Personalized Cancer Medicine Needs Randomized Trials

June 24, 2016

IDDI organized a webinar on Personalized Cancer Medicine Needs Randomized Trials.

Clinical cancer research is undergoing profound changes, mostly because of the advent of personalized cancer medicines. Some remarkably efficacious drugs have even been approved based on uncontrolled phase I clinical trials.

In this webinar, our speakers challenged the view that the expected benefits from new personalized cancer medicines are generally sufficient to forgo randomization to a standard-of-care arm.

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Personalized Cancer Medicine Needs Randomized Trials

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  • In this webinar, our speakers challenged the view that the expected benefits from new personalized cancer medicines are generally sufficient to forgo randomization to a standard-of-care arm. Apparently improved outcomes in a single-arm early trial may be due to the prognostic nature of the target and to selection bias, rather than result from a true effect of therapy. Moreover, the predictive role of biomarkers cannot be ascertained in a definitive way without randomization to a control arm.
  • They started by reviewing the evolving nature of clinical research, especially with targeted agents, and the very promising examples of the approach to developing personalized cancer medicines. Then they claimed that randomization is an essential feature of clinical trials throughout the continuum of clinical drug development and discuss the potential loss of a clear demarcation between traditional phases of this development.
  • Implementing randomization throughout the continuum of development requires important statistical considerations, adaptive designs, and a change of focus from the drug alone to the drug/patient match.

Speakers:

  • Marc Buyse, ScD, Chief Scientific Officer at the International Drug Development Institute (IDDI).
    • He holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA).
    • He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe.
    • He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing (http://publicationslist.org/marc.buyse).
  • Everardo Saad, MD, Senior Medical Expert at the International Drug Development Institute (IDDI).
    • He has over 15 years of experience in Medical Oncology and clinical trial designs.
    • He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston.
    • After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.
Presentation of the Webinar: Personalized Cancer Medicine Needs Randomized Trials

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