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OtherSPECIAL CONTRIBUTION

The Radioactive Drug Research Committee: Background and Retrospective Study of Reported Research Data (1975–2004)

Orhan H. Suleiman, Richard Fejka, Florence Houn and Maria Walsh
Journal of Nuclear Medicine July 2006, 47 (7) 1220-1226;
Orhan H. Suleiman
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Richard Fejka
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Florence Houn
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Maria Walsh
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    FIGURE 1. 

    Number and status of RDRCs by 5-Year Reporting Periods

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    TABLE 1

    RDRC Research: Number of Studies and Number of Human Subjects by Year

    YearRDRC studies (n)RDRC subjects (n)Studies with pediatric subjects (n)Pediatric subjects (n)Studies with pediatric subjects (%)All subjects who were pediatric (%)
    19761853133916.7% (3/18)7.3% (39/531)
    19812242,08812585.4% (12/224)2.8% (58/2,088)
    19862072,3108803.9% (8/207)3.5% (80/2,310)
    19912452,8339803.7% (9/245)2.8% (80/2,833)
    19962431,9586322.5% (6/243)1.6% (32/1,958)
    20011531,1080000
    20022802,8720000
    20032842,7970000
    • View popup
    TABLE 2

    Number of Active Studies per Active RDRC in 2003

    Committees conducting studiesActive studies (n)Human subjects (n)All 2003 human subjects (%)
    A312669.5
    B342519.0
    C142428.7
    D142147.7
    E162117.5
    F251936.9
    G151625.8
    H121545.5
    I161214.3
    J51164.1
    K7873.1
    L14853.0
    M18802.9
    N8682.4
    O2662.4
    Remaining 39 committees5348117 (<2% for each remaining committee)
    Total: 54 activeTotal: 284Total: 2,797100
    • View popup
    TABLE 3

    Distribution (%) of RDRC Research Subjects by Year and Nuclide Type Administered

    YearImaging nuclide (% positron emitter)Imaging nuclide (% γ-emitter)Nonimaging nuclide (% β-emitter)
    197657718
    1981123256
    1986301456
    199137855
    199655936
    200180416
    200377518
    • View popup
    TABLE 4

    Percentages of Specific Radionuclides Used in 2003 RDRC Studies by Imaging Type*

    Imaging nuclidesNonimaging nuclides
    Positron (total = 77%)γ (total = 5%)β (total = 18%)
    11C3799mTc2.503H12.40
    18F19123I1.3014C4%
    15O17.50131I0.3059Fe0.70
    13N2.60133Xe0.3045Ca0.30
    60Cu0.70111In0.2055Fe0.30
    17F0.50125I0.30
    94mTc0.2047Ca0.20
    65Zn0.20
    • ↵* Radioactive drug research studies conducted in 2003: 84 committees, 284 studies, 2,797 human subjects.

    • Values in alternate columns are expressed as percentages.

    • View popup
    TABLE 5

    Use of Multiple Nuclides in RDRC Studies by Year and Number of Nuclides

    YearStudies with 1 nuclide (%)Studies with 2 nuclides (%)Studies with 3 nuclides (%)Studies with 4 nuclides (%)
    197692.37.700
    198194.93.40.61.1
    198693.34.52.20
    199182.116.41.50
    199688.211.00.90
    200172.523.93.50
    • View popup
    TABLE 6

    Radiation Dose Limits for RDRC Subjects*

    Organ or systemSingle dose† (Sv)Annual and total dose† (Sv)
    Whole body0.030.05
    Active blood-forming organs0.030.05
    Lens of eye0.030.05
    Gonads0.030.05
    Other organs0.050.15
    • ↵* RDRC: Radiation Dose Limits—Code of Federal Regulations Title 21, Part 361.1 (b) (3).

    • ↵† 0.03 Sv = 3 rem.

    • For research subjects under 18 y of age at last birthday, the radiation dose does not exceed 10% of adult dose. Radiation doses from x-ray procedures that are part of the research study shall be included.

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Journal of Nuclear Medicine: 47 (7)
Journal of Nuclear Medicine
Vol. 47, Issue 7
July 2006
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The Radioactive Drug Research Committee: Background and Retrospective Study of Reported Research Data (1975–2004)
Orhan H. Suleiman, Richard Fejka, Florence Houn, Maria Walsh
Journal of Nuclear Medicine Jul 2006, 47 (7) 1220-1226;

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The Radioactive Drug Research Committee: Background and Retrospective Study of Reported Research Data (1975–2004)
Orhan H. Suleiman, Richard Fejka, Florence Houn, Maria Walsh
Journal of Nuclear Medicine Jul 2006, 47 (7) 1220-1226;
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