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Session 2 Expanded Clinical Trials Registry Deborah A. Zarin, M.D. NLM Accomplishments Impact to Date Specific Data Element Issues. Pilot Quality Control Project Recommendation to Secretary – Narrative Summaries. Expanded Clinical Trial Registry. REGISTRY. New Administration

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Session 2 expanded clinical trials registry deborah a zarin m d

Session 2Expanded Clinical Trials RegistryDeborah A. Zarin, M.D.

NLM Accomplishments

Impact to Date

Specific Data Element Issues


Expanded Clinical Trial Registry

REGISTRY

New Administration

Transition Phase

Public Meeting

9/27/07

12/26/07

9/27/08

3/27/09

9/27/10

90 d

1 yr

18 m

2 yr

3 yr

Enactment

Expansion by Rulemaking: Final Rule

Additional Adverse Events Data

RESULTS

Launch Basic Results Database

Linking to existing results information at FDA and NIH


Accomplishments to date
Accomplishments To Date

  • ClinicalTrials.gov registration system (PRS) modified to enable compliance with expanded registration requirements (11/27/07)

  • Links established from registry to NIH/NLM and FDA results information

  • Information developed for affected communities

    • NLM Data Element Definitions and Fact Sheet

    • NIH Guide Notices (2) and FAQs – including instructions for initial NIH grantee/contractor compliance


Enforceability of data elements
Enforceability of Data Elements

  • Need to collect information not explicitly listed in the law

    • More detail required than specified in law (e.g., “study design”)

    • Additional information necessary to comply with law (e.g, data required to implement search requirements)

  • Competing concerns

    • Congressional intent to establish registry quickly

    • Difficulty of enforcing all necessary data elements without regulation

  • HHS is considering rulemaking


  • Revisions to registry
    Revisions to Registry

    • “Data providers” are alerted to items that (may be) required by the FDAAA

    • Omission of these items does not block acceptance of the record, and an NCT # is assigned

    • Items in question include those with some complexity, those that are required to implement the law, and one that reflects NIH policy

    • HHS is considering rulemaking



    New Records:

    2007 vs. 2006

    ~45%

    New Accounts:

    2007vs. 2006

    Sept

    Oct

    Nov

    Dec


    Enhanced registry activity 12 1 07 1 20 08
    Enhanced Registry Activity (12/1/07-1/20/08)

    • NewStudy Submissions: 2,932

      • 419 records/week

    • UpdatedStudies: 10,558

      • 1,508 records/week

    • Overall Studies: 13,490

      • 1,927 records/week; 100% increase

    • New PRS Accounts: 252

      • 36/week; 64% increase

    • Current Backlog: ~600 records (~10 days)


    Overall characteristics new studies 12 1 07 1 20 08
    Overall Characteristics: New Studies (12/1/07-1/20/08)

    Total 2,932 (100%)

    Type of Trial*

    Observational 628 (22%)

    Interventional 2,281 (78%)

    - Drug, Biologic 1,492

    - Behavioral, Gene

    Transfer, Other 479

    - Medical Procedure 290

    - Device 227

    (+27 delayed posting)

    * 23 records missing “Study Types” information


    Overall characteristics new studies 12 1 07 1 20 081
    Overall Characteristics: New Studies (12/1/07-1/20/08)

    Total – Interventional Studies 2,281 (100%)

    Studies by Registrant Type

    University, Other 1,397 (61%)

    Industry 645 (28%)

    US Federal (including NIH) 239 (11%)

    Studies by Facility Location

    US sites only 1,436 (63%)

    Non-US only 569 (25%)

    US & non-US mixed 73 ( 3%)

    Missing 203 ( 9%)


    Overall characteristics updated studies 12 1 07 1 20 08
    Overall Characteristics: Updated Studies(12/1/07-1/20/08)

    Total 10,558 (100%)

    Type of Trial*

    Observational 1,019 (10%)

    Interventional 9,535 (90%)

    - Drug, Biologic 8,080

    - Behavioral, Gene

    Transfer, Other 776

    - Medical Procedure 4,282

    - Device 329

    *4 records missing “Study Types” information


    Overall characteristics updated studies 12 1 07 1 20 081
    Overall Characteristics: Updated Studies(12/1/07-1/20/08)

    Total – Interventional Studies 9,535 (100%)

    Studies by Registrant Type

    University, Other 1,947 (21%)

    Industry 2,997 (31%)

    US Federal (including NIH) 4,591 (48%)

    Studies by Facility Location

    US sites only 5,746 (60%)

    Non-US only 2,006 (21%)

    US & non-US mixed 1,158 (12%)

    Missing 625 ( 7%)


    Delayed posting of device trial registrations
    Delayed Posting of Device Trial Registrations

    • Law appears to prohibit public posting of trials of devices that have not been approved/cleared by FDA –even whendesired by registrant

    • Would therefore:

      • Require removal from current database of some device trials voluntarily posted prior to passage of law

      • Preclude use of ClinicalTrials.gov for recruitment

      • Preclude use of ClinicalTrials.gov to comply with registration policy of journal editors (ICMJE)

      • Limit transparency of such trials funded by NIH or other gov’t agencies

    • Complaints received from some companies; some registrants are omitting approval/clearance status of devices to circumvent

    • HHS is studying possible options


    Device studies delayed posting
    Device Studies:Delayed Posting

    • Must answer “yes” to following: Indicate whether this is an unapproved or uncleared device trial for which posting to ClinicalTrials.gov should be delayed in accordance with US Public Law 110-85, Title VIII, Section 801.

