registration of clinical trials: background and implementation ida sim, md, phd project coordinator...

Registration of Clinical Trials:Registration of Clinical Trials:Background and ImplementationBackground and Implementation

Ida Sim, MD, PhDIda Sim, MD, PhD

Project CoordinatorProject Coordinator

Department of Research Policy and CooperationDepartment of Research Policy and Cooperation

World Health OrganizationWorld Health Organization

Geneva, Switzerland;Geneva, Switzerland;

and University of California San Francisco, USAand University of California San Francisco, USA

August 22, 2006August 22, 2006

Ida Sim, WHO, 2006

OutlineOutline

BackgroundBackground Why register trials?Why register trials?

Why WHO project?Why WHO project?

WHO International Clinical Trials Registry PlatformWHO International Clinical Trials Registry Platform

Intellectual Property ConcernsIntellectual Property Concerns

Current WorkCurrent Work

SummarySummary

Ida Sim, WHO, 2006

Clinical TrialsClinical Trials

Everyone wants to do evidence-based medicineEveryone wants to do evidence-based medicine health care delivery based on best available health care delivery based on best available

evidenceevidence

Clinical trials one of the most valuable sources of Clinical trials one of the most valuable sources of evidence about evidence about

whether a health treatments workswhether a health treatments works whether it is safewhether it is safe

Billions of dollars spent worldwide every year on Billions of dollars spent worldwide every year on clinical trialsclinical trials

Critical that public trusts clinical trial resultsCritical that public trusts clinical trial results

Ida Sim, WHO, 2006

Can We Trust Clinical Trials?Can We Trust Clinical Trials?

““Publication bias”: negative results often not published Publication bias”: negative results often not published small, negative studies least likely to be publishedsmall, negative studies least likely to be published negative studies often not submitted to journalsnegative studies often not submitted to journals only ~40% of meeting abstracts published only ~40% of meeting abstracts published (Scherer, 94)(Scherer, 94)

of trials submitted to FDA in support of drugs that of trials submitted to FDA in support of drugs that were eventually approved were eventually approved (Sim, in prep)(Sim, in prep)

only 42% published in 3.7 years after drug approved only 42% published in 3.7 years after drug approved negative trials less likely to be publishednegative trials less likely to be published

Publication bias can mislead clinical practicePublication bias can mislead clinical practice combination chemo for ovarian cancer combination chemo for ovarian cancer (Simes, 86)(Simes, 86)

p = 0.02 in published trialsp = 0.02 in published trials p = 0.25 in all registered trialsp = 0.25 in all registered trials

Ida Sim, WHO, 2006

Can We Trust Clinical Trials? (cont.)Can We Trust Clinical Trials? (cont.)

CLASS trial published in JAMA, 2001CLASS trial published in JAMA, 2001 6 month data showed celecoxib caused fewer 6 month data showed celecoxib caused fewer

symptomatic ulcers and ulcer complications symptomatic ulcers and ulcer complications than did diclofenac or ibuprofenthan did diclofenac or ibuprofen

but trial protocol included 12 month timepoint, but trial protocol included 12 month timepoint, which did not show any differenceswhich did not show any differences

Outcomes reporting bias Outcomes reporting bias (Chan, 2004)(Chan, 2004)

comparing ethics board protocols to comparing ethics board protocols to publications, 50% of efficacy outcomes not publications, 50% of efficacy outcomes not reportedreported

positive outcomes more likely to be reported positive outcomes more likely to be reported (O.R. 2.4, 95% c.i. 1.4-4.0)(O.R. 2.4, 95% c.i. 1.4-4.0)

Ida Sim, WHO, 2006

What to Do?What to Do?

Problem generally known for over 30 yearsProblem generally known for over 30 years

Solution is to Solution is to registerregister all trials before they all trials before they startstart

collect key scientific parameters (e.g., collect key scientific parameters (e.g., outcomes and timepoints) outcomes and timepoints)

allows tracking of trials to ensure that all allows tracking of trials to ensure that all trials and all results are publishedtrials and all results are published

But nothing happened until...But nothing happened until...

