Standards Development

I. What is a standard?

“A standard for research with children is a set of guidelines established using a transparent approach either based on empirical evidence or consensus of experts. It consists of a list of recommendations for each of the steps to be taken in the process of design, conduct and reporting of research with children.”

II. Who will make the standard?

Each standard is developed by an  international team led by a convener. Teams are formed by invitation and subscription of members, and finally decided on by the Star Child Health Steering Group. Every team consists of about 6-8 persons with relevant methodological expertise. The composition of the Standard Development Groups reflects global representation. In each Standard Development group there will be at least two representatives from developing countries .The composition of the team in terms of professional background and expertise depends on the standard to be developed.

Team members are committed to the goal of the team. The convener has a leading role in writing the text of the standard, setting tasks for the entire team and for individual members, making sure that deadlines that have been agreed upon by the entire team are met. All team members are responsible for the quality of the text of the standard and its timely delivery. The convener regularly reports to the Steering Group about the progression of the team. The products of this process will be 1) a summary of the current evidence, 2) a list of recommendations for the process of design, conduct and reporting of trials with children, and 3) identification of gaps leading to a research agenda. Moreover, during the development of the standard a procedure for dissemination and implementation must be started. The process is managed by the Steering Group.

III. How will the standard be developed?

The process consists of the following steps:

1. Definition of the scope of the standard. What is needed? What is specific for pediatric research? What has already been addressed? Methods: survey among pediatric clinical researchers, review of the literature, consensus meeting of the standard development team.
2. Draft report including results of literature review and survey. This draft report contains a list of items about which recommendations can be made based on the available knowledge, a proposal for the recommendations, and a proposed research agenda.
3. Circulation of the draft report for comments among a larger group of researchers, regulators, representatives from pharmaceutical industry.
4. Adaptation of the draft report based on these comments, agenda for team discussion.
5. Meeting of the standard development team, get consensus about recommendations for standards and research agenda.
6. Publication of the standard in one or more journals.

The (draft) report containing the recommendations, the “final” standard, and the research agenda will all be published on the Star Child Health web site.
 

IV. How will the standard be implemented?

Once the Standards have been developed they are peer reviewed and updated. Then they need to be adopted world-wide to improve the quality of pediatric clinical research. With the help of: journals, research funding organizations, industry, regulators, reporting guidelines developers, and authors of research articles StaR Child Health can achieve this goal. We are developing a comprehensive plan for dissemination and implementation of our Standards for Research with Children. Please contact us and discuss opportunities for collaboration