Technical information

Sixteenth Programme Report

Publications

TDR technical units produce a wide range of documents for technical audiences and made available in hard copy and electronically. TDR also produces brochures and information packages for general audiences.

In the area of new knowledge, TDR cosponsored, together with the US National Institute of Allergy and Infectious Diseases (NIAID), the Anopheles gambiae genome poster, part of the special issue of Science that published the full sequence of this vector’s genome.[1] In recognition of the role played by the Special Programme in the coordination of this accomplishment, an article by TDR opened the series of articles on the mosquito genome.[2]

Three publications series in social, economic and behavioural research were initiated during the biennium:

  • Special Topics in Social, Economic and Behavioural Research. This series will address topics such as ethical, legal and social issues concerning genetically modified disease vectors in public health, gender and infectious disease, cultural beliefs and infectious disease control, community participation, globalization and infectious disease, and health-seeking behaviour.
  • A Final Report Series, initiated in 2002[3] and comprising a peer-reviewed selection of leading research projects.
  • A book series which will address topics such as the behavioural and social aspects of malaria and its control.

A general brochure[4] outlining TDR’s priority areas in social, economic and behavioural research was also produced, and two special issues of the international journal Health Policy and Planning on health sector reform (see page 19) and one on health workers for change 5 were published under the coordination of a TDR staff member as guest editor.

TDR develops guidelines and training materials aimed at facilitating the development and introduction of new drugs, vaccines, diagnostic procedures, and other tools, in tropical diseaseendemic areas. A handbook on good laboratory practice (GLP),[6] designed as an aid for those countries wishing to upgrade their laboratories to GLP status, and GLP training manuals for trainee and trainer,[7] which provide resource materials for GLP training, were published in 2001.

The GLP guidelines were the most popular download from the TDR website in 2002. Also published was a draft handbook on quality standards in basic biomedical research,[8, 9] which proposes general standards for laboratories working to explore and discover substances with potential for developing into new drugs and other products; a handbook on non-clinical safety and toxicology testing is in preparation.

The TDR-sponsored training manuals for good clinical practice (GCP) continued to be widely used, particularly in sites used for clinical trials supported by TDR. An updated version[10] provides a regulatory framework within which clinical trials should be conducted to ensure accordance with international standards. Guidelines for establishing institutional ethical review have been translated from English into French, Spanish, Turkish, Russian, Thai and German, while guidelines for monitoring institutional review were published in 2002[11] to facilitate procedures for developing quality and transparency in ethical review.

A Strategic Initiative for the Development of Capacity for Ethical Review (SIDCER)[12] was established to encourage development of regional networks and forums concerned with institutional ethical review.


References:

1 Science, October 2002, 298.

2 Morel CM et al. The mosquito genome – a breakthrough for public health. Science, 2002, 298(5591):79.

3 Jackson S, Sleigh A, Liu X-L. Economics of malaria control in China: Cost, performance and effectiveness of Henan’s consolidation programme. Report Series No. 1, TDR/STR/SEB/RP/02.1

4 Strategic social, economic and behavioural research. WHO/STR/SEB/02.1

5 Health Workers for Change: A quality of care intervention. Health Policy and Planning, 2001, 16 (Suppl. 1).

6 Good laboratory practice: Quality practices for regulated non-clinical research and development. TDR/PRD/GLP/01.1C

7 Good laboratory practice: training manual (TRAINEE). A tool for training and promoting good laboratory practice (GLP) concepts in disease endemic countries. TDR/PRD/GLP/01.1B Good laboratory practice: training manual (TRAINER). A tool for training and promoting good laboratory practice (GLP) concepts in disease endemic countries. TDR/PRD/GLP/01.1A

8 Quality standards in basic biomedical research. TDR/PRD/QSBR//01.1

9 also published in full in: The Quality Assurance Journal, 2002, 6(2):91-102.

10 Workbook for investigators. TDR/PRD/GCP/02.1b

11 Surveying and evaluating ethical review practices. A complementary guideline to the operational guidelines for ethics committees that review biomedical research. TDR/PRD/ETHICS/2002.1

12 http://www.sidcer.net/

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