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CNS Clinical Trials Suicidality and Data Collection: Workshop Summary (2010) / Chapter Skim
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4 Partnerships, Opportunities, Collaboration
Pages 35-42

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From page 35...
... Furthermore, it is key to understand longitudinal trends and their predictive relationship to suicidality. Madhukar Trivedi of the University of Texas Southwestern Medical Center at Dallas focused his presentation on the lessons learned from a 5year depression trial, enrolling about 4,000 adults and sponsored by the National Institute of Mental Health (NIMH, 2009)
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From page 36...
... Formally known as Star* D, the Sequenced Treatment Alternatives to Relieve Depression trial used a common set of outcome measures, including one three-part question covering suicidal ideation and behavior, which was the centerpiece of Trivedi's presentation.
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From page 37...
... These findings suggest the importance of tracking suicidal ideation because a small percentage of patients do worsen and their risk factors are becoming clear. THE FDA'S CRITICAL PATH INITIATIVE Lack of progress in studying and treating suicidality is part of a broader trend in the United States.
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From page 38...
... Under the auspices of the Critical Path Initiative, the FDA is committed to promoting development of the infrastructure and furnishing tools to make product development more efficient and streamlined. It hopes to help sponsors predict early in the development process which products are most likely to be safe and effective, thereby avoiding expensive product failures in the later stages of development.
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From page 39...
... Submission of dossiers to the FDA does not automatically constitute "fit for purpose," the legal term for a method of measurement that satisfies the FDA's standards for appropriateness and quality. Some common themes driving the Critical Path Initiative include identifying the public health need, determining whether partners are willing to share data precompetitively, identifying needed data standards, and sharing data in the public domain as quickly as appropriate.
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From page 40...
... The ECG warehouse, which is mandatory under the Food, Drug, and Cosmetic Act, is intended to enable academic and industry researchers to find better biomarkers of cardiac toxicity. The purpose is to develop more efficient clinical trial outcome measures and improve patient safety, given that the utility of the Q-T interval, a measure of the heart's electrical cycle, has been seriously questioned.
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From page 41...
... , the inclusion of biomarkers such as genetic data, the inclusion of comorbidities, longitudinal data, efficacy data, and the protection of corporate secrets. Participants were intrigued by the proposal laid out by Beasley, although what is left to discuss is how best to move forward, who should be at the table, and under what auspices the discussions would be held and advanced.
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Key Terms

  • critical path
  • path initiative
  • data sharing
  • clinical trials
  • practicing clinicians

  • adverse events
  • outcome measures
  • sharing data
  • data standards
  • serious adverse

  • suicidality studies
  • quick inventory
  • eli lilly
  • patient safety
  • risk factors

  • depression trial
  • help practicing
  • suicidal attempt
  • critical data
  • covering suicidal

  • report suicidal
  • suicidal acts
  • mild suicidal
  • tracking suicidal
  • depressed patients

  • sequenced treatment
  • beasley predicated
  • themes driving
  • widespread impediments
  • efficient clinical


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