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Neuroscience Trials of the Future Proceedings of a Workshop (2016) / Chapter Skim
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4 Transforming Clinical Trials with Technology
Pages 37-42

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From page 37...
... New technologies are disrupting all industries, including health care and drug development, said Amir Kalali, head of the Neuroscience Center of Excellence at Quintiles. Although they have yet to make a major impact in clinical trials, technological innovations offer the potential to improve efficiency and productivity through the use of novel outcomes, increased patient engagement, reduced patient burden, and improved trial management.
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From page 38...
... The R&D and business models upon which these companies have been built may be adaptable to pharmaceutical development, said Glen de Vries, president and co-founder of Medidata Solutions. Kalali also mentioned other technologies that are likely to disrupt the drug development enterprise such as synthetic biology -- so-called exponential technologies because they are developing at an exponential rate.
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From page 39...
... Bringing patients into the process -- for example, understanding what matters to them and what the trial should measure -- would help ensure that research is addressing clinically relevant questions, said Carlos Rodarte, chief executive officer of Health Rhythms. In addition, listening to what patients say about how they feel may provide clues about unexpected aspects of the treatment response, said Perry Nisen.
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From page 40...
... Rodarte, however, said that with a large enough sample size, it might be possible to identify the outliers; and Reites added that connecting directly with electronic medical records can provide added confirmation that participants are who they say they are. Simple online assessments, data capture by wearable devices, remote monitoring, and virtual clinical visits offer additional advantages in terms of reducing patient burden, and this can have a substantial impact on recruitment and retention, said Schiller.
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From page 41...
... However, Greg Koski, chief executive officer, president, and cofounder of the Alliance for Clinical Research Excellence and Safety (ACRES) , noted that although implementation of Clinical Data Interchange Standards Consortium (CDISC)
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From page 42...
... at the FDA. To what extent does the treatment affect how the patient feels, functions or survives; how do you measure this?
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Key Terms

  • drug development
  • data capture
  • social media
  • virtual clinical
  • clinical visits

  • increased patient
  • patient burden
  • patient engagement
  • consumer technology
  • technology companies

  • novel outcomes
  • clinical data
  • clinical trial
  • neuroscience clinical
  • william potter

  • schiller cautioned
  • science institute
  • greg koski
  • health rhythms
  • development enterprise

  • traditional drug
  • change radically
  • medical records
  • increasing focus
  • reducing patient

  • change standards
  • changes brought
  • tools continuous
  • central focus
  • using technology


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