1. www.tfda.or.tz 1 AVAREF MEETING - 5 20 – 24 th, September, 2010 Nairobi - Kenya Registry component: Pilot Implementation Experience in Tanzania Fimbo, A. M Tanzania Food and Drugs Authority

2. www.tfda.or.tz 2 Background ► Recommendation 5 & 6 (AVAREF 4) ► The Pilot countries; Tanzania, Uganda, Senegal, Nigeria, Mozambique, B/Faso and Gabon to agree on a set of data that will constitute the basis for national databases for CTs. ► All AVAREF member countries agreed to include registration in PACTR or when justified another WHO primary registry or data provider as a requirement for the submission of CTAs.

3. www.tfda.or.tz 3 Review of data elements ► Consultation through emails amongst AVAREF pilot countries began immediately after AVAREF 4 ► The 20 minimum data elements of the WHO ICTRP were discussed and additions recommended ► The 20 elements were finally agreed with addition of 4 more elements

4. www.tfda.or.tz 4 Data elements (1) 1. Primary Registry and Trial Identifying Number 2. Date of Registration in Primary Registry 3. Secondary Identifying Numbers 4. Source(s) of Monetary or Material Support 5. Primary Sponsor 6. Secondary Sponsor(s) 7. Contact for Public Queries 8. Contact for Scientific Queries 9. Public Title 10. Scientific Title 11. Countries of Recruitment 12. Site(s) of Recruitment (added)

5. www.tfda.or.tz 5 Data elements (2) 13. Health Condition(s) or Problem(s) Studied 14. Intervention(s) 15. Key Inclusion and Exclusion Criteria 16. Study Type 17. Date of First Enrollment 18. Target Sample Size 19. Recruitment Status 20. Primary Outcome(s) 21. Key Secondary Outcomes 22. Ethical and Regulatory approvals 23. Regulatory Inspection status (for positive outcomes) 24. Any safety alerts/concerns issued

6. www.tfda.or.tz 6

7. 7 Tanzania experience ► Gaining experience from other Registry Platforms ► Reviewing the existing legal requirements for registration of trials ► Drafting Regulations ► Creating a National Registry (database) ► Agreeing on future steps

8. www.tfda.or.tz 8 Gaining experience from other Registries (1) ► Contacted the WHO International Clinical Trials Registry Platform (ICTRP) for advise and possible support. ► Specifically asked for models that can be adopted/adapted. ► Existing databases and softwares. ► Issues related to registry requirements, access, search ability and best practices on their use.

9. www.tfda.or.tz 9 Gaining experience from other Registries (2) ► WHO connected TFDA with the National Patient Safety Agency (NPSA) of the UK ► Allowed us to access their system ► Integrated Research Application System (IRAS) (Infonetica). ► Now in regular contact with NPSA on how to customize and install the system.

10. www.tfda.or.tz 10 IRAS

11. www.tfda.or.tz 11 IRAS

12. www.tfda.or.tz 12 IRAS

13. www.tfda.or.tz 13 Gaining experience from other Registries (3) ► Accessed other registries from the WHO ICTRP website (http://www.who.int/ictrp/network/primary/en/index.html):http://www.who.int/ictrp/network/primary/en/index.html ► Australian New Zealand Clinical Trials Registry (ANZCTR) ► Clinical Trials Registry - India (CTRI) ► German Clinical Trials Register (DRKS) ► The Netherlands National Trial Register (NTR) ► South African National Clinical Trial Register (SANCTR) ► Pan African Clinical Trial Registry (PACTR) ► Sri Lanka Clinical Trials Registry (SLCTR) ► European Clinical Trials Database (EUDRACT) ► www. ISRCTN.org ► www.clinicaltrials.gov ► Accessed other registries from the WHO ICTRP website (http://www.who.int/ictrp/network/primary/en/index.html):http://www.who.int/ictrp/network/primary/en/index.html ► Australian New Zealand Clinical Trials Registry (ANZCTR) ► Clinical Trials Registry - India (CTRI) ► German Clinical Trials Register (DRKS) ► The Netherlands National Trial Register (NTR) ► South African National Clinical Trial Register (SANCTR) ► Pan African Clinical Trial Registry (PACTR) ► Sri Lanka Clinical Trials Registry (SLCTR) ► European Clinical Trials Database (EUDRACT) ► www. ISRCTN.org ► www.clinicaltrials.gov

