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Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression Workshop Summary (2015) / Chapter Skim
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5 Regulatory Issues
Pages 43-48

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From page 43...
... Regulatory agencies have one central goal: to ensure the safety and effectiveness of a variety of medical products, including both drugs and devices. With regard to products targeting cognitive impairment in depression, regulatory approval of any product has yet to be achieved.
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From page 44...
... WORKING WITH REGULATORS: FDA AND EMA While the job of sponsors is to put their best case forward to regulatory agencies and back it up with data, the job of the regulators is to evaluate the evidence, identify data gaps, and ensure that the claims made by the sponsor are supported by the data, said Tiffany Farchione. The burden is on the sponsor to make the case for the target population and possible enrichment strategies; the scientific rationale for targeting specific domains and using adjunctive versus monotherapy; the trial design (e.g., active comparator versus placebo controlled)
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From page 45...
... STUDY POPULATION AND ASSESSMENT With regard to defining the target population, several workshop participants identified that the challenge for sponsors is to sort out the specific population that should be targeted for treatment development programs and decide whether to target cognition broadly or whether to home in on a particular domain that may be impaired in a specific subgroup. As described earlier, many cognitive domains may be impaired in people with depression, and different subgroups may have different impairments that may require different treatments.
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From page 46...
... These data have led regulatory agencies to endorse cognitive impairment in schizophrenia as a legitimate target. Regulators have also endorsed other narrow targets for drug development such as agitation in schizophrenia and bipolar disease, indicating that they are willing to accept a narrow target if the data support it.
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From page 47...
... FUTURE DIRECTIONS Diego Pizzagalli asked whether regulators might consider a neurophysiologic change as a primary outcome with a functional improvement as the co-primary. Laughren broadened the question to ask, at what point will our understanding of behavior at a biological level allow the abandonment of artificial DSM categories and move instead to look at actual domains of function?
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From page 48...
... 48 COGNITIVE DYSFUNCTION IN DEPRESSION provide a legitimate claim for a more general indication. The key, said Farchione, is having sufficient data to prove that an improvement is generalizable across multiple disease conditions.
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Key Terms

  • cognitive dysfunction
  • regulatory approval
  • targeting cognitive
  • clinically meaningful
  • targeting specific

  • meaningful change
  • functional improvement
  • tive impairment
  • target population
  • specific domains

  • urged sponsors
  • treatment development
  • handles regulation
  • regulatory scrutiny
  • design stage

  • validated outcome
  • hold joint
  • address cognitive
  • specific subgroup
  • abstract cognitive

  • defined parameters
  • joint discussions
  • trial design
  • versus monotherapy
  • separate responses

  • medicine devices
  • earlier chapters
  • future directions
  • neurobiological understanding
  • scientific officer


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