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Clinical trial design for progressive MS trials

Matteo Pardini1, Gary Cutter2, Maria Pia Sormani3

  • 1Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy/Policlinic Hospital San Martino-IST, Genoa, Italy.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|October 19, 2017
PubMed

Insights

Designing clinical trials for progressive multiple sclerosis (PMS) is challenging. This review evaluates key issues in PMS trial design, including patient selection and outcome measures, to improve treatment effect detection.

Area of Science:

  • Neurology
  • Clinical Trial Design
  • Neuroimmunology

Background:

  • Effective clinical trial design is crucial for detecting treatment effects, especially in progressive multiple sclerosis (PMS).
  • Phase-2 studies for PMS face significant challenges regarding appropriate target and outcome selection.
  • Uncertainty in these areas can hinder the development of effective therapies.

Purpose of the Study:

  • To critically evaluate the current challenges in designing clinical trials for progressive multiple sclerosis.
  • To identify key considerations for optimizing PMS clinical trial protocols.
  • To provide insights for improving the success rate of PMS therapeutic interventions.

Main Methods:

  • This review synthesizes current literature on clinical trial design specific to progressive multiple sclerosis.
  • It examines challenges related to patient stratification and recruitment in PMS studies.
  • The review analyzes the suitability of various instrumental and clinical outcome measures for PMS trials.

Main Results:

  • Patient selection criteria significantly impact the ability to detect treatment effects in PMS trials.
  • Instrumental and clinical outcomes require careful validation for relevance and sensitivity in progressive disease.
  • Design complexities in PMS trials necessitate adaptive or innovative approaches.

Conclusions:

  • Addressing challenges in patient selection and outcome measures is vital for robust PMS clinical trial design.
  • Optimizing trial design can enhance the likelihood of identifying effective treatments for progressive multiple sclerosis.
  • Further research into novel trial methodologies is recommended for PMS studies.
Keywords:
Progressive multiple sclerosisclinical trial design

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