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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

slide2
Pilot Quality Control Project
  • Recommendation to Secretary – Narrative Summaries

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
slide13
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
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
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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