Ida Sim, WHO, 2006

Extensive Media CoverageExtensive Media Coverage

Aug 2004Aug 2004 GSK settles US$20 million suit for fraud in not GSK settles US$20 million suit for fraud in not

reporting negative paroxetine resultsreporting negative paroxetine results

Sept 2004Sept 2004 Merck pulled rofecoxib off the market amid Merck pulled rofecoxib off the market amid

continuing concerns that data was hidden from continuing concerns that data was hidden from publicpublic

estimated tens of thousands of heart attacks estimated tens of thousands of heart attacks happened unnecessarilyhappened unnecessarily

Ida Sim, WHO, 2006

Need for Trial RegistrationNeed for Trial Registration

Public needs and deserves a full and unbiased Public needs and deserves a full and unbiased public record on safety and effectivenesspublic record on safety and effectiveness

Trial registration is necessary to ensure full Trial registration is necessary to ensure full reporting of trial resultsreporting of trial results

Global need to restore public trust in clinical Global need to restore public trust in clinical trials, avoid drop in participant enrollmenttrials, avoid drop in participant enrollment

Ida Sim, WHO, 2006

OutlineOutline






SummarySummary

Ida Sim, WHO, 2006

Current PoliciesCurrent Policies

As of September 2005, International Committee As of September 2005, International Committee of Medical Journal Editors (ICMJE) journals accept of Medical Journal Editors (ICMJE) journals accept only registered trials for potential publicationonly registered trials for potential publication

many other journals have followed this policymany other journals have followed this policy

Many trial registration laws and policies being Many trial registration laws and policies being proposed worldwideproposed worldwide

e.g., ~50 laws proposed or adopted in US states e.g., ~50 laws proposed or adopted in US states and Congressand Congress

Overlapping and conflicting laws will make multi-Overlapping and conflicting laws will make multi-country trials difficultcountry trials difficult

Ida Sim, WHO, 2006

Many Registers WorldwideMany Registers Worldwide

Probably around 1000 registers exist worldwideProbably around 1000 registers exist worldwide

Registers vary in their Registers vary in their scope: e.g., country, disease, funderscope: e.g., country, disease, funder

many new country registers (many new country registers (India, China, South Africa, India, China, South Africa, Germany, Iran, etc.)Germany, Iran, etc.)

purpose: e.g., participant enrollment, administrative purpose: e.g., participant enrollment, administrative tracking, scientific analysis tracking, scientific analysis

Need for global standardization, coordination, and cooperationNeed for global standardization, coordination, and cooperation

Ida Sim, WHO, 2006

Why World Health Organization?Why World Health Organization?

Global, neutral, independent body with convening Global, neutral, independent body with convening capacity capacity (i.e. World Health Assembly resolutions)(i.e. World Health Assembly resolutions)

Authoritative; Role in setting norms and Authoritative; Role in setting norms and standards in research, standards in research, policy and practicepolicy and practice

Good Clinical Practice, Ethics guidelines, Good Clinical Practice, Ethics guidelines, Classification standards Classification standards (e.g., ICD)(e.g., ICD)

Contributes to capacity building Contributes to capacity building (i.e. in developing countries)(i.e. in developing countries)

Political legitimacy, accountable to 192 member Political legitimacy, accountable to 192 member StatesStates

Commitment to achieving equity in healthCommitment to achieving equity in health

Ida Sim, WHO, 2006

Leading up to WHO Registry PlatformLeading up to WHO Registry Platform

Oct 2003Oct 2003

WHO Director-General highlighted trial WHO Director-General highlighted trial registration in global health researchregistration in global health research

Oct 2004Oct 2004 –Rockefeller Foundation meeting, NY –Rockefeller Foundation meeting, NY

