1. PRESENTATION ON CLINICAL TRIALS REGISTRY -AN INSIGHT BY: Snigdha Debnath Bioinformatics Institute of India
2. INDEX CLINICAL TRIALS REGISTRY–THE CONCEPT IMPORTANCE OF TRIAL REGISTRATION AND REPORTING INTRODUCTION TO CTRI CTRI DATASET WHO CLINICAL TRIALS REGISTRY PLATFORM ABOUT BII BII’s PROGRAMS IN CLINICAL TRIALS
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9. CTRI DATASET Intervention and Comparator agent WHO Contact Person (Public Query) WHO Key inclusion/Exclusion Criteria WHO Funding Source/s WHO Method of allocation concealment Status of Trial * Blinding and masking Method of generating randomization sequence Site/s of study Brief Summary Countries of Recruitment WHO Study Type WHO Secondary Outcome/s WHO Phase of Trial * Primary Outcome/s WHO
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11. The International Search Portal WHO CLINICAL TRIALS REGISTRY PLATFORM The Search Portal is a web site that enables users to search a central database that contains the trial registration data sets provided by Primary Registers of ICTRP such as CTRI. When a user finds a trial on the Search Portal that they are interested in, they can learn more about the trial by clicking on a link that will take them to the relevant record in the source register. The Search Portal is not a clinical trials register. Two kinds of searches can be undertaken at the International Search Portal, viz. Simple Search Advanced Search
12. WHO CLINICAL TRIALS REGISTRY PLATFORM Registry Network ICTRP accepts data into the Search Portal from registries that meet specific criteria. Within the framework of the ICTRP, these registries are referred to as Primary Registries. In addition to primary registries, the registry network has provision for Secondary or Partner Registries as well which work in close relation with any single primary registry. PRIMARY REGISTRIES NEW ZEALAND AUSTRALIA INDIA SRI LANKA ISRCTN CHINA NETHERLANDS PARTNER REGISTRIES CLINICAL TRIALS.GOV, USA EUROPEAN UNION
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15. WHO CLINICAL TRIALS REGISTRY PLATFORM Comparative Study on Primary Registries Australian New Zealand Clinical Trials Registry (ANZCTR) The ANZCTR is advised by an external Advisory Policy Committee whose role is to advise on the scope, operation, accessibility, sustainability and international obligations of the ANZCTR. It is funded by National Health and Medical Research Council of Australia; New Zealand Health Research Council and managed by NHMRC Clinical Trials Centre, University of Sydney. The register URL is http://www.anzctr.org.au . The register is managed by National Institute of Medical Statistics (NIMS) and funded by India Department of Science and Technology (DST); Indian Council of Medical Research (ICMR); World Health Organization (WHO). The register URL is http://www.ctri.in . Clinical Trials Registry - India (CTRI)
16. WHO CLINICAL TRIALS REGISTRY PLATFORM The ChiCTR Advisory and Management Board consists of experts from the Chinese Evidence-Based Medicine Centre and Chinese Cochrane Centre, Ministry of Health of China, and United Kingdom Cochrane Centre. ChiCTR is funded by West China Hospital, Sichuan University. The register URL is http://www.chictr.org . ISRCTN.org Chinese Clinical Trial Register (ChiCTR) ISRCTN is a not-for-profit organization, funded through a fee per trial paid by trial detail providers. The register is owned by ISRCTN with Directors, Members and Member Organisations such as Current Controlled Trials Ltd, which administers the scheme on behalf of ISRCTN. The register URL is http://www.isrctn.org .
