Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz BRAZILIAN CLINICAL TRIALS REGISTRY - REBRAC 5th Clinical Data Disclosure Summit Washington DC, January 12th 2010

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz NATIONAL CT REGISTER th Brazilian Congress on Collective Health & 11 th World Public Health Congress: 2 alternatives – regional network of national registries or creation of independent primary registries 2008 Ministerial directives MS/GM n° 1345 e 2448: created a Commission to elaborate the Implementation Project of REBRAC – Brazilian primary register with a flexible, open source web platform for Latin America and the Caribbean 2009 Technical and Consultant Committees with participants from Ministry of Health, ANVISA, BIREME, PAHO and FIOCRUZ. PAHO, MoH and FIOCRUZ are funding the web platform development; FIOCRUZ will implement and run the REBRAC

Ministério da Saúde FIOCRUZ Fundação Oswaldo CruzOBJECTIVES Estabilish a broad and up to date registry of interventional and observational studies from Brazil, Latin America & Caribbean Provide access to interested stakeholders of ongoing or completed studies - reliable and free of charge data for reviews/metanalyses, guidelines, research policy Increase transparency in research, strenghening the ethical and scientific value of interventional and observational studies Facilitate the discovery and control of design, publication bias and reduce language bias Integrate into ethic and regulatory processes Attend national and regional information needs

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz STUDIES TO BE REGISTERED “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes” (ICTRP e ICMJE) Interventional studies: clinical trials phase I to IV Obervational studies: neglected diseases

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz DATA FIELDS Trial identifying number Date of registration: date after revision/approval Secundary identifying numbers – id & issuing authority Sources of monetary or material support Principal sponsor: institution data, type (university, agency, government, other) Secondary sponsors Contact for public queries Contact for scientific queries Public title Scientific title Countries of recruitment: ISO alpha-2 code

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz DATA FIELDS Health condition(s) or problem(s) studied: IDC-10, DeCs/MeSH – 4 fields (free text, code, description, source) Intervention(s): free text, code, description, source, type (PB) Key inclusion and exclusion citeria: age (min/max), sex, healthy volunteers? + free text for inclusion/exclusion Study type: free text, fields (PB) Date of first enrollment Completion date: anticipated and actual Target sample size Recruitment status: controlled vocabulary Primary and secondary outcomes

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz ADDITIONAL DATA It´s expected, but not mandatory, from registrants to append study protocols, addends and results - description or links to reports, communications and/or published articles.

Ministério da Saúde FIOCRUZ Fundação Oswaldo CruzREGISTRANT Data for registration will be provided by the sponsor, contract research organization, principal investigator or other designated representative (in accordance to resolution RDC 39 – ANVISA). National and international multicentric studies must be registered only once by the sponsor or delegated representative, including data of responsible researcher for every site of the study (in accordance to the CNS directive nº /13/05). No charge for registration and free access

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz WHEN REGISTER After approval of the Ethics Committee from the institution hosting the study and/or from the National Research Ethical Committee (CONEP) and before recruitment of first participant Integration with CONEP information system (Plataforma BRASIL) will allow the pre-registration at REBRAC, after agreement of the registrant – minimize extra work for applicants Three types of users: administrative/reviewer trialist - submit and update register data public – search registries The trialist, in his first submission to REBRAC, will apply for an account and login/password.

Ministério da Saúde FIOCRUZ Fundação Oswaldo CruzFUNCTIONALITIES List of possible duplicities Detection of outdated records History of updates – audit trails Search: basic and advanced Inclusion of additional fields Import and export data in XML

Ministério da Saúde FIOCRUZ Fundação Oswaldo CruzCHALLENGES Quality Assurance – review in three languages Taxonomies Political sustainability: support from scientific journals, research institutions, funding organizations. Legal enforcement: RDC 39/ “For therapy studies (Phase III) present proof of the clinical trial is listed in the database for registration of clinical trials ICTRP / WHO or other recognized by International Commit of Medical Journals Editors (ICMJE)” – monetary penalty Number of register/year: minimum of 200 studies approved by ANVISA

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz ON LINE WORKING ENVIRONMENT FLOSS (Free Libre Open Source Software)

Ministério da Saúde FIOCRUZ Fundação Oswaldo Cruz THANK YOU!