Need for global approach to trial registrationNeed for global approach to trial registration

WHO should establish formal process on a global WHO should establish formal process on a global approachapproach

Ida Sim, WHO, 2006

Leading up to Leading up to WHO Registry PlatformWHO Registry Platform

Nov 2004Nov 2004 – Ministerial Summit on Health Research, – Ministerial Summit on Health Research, Mexico CityMexico City

Ministers of Health and others from 52 countries called on WHO to • establish network of clinical trial registers • ensure unambiguous identification of trials• ensure a single point of access

April 2005April 2005 – Technical Consultation, Geneva – Technical Consultation, Geneva Meeting of diverse stakeholders to build consensus Meeting of diverse stakeholders to build consensus

policiespolicies

May 2005May 2005 – 58 – 58th th World Health AssemblyWorld Health Assembly

Ida Sim, WHO, 2006

"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"

"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. Leepast WHO Director-General

Opening Address to World Health Opening Address to World Health Assembly, May 2005Assembly, May 2005

Ida Sim, WHO, 2006

WHO Registry PlatformWHO Registry Platform Registry Platform project is now a global leader in trial Registry Platform project is now a global leader in trial registrationregistration

havehave received support and participation from all relevant stakeholder groups

Accomplishments to date defined 20 item WHO Trial Registration Data Set

called for full disclosure of registration data at time of registration (no “lockbox”)

outlined a coordinated global platform for trial registration

But much more needs to be done to make trial registration a widespread and routine reality

Ida Sim, WHO, 2006

OutlineOutline






SummarySummary

Ida Sim, WHO, 2006

Goal and Goal and ObjectivesObjectives

Goal strengthen public trust in clinical research by promoting

transparency and accountability

Objectives ensure that all interventional trials worldwide are

registered and thus publicly declared and identifiable ensure that a minimum set of results are publicly reported

for all registered trials develop compliance mechanisms to ensure that all parties

follow the same rules support use of trial registration information for recruitment,

research planning, etc.

Ida Sim, WHO, 2006

Registry Platform Registry Platform Administrative StructureAdministrative Structure

International Advisory Board

broad-based, 15 senior leaders

advise on strategy/direction

lead in communication/ advocacy

Scientific Advisory Group 21 experts advise on principles/

substantive standards working groups

trial registers results reporting

Registry Platform

Secretariat

WHO EIP/RPC

Scientific Advisory Group

InternationalAdvisory Board

Ida Sim, WHO, 2006

FundingFunding

Internal SupportInternal Support

WHO start-up and operational fundsWHO start-up and operational funds

External SupportExternal Support

English Department of HealthEnglish Department of Health Japanese Ministry of HealthJapanese Ministry of Health Wellcome TrustWellcome Trust Canadian Institutes of Health ResearchCanadian Institutes of Health Research

In-kind support from experts and stakeholdersIn-kind support from experts and stakeholders

Travel, meetings, consultationsTravel, meetings, consultations

Ida Sim, WHO, 2006

Registry PlatformRegistry Platform Overview Overview

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ResultsDatabases

WHO Search Portal

RegistriesISRCTNct.gov . . .country specific

Ida Sim, WHO, 2006

Which Trials Must RegisterWhich Trials Must RegisterThe registration of all interventional trials is a scientific, The registration of all interventional trials is a scientific, ethical, and moral responsibilityethical, and moral responsibility

Any research studyAny research study that prospectively assigns humans that prospectively assigns humans or or groups of humans to one or more health related groups of humans to one or more health related interventions to evaluate the effects on health outcomes interventions to evaluate the effects on health outcomes IncludesIncludes

all health interventions (e.g., drugs, devices, cells and all health interventions (e.g., drugs, devices, cells and biological products, procedures, behavioral treatments, biological products, procedures, behavioral treatments, care process changes, etc) care process changes, etc)

early and late phase studiesearly and late phase studies

studies on healthy volunteersstudies on healthy volunteers

marketed and not-yet-approved products and indicationsmarketed and not-yet-approved products and indications

randomized and non-randomized, etc.randomized and non-randomized, etc.