17. WHO CLINICAL TRIALS REGISTRY PLATFORM The Netherlands National Trial Register (NTR) The Dutch Cochrane Centre (DCC) is the managing agency behind NTR. The organisation is funded by ZonMw Netherlands Organization for Health Research and Development (main funding agency). Additional funding is obtained from the Health Council (Gezondheidsraad); Dutch Cancer Society (KWF) and Dutch College of General Practitioners (NHG). The registry URL is http:// www.trialregister.nl . Sri Lanka Clinical Trials Registry (SLCTR) The Sri Lanka Clinical Trials Registry Committee is nominated by the Sri Lanka Medical Association which is also the chief funding agency. The registry URL is http:// www.slctr.lk
18. WHO CLINICAL TRIALS REGISTRY PLATFORM Comparison Chart on Registry Criteria of Primary Registries Yes Under development Yes, under development Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry have documented Standard Operating Procedures (SOPs)? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible registrants? Registry Criteria
19. WHO CLINICAL TRIALS REGISTRY PLATFORM Initial training of staff in the submission and query processes; conduction of regular audits; timely reviewing of SOPs Under development Under development Well trained staff; regular statistical and qualitative analysis of trial records; regular reviewing of SOPs. Information currently unavailable Information currently unavailable ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Description of the compliance mechanisms: Yes Under development Yes, under development Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Are mechanisms in place to ensure compliance with these SOPs? (e.g. staff training) Registry Criteria
20. WHO CLINICAL TRIALS REGISTRY PLATFORM Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Is the Registry open to all prospective registrants? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to participate in the development of Guidelines for Clinical Trial Registries? Registry Criteria
21. WHO CLINICAL TRIALS REGISTRY PLATFORM Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Can the Registry collect and publicly display the WHO Trial Registration Data Set (TRDS)? English English, Chinese English English English English ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Languages in which the registered information is displayed: Registry Criteria
22. WHO CLINICAL TRIALS REGISTRY PLATFORM On submission of trial for registration, its assessment by ANZCTR staff for completeness, identification of queries, if any and suggestion of changes to resolve them. Trial registered only on satisfactory completion of all data. Two step process-Initial control performed by assessor for verification of proper filling of 20-item dataset, followed by final control by final checking. Initially done by two scientists manually. To be done electronically at later stage. Mandatory provision of all 20 items at application stage, verifies that content is provided for all fields and that the content is applicable. If all the information is not provided, the trialist is contacted and the reasons why are recorded. Application of login code a must before registration of trial; checking and re-checking of contact and other details given in registration form; regular updating of information non-acceptance of incomplete submissions, except when only a few items are missed; deletion of trial lacking crucial information from register. Cross-checking of applications by Administrator before acceptance; requesting applicants to re-submit incomplete applications; holding monthly meetings regarding completeness and accuracy of applications. ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Quality control measures to make sure that all 20 items in the WHO TRDS are as complete and accurate as possible: Registry Criteria
23. WHO CLINICAL TRIALS REGISTRY PLATFORM N/A; Trials with incomplete WHO TRDs are not accepted for registration Yes Yes No Information currently unavailable Information currently unavailable ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to submit the WHO Trial Registration Data Set, in English, to the Central Repository? Registry Criteria
24. WHO CLINICAL TRIALS REGISTRY PLATFORM Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to keep registered information up-to-date? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to never to remove a trial once it has been registered? Registry Criteria
25. WHO CLINICAL TRIALS REGISTRY PLATFORM Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry publicly disclose ownership, governance structure and not/for-profit status? http://www.anzctr.org.au . http://www.chictr.org http://www.ctri.in http://www.controlled-trials.com/isrctn http://www.trialregister.nl http:// www.slctr.lk/faq.asp ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR The web address where this information is displayed: Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Does the Registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a Collaborating Registry in the Registry Network? Registry Criteria
26. WHO CLINICAL TRIALS REGISTRY PLATFORM Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR From which countries will the Registry accept trials for registration? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Is the Registry searchable over the Internet at no charge? Yes Yes Yes Yes Yes Yes ANZCTR ChiCTR CTRI ISRCTN NTR SLCTR Is the Registry open to all prospective registrants?
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29. WHO CLINICAL TRIALS REGISTRY PLATFORM Date of 1st enrolment* Target sample size* Phase Study type* Name of the study group Public title* Health Conditions studied* Full scientific study title* Secondary IDs* Date of registration* ELN-Study Number* Unique Trial Number* Interventions* Exclusion Criteria* Inclusion Criteria* Countries of recruitment* Contact for scientific queries* Contact for public queries* Contact person (s) in Study Center Aims Recruitment status* Age Stage
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35. BII’s PROGRAMS IN CLINICAL TRIALS The prime objective of this program is to help to understand basics of clinical trials. It has been specifically designed to answer scientific questions and to find better ways to treat individuals with a specific disease. The core areas of studies are comprised as follows: ONLINE PROGRAM IN CLINICAL TRIALS & RESEARCH (3 MONTHS e-LEARNING PROGRAM) Teaching and learning methods include content documents, directed reading, a range of on-line systems of information retrieval, literature reviews and moderated on-line seminars. Graduates in any discipline can apply . Highly motivated students pursuing graduation /Diplomas courses in Pharmaceutical science/chemistry and allied areas are also eligible . Course fee is INR 5000. Bioethics Clinical Trial Regulatory Affairs Clinical Trial Business Environment Clinical Trial Delivery Model Clinical Trial Team Clinical Trial Informatics Design of Experiments Bioavailability Studies Clinical Trial Statistics Patient Recruitment Good Clinical Trial Practices Features of Clinical Trials Basics of Clinical Trials & Clinical Research
36. THANK YOU For Further Details & Enquiries, Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: [email_address] Visit: www.bii.in
