Skip to main content

Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
Currently Skimming:

5 Challenges and Opportunities in Regulatory Science
Pages 39-46

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 39...
... Other key challenges identified by multiple workshop participants involved questions around the data themselves, such as ownership and access or curation and its associated costs. Finally, some participants struggled to fit the tools and the challenges into the overarching principle of improving regulatory science -- balancing innovation with rigor to enhance the efficiency, accuracy, and applicability of clinical trials without sacrificing safety to obtain the most efficacious and reliable treatments for disease.
Read the entire page →
From page 40...
... REGULATORY SCIENCE LANDSCAPE CONSIDERATIONS Role of Public Engagement in Regulatory Science Patients are more empowered and better informed than in the past; both the creation and use of data by patients could ultimately drive clinical or regulatory ecosystem behavior. One workshop participant noted that the regulatory science field should not underestimate the degree to which the most innovative users of data will increasingly be patients; in light of the current progress toward and investment in personalized medicine, there could be a corresponding drive toward patient-level approaches in regulating science applications.
Read the entire page →
From page 41...
... 1  The Academies recently published a consensus report titled Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. More information can be found at: www.­ nationalacademies.org/hmd/Reports/2015/Sharing-Clinical-Trial-Data.aspx (accessed June 20, 2016)
Read the entire page →
From page 42...
... Modeling Modeling, like other aspects of regulatory science, is undergoing immense change in response to the availability of big data. Innovative trial design, master trial protocols, Bayesian methods, and using consortia to understand disease are all dependent on the collection and use of data for the creation of knowledge and novel applications, said Darrell Abernethy.
Read the entire page →
From page 43...
... Their remarks are summarized below. • What are the major priorities for furthering innovative applications of regulatory science?
Read the entire page →
From page 44...
... Summary of Individual Participant Remarks Considerations for building, training, and rewarding an enlightened regulatory workforce generated much discourse and debate among workshop participants. Their remarks are summarized below.
Read the entire page →
From page 45...
... (Myers) o  Articulating the broad public health impacts of the work may help draw scientists into the field.
Read the entire page →

Key Terms

  • regulatory scientists
  • clinical trial
  • medical product
  • major priorities
  • clinical trials

  • data ownership
  • science landscape
  • science workforce
  • participants thought
  • trial design

  • innovative trial
  • health impacts
  • personalized medicine
  • current regulatory
  • innovative regulatory

  • enlightened regulatory
  • evaluate regulatory
  • regulatory workforce
  • plinary regulatory
  • improving regulatory

  • regulatory ecosystem
  • regulatory foundation
  • regulatory decisions
  • studied postapproval
  • identified throughout

  • pharmaceutical companies
  • brian strom
  • encouraging collaboration
  • ongoing training
  • workforce considerations


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.