Responsible Registrant

GlobalDeduplication

WHO Search Database

WHO Central Reference Database

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WHO Registration Data Set4

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MeSH Coding

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UTRN, MeSH Codes

Associate Registers

Primary Registers

Other Registers

Search Portal

Ida Sim, WHO, 2006

Responsible RegistrantResponsible RegistrantEither the principal investigator (PI) or the primary sponsor, to be decided between them

primary sponsor is “the individual, organization, group or other legal person taking on responsibility for securing the arrangements to initiate and/or manage a study”

primary sponsor is ultimately responsible for ensuring that the trial is properly registered

for multi-centre and multi-sponsor trials, lead PI or lead sponsor is responsible registrant

Should make every reasonable effort to ensure that a trial is registered

only once in any register

registered in the fewest number of registers necessary to meet relevent regulations


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Other Registers

Search Portal

Ida Sim, WHO, 2006

Register Network StructureRegister Network Structure

Two-tiered systemTwo-tiered system Primary Registers (relatively few)Primary Registers (relatively few)

should be national, regional, or international should be national, regional, or international maximum of one per countrymaximum of one per country

submit Registration Data Set directly to WHOsubmit Registration Data Set directly to WHO

Associate Registers (relatively many) Associate Registers (relatively many) serve diverse constituents and objectives serve diverse constituents and objectives must be affiliated with a Primary Registermust be affiliated with a Primary Register

submit Registration Data Set to that registersubmit Registration Data Set to that register

Ida Sim, WHO, 2006

Draft Primary Register CriteriaDraft Primary Register Criteria

Main requirementsMain requirements perform quality assurance and local deduplicationperform quality assurance and local deduplication use Registry Platform data interchange standard use Registry Platform data interchange standard entries can be in any language, but uploads to WHO entries can be in any language, but uploads to WHO

must be in Englishmust be in English open access (free public access to all entries) open access (free public access to all entries)

Encouraged but not required toEncouraged but not required to

Collect or store protocol document itselfCollect or store protocol document itself Collect or store protocol amendmentsCollect or store protocol amendments Store or link to trial resultsStore or link to trial results

Should charge no or only minimal registration fees Should charge no or only minimal registration fees

Ida Sim, WHO, 2006

Registers and Registers and Global Regulatory CapacityGlobal Regulatory Capacity

Want the fewest number of registers necessary to Want the fewest number of registers necessary to serve global needsserve global needs

easier to identify duplicates and assign UTRNeasier to identify duplicates and assign UTRN WHO working with countries to coordinate regional WHO working with countries to coordinate regional approaches to trial registrationapproaches to trial registration

Latin America leading in establishing a regional Latin America leading in establishing a regional approachapproach

Trial registers may be focal points for developing Trial registers may be focal points for developing clinical trial regulatory capacityclinical trial regulatory capacity

national and regional registers listing ongoing trials national and regional registers listing ongoing trials

link to ethics review mechanisms, GCP, etc.link to ethics review mechanisms, GCP, etc.


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MeSH Coding

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Associate Registers

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Search Portal

Ida Sim, WHO, 2006

WHO Registration Data Set (1)WHO Registration Data Set (1)

1.1. Primary Register and Trial ID# (e.g., NCT)Primary Register and Trial ID# (e.g., NCT)

2.2. Date of Registration in Primary RegisterDate of Registration in Primary Register

3.3. Secondary ID#sSecondary ID#s

4.4. Source(s) of Monetary or Material SupportSource(s) of Monetary or Material Support

5.5. Primary SponsorPrimary Sponsor

6.6. Secondary Sponsor(s)Secondary Sponsor(s)

7.7. Contact for Public QueriesContact for Public Queries

8.8. Contact for Scientific QueriesContact for Scientific Queries

9.9. Public TitlePublic Title

10.10. Scientific TitleScientific Title

Ida Sim, WHO, 2006

WHO Registration Data Set (2)WHO Registration Data Set (2)

