{"id":7407,"date":"2024-07-26T13:21:54","date_gmt":"2024-07-26T17:21:54","guid":{"rendered":"https:\/\/labs.icahn.mssm.edu\/tcibci\/?page_id=7407"},"modified":"2025-08-26T16:38:37","modified_gmt":"2025-08-26T20:38:37","slug":"bdw","status":"publish","type":"page","link":"https:\/\/labs.icahn.mssm.edu\/tcibci\/bdw\/","title":{"rendered":"BDW"},"content":{"rendered":"

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Biostatistics Design Workshop (BDW)<\/b><\/h1>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.9.0″ _module_preset=”default” background_color=”RGBA(0,0,0,0)”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Fullwidth Text Over White Background – Section” module_class=”section_fulllwidth_text_simple” _builder_version=”4.9.0″ locked=”off” collapsed=”off”][et_pb_row admin_label=”row” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text admin_label=”purpose” _builder_version=”4.9.0″ _module_preset=”default”]<\/p>\n

Purpose<\/b>: The BDW is comprised of statisticians from the TCI Biostatistics Shared Resource and provides a forum for statistical collaboration on the development, design, and analysis of interventional investigator initiated (I-IIT) protocols. It is the first step in the I-IIT process flow and BDW approval is required<\/u>\u00a0before submission of protocols to DFG meetings.<\/p>\n

[\/et_pb_text][et_pb_text admin_label=” Eligibility for BDW Review” _builder_version=”4.9.0″ _module_preset=”default”]<\/p>\n

Eligibility for BDW Review<\/strong>
A protocol requires BDW review<\/strong> only if it meets both<\/strong> of the following criteria:<\/p>\n

    \n
  1. Interventional Study<\/strong><\/li>\n<\/ol>\n

    A prospective study in which individuals are assigned by an investigator, according to a protocol, to receive specific interventions (e.g., diagnostic, therapeutic, behavioral). Assignment of the intervention may or may not be randomized. Participants are followed, and biomedical and\/or health outcomes are assessed.
    Note: This includes molecular and imaging diagnostic trials in which the test results affect medical decision-making.<\/em><\/p>\n

      \n
    1. Investigator-Initiated Study<\/strong><\/li>\n<\/ol>\n

      The Mount Sinai PI must hold the IND or IDE<\/strong>. If the IND or IDE is held by an external sponsor (e.g., pharmaceutical company, cooperative group, or another institution), the protocol is not considered an I-IIT and does not require BDW review<\/strong>.<\/p>\n

      Exemptions<\/strong>
      Protocols that meet the two criteria above (interventional + Sinai-held IND\/IDE) do not require BDW review<\/strong> if they have already undergone full scientific and biostatistical review by an approved external organization<\/strong>.
      \ud83d\udc49 View List of exempting organizations<\/a><\/p>\n

      [\/et_pb_text][et_pb_image src=”https:\/\/labs.icahn.mssm.edu\/tcibci\/wp-content\/uploads\/sites\/505\/2024\/07\/IIT_flow.png” title_text=”IIT_flow” align=”center” admin_label=”IICT Process Flow” _builder_version=”4.9.0″ _module_preset=”default” max_width=”60%” max_height=”500px”][\/et_pb_image][et_pb_text admin_label=”BDW Development” module_id=”ICTD” _builder_version=”4.9.0″ _module_preset=”default”]<\/p>\n

      BDW Protocol Development<\/b><\/h2>\n

      [\/et_pb_text][et_pb_text admin_label=”Early Contact” _builder_version=”4.9.0″ _module_preset=”default”]<\/p>\n

      Early Contact<\/b>: All investigators are encouraged to contact a biostatistician early in the development stage of their protocol to obtain advice on:<\/p>\n