WHO International Clinical Trials Registry Platform (ICTRP)

Transcription

1 ECPC Brainstorming Meeting on Establishing A European Clinical Trials Registry, Milan, May 30, 2005 WHO International Clinical Trials Registry Platform (ICTRP) Tikki Pang Research Policy & Cooperation World Health Organization Geneva, Switzerland,

2 Why register? Obligation to trial participants, the public Increase participation by patients, doctors, researchers Address analysis, reporting and publication biases Contribute to systematic reviews Speed access to results Increase effectiveness of research funding Impending increase in number of trials

3 Science , Science ,

4 Science, May 13, 2005, 308,

5 Registers exist, but. Designed for different purposes Compliance is low Field fragmented Systematic reviewers do not/cannot use them Awareness is low Not easy to search for all relevant trials Also: more registers coming!

6 Australia South Africa US Institute of Medicine IFPMA-pharma trials EDCTP (malaria, TB, HIV/AIDS) ECPC

7 Overall benefits of registration Ethical obligations addressed Improve access to research information Increase efficiency of the research process-advancement of knowledge Enhance transparency and accountabilityimproving public confidence in science Improve equity, ownership & participation Facilitate policy development

8 Why WHO? Global, neutral, independent Convening power Role in setting norms and standards in research, policy and practice GCP, ethics guidelines, ICD, research priorities Contribute to capacity building Commitment to achieving equity in health Political legitimacy, accountable to member states

9 "Clinical trials remain a major concern for us. South Africa is overwhelmed and our people are exposed to too many trials. Regulation, coordination and better access to information on which trials are going on are essential to protect the people" Manto Tshabalala Msimang Minister of Health, South Africa, World Health Assembly, May 16, 2005

10 Nature, 435, , May 12, 2005 Science, April 29, 2005, HPV vaccine Merck, GSK

11 Science, 2005, 308:

12 Science, 2005, 308:

13 Why WHO? Global, neutral, independent Convening power Role in setting norms and standards in research, policy and practice GCP, Ethics guidelines, Classification standards (ICD) Contribute to capacity building Political legitimacy, accountable to member states

14 Statement of NY Workgroup Need for global approach to clinical trials registration Unambiguous identification of trials Developing consensus on which trials, data, timing and disclosure of results One-stop, publicly available search portal Simple, effective, efficient Building capacity where appropriate WHO should establish formal process on a global approach Appropriate governance Collaborative process, involving all interested parties Leveraging existing structures; identifying any need for new structures Mindful of ICMJE deadline

15 Key issues* Registration standards-which trials to register? When? What? Trials characteristics (minimum data set) Results disclosure standards WHO Registry-Where to register? *Discussed at a WHO Technical Consultation, Geneva, April 25-27, 2005

16 Minimum data set (I) 1. Unique trial number 2. Trial registration date 3. Secondary identification 4. Funding source(s) 5. Primary sponsor 6. Secondary sponsor(s) 7. Responsible contact person 8. Research contact person 9. Title of study 10. Official scientific title of study

17 Minimum data set (II) 11. Research ethics review 12. Condition 13. Intervention(s) 14. Key inclusion & exclusion criteria 15. Study type 16. Anticipated trial start date 17. Target sample size 18. Recruitment status 19. Primary outcome 20. Key secondary outcomes

18 ICTRP Project Provide global standards for registration and disclosure of trials, including compliance Virtual global network of certified clinical trial registers Unique, unambiguous identifier State of the art global search function Build national capacity for CTR in developing countries

19 58 th World Health Assembly, Geneva, May 16-25, 2005

20 58 th WHA Resolution CALLS UPON the global scientific community, civil society, international partners, the private sector and other relevant stakeholders : "to establish a platform linking a network of international clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials"

21 "We are ready to move forward with an International Clinical Trials Registry. This will do much to strengthen the research process and its ability to win public trust" Dr J.W. Lee WHO Director-General Opening Address to the World Health Assembly May 16, 2005