11.11. Countries of RecruitmentCountries of Recruitment

12.12. Health Condition(s) or Problem(s) StudiedHealth Condition(s) or Problem(s) Studied

13.13. Intervention(s)Intervention(s)

14.14. Key Inclusion & Exclusion CriteriaKey Inclusion & Exclusion Criteria

15.15. Study TypeStudy Type

16.16. Date of First EnrollmentDate of First Enrollment

17.17. Target Sample SizeTarget Sample Size

18.18. Recruitment StatusRecruitment Status

19.19. Primary Outcome(s)Primary Outcome(s)

20.20. Key Secondary Outcome(s)Key Secondary Outcome(s)


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Search Portal

Ida Sim, WHO, 2006

Local and Global DeduplicationLocal and Global Deduplication

Trials may be registered in more than one register (e.g., to meet laws, to increase enrollment)

Registering a trial several times can make it look like there is more research going on than there really is

Need to deduplicate trial registrations Local deduplication

individual registers should identify duplicate entries within their own register

Global deduplication WHO will coordinate the identification of duplicates

across registers worldwide

Ida Sim, WHO, 2006

Universal Trial Reference Number Universal Trial Reference Number (UTRN)(UTRN)New number to be issued by WHO to each trial deemed New number to be issued by WHO to each trial deemed unique across registersunique across registers

unique trial: conducted according to a single document (the protocol) that describes the trial’s objective(s), design, methods, statistical considerations, and organization

multi-center trial: conducted according to a single protocol but carried out at more than one site

UTRN will cross-reference entries for same trial across UTRN will cross-reference entries for same trial across multiple registersmultiple registers

each single, unique trial will have one UTRNeach single, unique trial will have one UTRN each UTRN will relate to a single unique trial worldwideeach UTRN will relate to a single unique trial worldwide no current trial ID number performs this functionno current trial ID number performs this function promotes integrity of entire systempromotes integrity of entire system


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Search Portal

Ida Sim, WHO, 2006

Search Portal and Interchange Search Portal and Interchange StandardsStandards

Search Portal will search all Primary RegistersSearch Portal will search all Primary Registers provides gateway to trial information worldwideprovides gateway to trial information worldwide wwill have patient and scientist versionsill have patient and scientist versions

Data interchange standard in early testing phaseData interchange standard in early testing phase an XML standard for Registration Data Set an XML standard for Registration Data Set

interchangeinterchange developed with CDISC, industry clinical trial data developed with CDISC, industry clinical trial data

standardsstandards associationassociation

Ida Sim, WHO, 2006

Registry PlatformRegistry Platform Overview Overview

RegistersISRCTNCT.gov . . .country specific

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OutlineOutline






SummarySummary

Ida Sim, WHO, 2006

““Intelletual Property” ConcernsIntelletual Property” Concerns

Key scientific features of trials intervention, outcomes, condition, and sample size

Revealing this information publicly at start of enrollment may allow competitors unfair advantage

a competitive advantage issue

To protect competitive advantage, pharma industry (IFPMA, PhRMA) proposed

storing registration data privately with 3rd party data to revealed to the public

only for products that receive marketing approval

within 1 year of product approval in any country if safety concerns, at discretion of company

Ida Sim, WHO, 2006

Issue is Timing of DisclosureIssue is Timing of Disclosure

Issue was not Issue was not whetherwhether to register, but when should to register, but when should data be made publicdata be made public

Question was:Question was: does public disclosure of all 20 items (including key does public disclosure of all 20 items (including key

scientific datafields) give away competitive scientific datafields) give away competitive advantage?advantage?

does degree of loss of competitive advantage justify does degree of loss of competitive advantage justify keeping data hidden from the public?keeping data hidden from the public?

