Transcript Clinical Trials Registry - Tanzania Food and Drugs Authority

AVAREF MEETING - 5
20 – 24th, September, 2010
Nairobi - Kenya
Registry component:
Pilot Implementation Experience
in Tanzania
Fimbo, A. M
Tanzania Food and Drugs Authority
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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.
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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
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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)
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Data elements (2)
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23.
Health Condition(s) or Problem(s) Studied
Intervention(s)
Key Inclusion and Exclusion Criteria
Study Type
Date of First Enrollment
Target Sample Size
Recruitment Status
Primary Outcome(s)
Key Secondary Outcomes
Ethical and Regulatory approvals
Regulatory Inspection status (for positive
outcomes)
24. Any safety alerts/concerns issued
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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
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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.
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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.
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IRAS
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IRAS
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IRAS
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Gaining experience from other
Registries (3)
► Accessed other registries from the WHO ICTRP website
(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)
(PACTR)
► Sri Lanka Clinical Trials Registry (SLCTR)
► European Clinical Trials Database (EUDRACT)
► www. ISRCTN.org
► www.clinicaltrials.gov
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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/)
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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)
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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)
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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))
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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;
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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;
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Draft Regulations (5)
►Recruitment information:
►eligibility criteria;
►gender;
►age limits;
►whether the trial accepts healthy volunteers;
►overall recruitment status; and
►individual site status.
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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).
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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
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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.
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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)).
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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)).
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Draft Regulations (11)
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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)
►It has been partially completed and is
currently being tested internally to see how
it works.
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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.
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