14. www.tfda.or.tz 14 Gaining experience from other Registries (4) ► The WHO also connected TFDA with BIREME (Latin American & Caribbean Center on Health Sciences Information). ► Consultations are still ongoing to learn the functions of their register (LATINREC register). ► We also reviewed the requirements of the International Committee of Medical Journal Editors (ICMJE) as the WHO requires potential registrants to register their trials in either a Primary Registry in the WHO Registry Network or an ICMJE approved registry (http://www.icmje.org/)http://www.icmje.org/

15. www.tfda.or.tz 15 Review of the existing legislation ► The National Health Act of 2004 of South Africa ► The World Medical Association – Declaration of Helsinki ► The National Statement on Ethical Conduct in Human Research (2007), Australia ► Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Canada ► The US - Food and Drug Administration Amendments Act of 2007 (FDAAA)

16. www.tfda.or.tz 16 Drafting Regulations (1) ► Title - The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2009 ► Have defined the National Registry ► As a database created by the Authority that houses and manages information about a clinical trial submitted by an applicant ► The Regulations requires applicants to register their trials in the National Registry (Regulation 6)

17. www.tfda.or.tz 17 Draft Regulations (2) ► The clinical trial information required to be provided in the National Registry include; ► Descriptive information (Regulation 7(2) (a)) ► Recruitment information (Regulation 7(2) (b)) ► Location and contact information (Regulation 7(2) (c)) ► Administrative data (Regulation 7(2) (d))

18. www.tfda.or.tz 18 Draft Regulations (3) ► Descriptive information: ► a brief title, intended for the lay public; ► a scientific title as it appears in the protocol including trial acronym, if available ► a brief summary, intended for the lay public; ► the primary purpose; ► the study design; ► for an applicable drug clinical trial, the study phase;

19. www.tfda.or.tz 19 Draft Regulations (4) ► Descriptive information cont…: ► study type; ► primary disease or condition being studied, or the focus of the study; ► intervention name and intervention type; ► study start date; ► expected completion date; ► target number of participants; and ► outcomes, including primary and secondary outcome measures;

20. www.tfda.or.tz 20 Draft Regulations (5) ► Recruitment information: ► eligibility criteria; ► gender; ► age limits; ► whether the trial accepts healthy volunteers; ► overall recruitment status; and ► individual site status.

21. www.tfda.or.tz 21 Draft Regulations (6) ► Location and contact information: ► Name of the sponsor; ► Name of the applicant; and ► Facility name and facility contact information (including the city, phone number, fax number and email address through which such location information may be accessed).

22. www.tfda.or.tz 22 Draft Regulations (7) ► Administrative data: ► Unique protocol identification number; ► Other protocol identification numbers, if any; ► Application number assigned by the Authority; and ► Date of registration of the clinical trial in the National Registry

23. www.tfda.or.tz 23 Draft Regulations (8) ► The Custodian of the National Registry will be the TFDA ► The Custodian will ensure that the public may, in addition to keyword searching, search the entries in the National Registry by one or more of the following criteria: ► The disease or condition being studied in the clinical trial; ► The name of the intervention, including any drug or device being studied in the clinical trial; ► The location of the clinical trial; ► The age group studied in the clinical trial, including paediatric subpopulations; ► The study phase of the clinical trial; ► The Sponsor of the clinical trial; ► The recruitment status of the clinical trial; and ► The National Clinical Trial number or other study identification for the clinical trial.

24. www.tfda.or.tz 24 Draft Regulations (9) ► An applicant is required to upload data in the National Registry not later than 21 days after the first patient is enrolled in a clinical trial. (Regulation 7(6)). ► The Authority will ensure that clinical trial data is posted in the National Registry not later than 30 days after submission. (Regulation 7(7)).

25. www.tfda.or.tz 25 Draft Regulations (10) ► The Authority will: ► Ensure that such results are made publicly available; ► Post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials ► Ensure that clinical trial information posted does not mislead the patients or the public ► (Regulation 7(8)).

26. www.tfda.or.tz 26 Draft Regulations (11)

27. www.tfda.or.tz 27 Creating a National Registry ► The TFDA has approved a budget for creation of the National Registry. ► This has considered all the databases and/or other Registries accessed. ► A link will be established within the TFDA website (www.tfda.or.tz)www.tfda.or.tz ► It has been partially completed and is currently being tested internally to see how it works.

28. www.tfda.or.tz 28 Next steps ► Pre-testing the Registry. ► Sensitizing stakeholders – MoHSW, National Ethics Commitee (NEC), Sponsors, Investigators & the general public. ► Piloting with other AVAREF countries. ► Conducting training on its use. ► Getting more experience from other countries on how to operate and manage the Registry including regular updating and monitoring. ► Deciding on who should be the custodian of the Registry. ► Official launching of the Registry.