Links to RCT Information

Summer Institute on Design and Conduct of
Randomized Clinical Trials
Involving Behavioral Interventions

Last updated on:
June 4, 2004

Contact:
Dana Sampson
OBSSR

	Links to Information about RCTs
	Evidence-Based Behavioral Medicine Committee The purpose of the EBBM Committee is to establish an ongoing process to review developments in evidence-based behavioral medicine interventions and then to disseminate these findings to our scientific, clinical, educator, and student communities. Particular emphasis is placed upon RCTs.
	William T. Grant Foundation Works to Increase the Capacity for Conducting Group-Randomized Studies The Foundation is interested in supporting studies meant to improve the effectiveness of youth-serving systems, organizations, and programs. The issues and discussions are equally relevant to health-related group-randomized studies at all ages. This site has links to computer-software and to publications that are available for downloading.
	Implementing Randomized Field Trials The National Research Council publication called "Implementing Randomized Field Trials: Report of a Workshop" is available at http://books.nap.edu/catalog/10943.html. It is a short report intended for a range of audiences in education and education research about the practicalities of conducting trials in schools.
	Current NIH Funding Opportunities NIH Clincial Trial Planning Grant (R34) Program, October 16, 2003 NINDS Clinical Trial Planning Grant, July 7, 2001 NIDCR Clinical Trial Planning Grant, December 6, 2002 NIDCD Clinical Trial Planning Grant, August 27, 2002 NIDCD Investigator-Initiated Clinical Trials, August 27, 2002
	Advanced Training Institute in Health Behavior Theory The National Cancer Institute (NCI) will sponsor an intensive, 8-day session for early career investigators during July 10 to 18, 2004 in San Diego. The primary objective of the institute is to allow 25 attendees to extend their knowledge of and experience with the conceptual, methodological, and statistical underpinnings of health behavior theories. Lead instructors include researchers Neil Weinstein, Alex Rothman, Susan Curry, and Barbara Curbow. You must have a doctoral degree and have completed at least one graduate level course in the behavioral sciences and one graduate level course in statistics in order to be considered for acceptance. There will be a $400 registration fee to participate in the institute. Information and application available at http://www.scgcorp.com/ati2004. Contact: Andrew W. Hertel Department of Psychology University of Minnesota hert0053@umn.edu
	The CONSORT statement: Revised recommendations for improving the quality of reports of parallel group randomized trials.
	Society for Clinical Trials The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design and conduct of clinical trials and related health care research methodologies. Visit their HomePage for information about the annual meeting and membership.
	National Institute on Deafness and Other Communication Disorders NIDCD is interested in supporting behavioral RCTs. Selelct this link (requires Adobe Acrobat Reader) for more information.
	Small Clinical Trials: Issues and Challenges Although announced earlier this spring, the Institute of Medicine (IOM) report, "Small Clinical Trials; Issues and Challenges" has just recently become available on-line and through the NAS publications office. The report by the IOM Committee on Strategies for Small Number Participant Clinical Research Trials was sponsored by NASA and is the first comprehensive examination of the design and analysis methodologies and research needs for clinical trials with very small sample sizes, e.g. astronauts, rare disease, isolated and public health emergency populations that because of the small participant sample number (e.g., <5 to 100 or more individuals compared to thousands in large clinical trials) of available participants may not provide sufficient statistical power for traditional statistical analysis to advance conclusions that can be extrapolated to a larger population. The study recommends for clinical researchers, teachers, students, study sponsors, and others concerned with this important area a number of clinical design and analysis issues and challenges for consideration to enhance the value of clinical trials with small number of participants for any clinical research population with a small sample size. The report includes recommendations related to defining the clinical research question, tailoring the research design, use of several methods in the design and analysis of the study, and continuing research needs in study design and analysis to advance this rapidly developing and critical biomedical and clinical research need in drug, medical device and genomic clinical research development.
	The Campbell Collaboration The Campbell Collaboration is an emerging international effort that aims to help people make well-informed decisions by preparing, maintaining, and promoting access to systematic reviews of studies on the effects of social and educational policies and practices. The systematic reviews of research evidence, prepared and maintained by contributors to the Campbell Collaboration's Review Groups, will be designed to meet the needs of those with a strong interest in high quality evidence on "what works". These include members of the public who want to keep abreast of the best evidence on the effects of social and educational policies and practices, service providers, policy makers, educators and their students, and professional researchers. Campbell systematic reviews will be published electronically so that they can be updated promptly as relevant additional evidence emerges, and amended in the light of criticisms and advances in methodology.
	The Cochrane Collaboration The Cochrane Collaboration has developed in response to Archie Cochrane's call for systematic, up-to-date reviews of all relevant RCTs of health care. Cochrane's suggestion that the methods used to prepare and maintain reviews of controlled trials in pregnancy and childbirth should be applied more widely was taken up by the Research and Development Programme, initiated to support the United Kingdom's National Health Service. Funds were provided to establish a 'Cochrane Centre', to collaborate with others, in the UK and elsewhere, to facilitate systematic reviews of randomized controlled trials across all areas of health care.
	International Conference on Harmonization The site for the International Conference on Harmonization includes papers discussing a variety of topics related to clinical trials. Their work is pharmaceutical in orientation, but it is also of general interest and relevance.
	FAES Courses For NIH staff, the FAES offers a course on Clinical Trials Methodology. Check the bi-annual listing of courses for availability.
	NCI Resources: Conducting Clinical Trials Educational series of basic and advanced materials about clinical trials including: workbooks brochures slide shows videos This materials is intended for a variety of audiences.
	Other links? Please send suggestions for the posting of links to additional HomePages providing resources for the planning, implementation, and evaluation of randomized clinical trials, especially those involving behavioral and/or social interventions. Recommendations should be e-mail to abeles@nih.gov.