Many groups strongly against industry proposalMany groups strongly against industry proposal

Had to resolve this issue to move trial registration Had to resolve this issue to move trial registration alongalong

Ida Sim, WHO, 2006

Resolving Disclosure TimingResolving Disclosure Timing

Fall and Winter 2005:Open Comment Periods

web submissions from community on key topics

April 2006:April 2006: “Safe harbor” discussion session, Geneva “Safe harbor” discussion session, Geneva

high level consultation involving strategic thinkers, key players from all stakeholder groups patients and consumers scientists and clinicians industry (pharma, devices, biotech) medical journal editors ethicists, trade law experts, others

discussed balance of transparency vs. protection of competitive advantage

Ida Sim, WHO, 2006

Summary of Disclosure TimingSummary of Disclosure Timing

Public trust greatest if all 20 items made public Public trust greatest if all 20 items made public before first participant enrolledbefore first participant enrolledFull and immediate disclosure not a big threat to Full and immediate disclosure not a big threat to competitive advantagecompetitive advantage

big differences among companies in what they reveal big differences among companies in what they reveal and when and when why can one company reveal all outcomes why can one company reveal all outcomes

immediately and another none?immediately and another none?

““intellectual property” information can often be intellectual property” information can often be bought from “industry intelligence” sourcesbought from “industry intelligence” sources

no convincing evidence that disclosure would harm no convincing evidence that disclosure would harm competition or innovationcompetition or innovation may even promote innovationmay even promote innovation

Ida Sim, WHO, 2006

WHO Disclosure Timing PolicyWHO Disclosure Timing Policy

The benefits of full and immediate disclosure The benefits of full and immediate disclosure are greater than any potential loss of are greater than any potential loss of competitive advantagecompetitive advantage

WHO calls for full disclosure of all WHO calls for full disclosure of all registration items at time of registration and registration items at time of registration and before recruitment of the first participantbefore recruitment of the first participant

Sim et al, Lancet, 2006; 367:1631-3Sim et al, Lancet, 2006; 367:1631-3

Ida Sim, WHO, 2006

OutlineOutline

BackgroundBackground

Objectives, Governance, and StructureObjectives, Governance, and Structure

WHO Registry Platform OverviewWHO Registry Platform Overview



SummarySummary

Ida Sim, WHO, 2006

Registers NetworkRegisters Network

Want the fewest number of registers necessary to Want the fewest number of registers necessary to serve global needsserve global needs

easier to identify duplicates and assign UTRNeasier to identify duplicates and assign UTRN but countries have different needs (e.g., language, but countries have different needs (e.g., language,

research planning, research oversight)research planning, research oversight)

Current prioritiesCurrent priorities establishing a coordinated regional and international establishing a coordinated regional and international

approach to trial registrationapproach to trial registration

PAHO/WHO supports Latin American countries, BIREME, PAHO/WHO supports Latin American countries, BIREME, and others in plans for a Technical Committee and others in plans for a Technical Committee

setting, meeting, and monitoring quality, setting, meeting, and monitoring quality, deduplication, and accountability standardsdeduplication, and accountability standards

Ida Sim, WHO, 2006

Results ReportingResults Reporting

Standards currently in developmentStandards currently in development

required content being defined

must link to trial registration data set, must not have must link to trial registration data set, must not have Discussion or Conclusion sectionsDiscussion or Conclusion sections

when to report: within 1 year of study completionwhen to report: within 1 year of study completion

format: electronic, web-accessible, preferably Englishformat: electronic, web-accessible, preferably English

availability: open access (all entries free to public)availability: open access (all entries free to public)

venues: journals, repositories, databases, etc. venues: journals, repositories, databases, etc.

