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Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble).

Shivam Joshi
Published in: Trials (2023)
Trials need to be critically reviewed by various stakeholders and have sufficient time allocated to planning and feasibility assessments to avoid some amendments. This may improve clinical trial efficiency, to benefit the trial participants, researchers, funders, sponsors, and regulatory bodies, and potentially bring new treatments to patients faster.
Keyphrases
  • clinical trial
  • phase ii
  • study protocol
  • end stage renal disease
  • phase iii
  • ejection fraction
  • newly diagnosed
  • open label
  • chronic kidney disease
  • prognostic factors
  • peritoneal dialysis
  • double blind