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JCO Makes Protocol Information Available for Randomized Phase II and III Studies

Jun 22, 2011

Since 2009, the Journal of Clinical Oncology (JCO) has required submission of protocols for all randomized phase II and phase III studies in order to help facilitate manuscript review. Because space constraints limit the details that can be included in a published article, the editors recently decided to make the following redacted portions of the most recent protocol available online to readers upon publication of the article:

  • Selection of patients, including both eligibility and ineligibility criteria
  • Schema and treatment plan, including administration schedule
  • Rules for dose modification
  • Measurement of treatment effect, including response criteria, definitions of response and survival, and methods of measurement
  • Reasons for early cessation of trial therapy
  • Objectives and entire statistical section (including endpoints) For further information, please see the March 20, 2011, JCO editorial, “Providing Protocol Information for Journal of Clinical Oncology Readers: What Practicing Clinicians Need to Know.”

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