peer review not requiredpeer review not required

should be linked to trial registersshould be linked to trial registers

Ida Sim, WHO, 2006

Ensuring a Fair SystemEnsuring a Fair System

Everyone should be held to the same rulesEveryone should be held to the same rules assures registrants that they will not be at a assures registrants that they will not be at a

disadvantage compared to those who do not disadvantage compared to those who do not registerregister

Promoting and rewarding compliancePromoting and rewarding compliance

ICMJE policyICMJE policy

requirements by funding agencies (eg CIHR)? requirements by funding agencies (eg CIHR)? universities? countries? regulatory agencies? universities? countries? regulatory agencies?

linking to ethics review? linking to ethics review?

international laws/treaties? international laws/treaties?

Ida Sim, WHO, 2006

ResearchResearch

Need for better evidence to guide registration and reporting policies

Research topics under consideration registration compliance rates

extent of and nature of duplicate registration

consequences of duplicate registration

patterns of mis-reporting and consequences

evidence supporting various recommendations for trial reporting

Ida Sim, WHO, 2006

OutlineOutline

BackgroundBackground

Objectives, Governance, and StructureObjectives, Governance, and Structure

WHO Registry Platform OverviewWHO Registry Platform Overview



SummarySummary

Ida Sim, WHO, 2006

WHO Registry Platform…WHO Registry Platform…

Has finalized required registration itemsHas finalized required registration items

Is establishing a network of Primary and Associate Is establishing a network of Primary and Associate registers to coordinate registration worldwideregisters to coordinate registration worldwide

Will perform global deduplication of trials and issue Will perform global deduplication of trials and issue UTRNs to globally unique trialsUTRNs to globally unique trials

Will launch one-stop search portal of Primary Will launch one-stop search portal of Primary RegistersRegisters

Is dIs defining standards for minimum reporting of resultsefining standards for minimum reporting of results

Is pursuing compliance mechanisms for registration Is pursuing compliance mechanisms for registration and reportingand reporting

Ida Sim, WHO, 2006

Value Added of Registry PlatformValue Added of Registry PlatformWHO is only neutral body well-placed to define standardsWHO is only neutral body well-placed to define standards

Registration Data Set (and disclosure timing policy)Registration Data Set (and disclosure timing policy) results reportingresults reporting compliance enforcementcompliance enforcement

Single international network of high-quality registersSingle international network of high-quality registers simplifies, coordinates where to registersimplifies, coordinates where to register global accountability, sharing of best practicesglobal accountability, sharing of best practices

Duplication checking and unique trial identification (UTRN)Duplication checking and unique trial identification (UTRN) enhances global integrity and information quality enhances global integrity and information quality

One-stop search portal of registers worldwideOne-stop search portal of registers worldwide ””public face," transparency, restore trust/confidence public face," transparency, restore trust/confidence

Ida Sim, WHO, 2006

Conclusion Conclusion

Clinical trials transparency and public trust is a Clinical trials transparency and public trust is a global issueglobal issue

WHO taking lead on policy and technical WHO taking lead on policy and technical platform for coordinated trial registration and platform for coordinated trial registration and reporting worldwidereporting worldwide

Overriding principle is to promote scientific and Overriding principle is to promote scientific and ethical integrityethical integrity

Input from all stakeholders welcomeInput from all stakeholders welcome

Ida Sim, WHO, 2006

WHO Registry Platform TeamWHO Registry Platform Team Project CoordinatorProject Coordinator

Ida SimIda Sim

StaffStaff Esther AwitEsther Awit An-Wen ChanAn-Wen Chan Ghassan KaramGhassan Karam Patrick UnterlerchnerPatrick Unterlerchner

Other WHO Other WHO Metin GMetin Gülmezoglu lmezoglu Tikki PangTikki Pang Luis Gabriel Cuervo (PAHO)Luis Gabriel Cuervo (PAHO)

Ida Sim, WHO, 2006

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registration of clinical trials: background and implementation ida sim, md, phd project coordinator...

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