    • 32 studies in “lock box” as of 2/7/08


    Overall interventional device studies 12 1 07 1 20 08
    Overall Interventional Device Studies (12/1/07-1/20/08)


    Delayed posting general characteristics
    Delayed Posting General Characteristics

    Total: 32 studies (as of 2/7/08)

    Provider Type

    27 Industry

    5 Other

    Study Type

    27 Interventional

    4 Expanded Access

    1 Observational


    Analysis of response overall
    Analysis of Response:OVERALL

    Data Completion Statistics forOverallActive Phase II-IV Drug/Device Interventional Trials Submitted(12/1/07 - 1/20/08)


    Top device companies
    Top Device Companies

    * Source: Not so Lonely at the Top. Medical Product Outsourcing (MPO), July/August 2007

    **All device interventional and observational studies registered at ClinicalTrials.gov as of 2/4/08

    ***Active, phase II-IV device interventional trials

    ****Includes: BiosenseWebster, ConorMedsystems, Cordis, Dupuy*, Ensure, Ethicon*, LifeScan, Visioncareinc


    Top pharmaceutical companies
    Top Pharmaceutical Companies

    * Source: Top 10 Companies by U.S. Sales. IMS Health, IMS National Sales Perspective.3/2007

    ** All interventional and observational studies registered at ClinicalTrials.gov as of 2/4/08

    *** Active, phase II-IV drug/biologic interventional trials


    Specific data element issues

    Specific Data Element Issues

    Public Law 110-85, Section 801

    PL 110-85 Implementation

    NIH Policy


    Evolution of data elements
    Evolution of Data Elements

    • ClinicalTrials.gov has included data elements necessary to accommodate many policies

      • FDAMA

      • ICMJE

    • Specific wording and structure of data elements has evolved with experience

    • FDAAA has incorporated previously optional ICMJE data elements—usually identified by overall title (without details)


    Nih policy board approval
    NIH Policy – “Board Approval”

    • Submitted studies should have approval from a human subjects review board prior to the recruitment of the first patient

    • Studies may be registered prior to board approval, if status is “Not yet recruiting”

    • Data Elements

      • Board Approval Status (e.g., “Submitted, exempt”)

      • Board Name

      • Board Affiliation

      • Board Contact


    Interventional study design
    Interventional “Study Design”

    • Each of the following elements is required

      • Intervention Model – intervention assignments (e.g., parallel arms)

      • Number of Arms – number of comparative groups

      • Masking – knowledge of intervention assignments (e.g., double blind)

      • Allocation – participant assignment to intervention arm (e.g., randomized)

    • Sources: ICH E3, 21 CFR 314.126


    Intervention name
    “Intervention Name”

    • Provides sufficiently detailed description of the intervention(s) and to link intervention(s) to arm(s)

    • Data Elements

      • Intervention Name: generic name for drugs; for others, sufficient detail to distinguish from similar interventions (e.g., devices)

      • Intervention Description: e.g., dosage

      • Arm Name or Label: way to identify arm

      • Arm Type: e.g., experimental, active comparator

      • Arm Description: if different from intervention description


    Enhance trial nct00552097
    ENHANCE TrialNCT00552097


    Catie nct00014001
    CATIENCT00014001


    Outcome measure
    “Outcome Measure”

    • Specific measurement that will be used to measure the effect of experimental variables in a study

    • Requires the following

      • Outcome Measure: Description of the specific measure

      • Outcome Time Frame: Time point(s) at which outcome measure is assessed

      • [Safety Issue? (yes/no)]


    Pl 110 85 implementation
    PL 110-85 Implementation

    • Safety Issue? – “the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome”

    • Facility Contact – location information (e.g., city, state, country) to be able to search by “location of the clinical trial”

    • Applicable Clinical Trial?

      • FDA Regulated Intervention? (Yes/No)

      • Section 801 Clinical Trial? (Yes/No)

      • Delayed Posting? (Yes/No)


    Other questions to address
    Other Questions to Address

    • Cut-off for modifying registry records?

      • Estimated completion date

      • Outcome measures

      • Target enrollment

    • Good enough outcome measure?

    • How should changes be displayed?


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