to date, there has been little effort to assure the quality of research designs and even less effort to measure studies' success," said Dr. Peter G. Goldschmidt, president of HII. "We believe that the time is now right for a project to establish a sustainable mechanism 1) to harmonize worldwide guidelines for health research, and 2) to promote their use in policy decision-making, practice, education, and research itself."

Project objectives are: 1) to establish an arrangements development committee, 2) to institute a sustainable mechanism to achieve the plan's purpose, 3) to create a map to define the scope of potential harmonization, 4) to inventory guidelines' elements, and 5) to develop consensus-based guidelines for guidelines.

To chart the way forward, an initial meeting of the arrangements development committee will be held in November, 2011, in Bethesda, Maryland. Its objectives are 1) to facilitate reaching agreement on organizational arrangements for a sustainable mechanism to harmonize health research guidelines, such as establishing a guideline harmonization organization, 2) to identity governance & funding of such mechanism, 3) to create resources that are needed to harmonize and to maintain worldwide guidelines for health research, 4) to establish a database of relevant guidelines and metrics, and 5) to promote marketing and uptake of health research guidelines. Experts -- representing every relevant aspect of the research enterprise, including guidelines developers, guidelines users (such as biopharmaceutical companies, academic researchers), and guideline use-facilitators (such as regulatory agencies and accrediting organizations) -- will be invited to participate in this initial meeting.