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Clinical Studies

  • Susann Wienecke
  • Bianca Deparade-BergerEmail author
Chapter

Abstract

Medical and surgical therapy for complicated IBD patients is often unsatisfactory, and the disease burden remains high despite optimal therapy. To optimise medical therapy, clinical research is necessary in order to develop new therapeutic options as well as diagnostic procedures to understand how diseases begin, progress and can be treated. This is where clinical research becomes an essential aspect of IBD care looked at from a wider perspective. It can be performed either by observation or prospective clinical trials. Clinical trials generate data on safety and efficacy of new drugs or procedures. Understanding different trial approaches is important for IBD nurses; many of whom are directly involved in the care of these patients. Any such nurse is the essential link between patients, physicians and sponsor. Clinical knowledge in IBD is critical not only to detect and document adverse events but also to meet the given endpoints of a clinical study. Study knowledge is important to help patients and colleagues navigate increasingly complex study designs which must appropriately address a wide variety of research questions. While clinical knowledge is addressed elsewhere in this manuscript, this chapter will address key designs, trial terminology and the application of:
  • The four phases of clinical trials

  • Study designs and key aspect of these such as endpoints

  • The practicalities of setting up a clinical trial

  • Ethical principles practically applied throughout a study, particularly in discussion with participants

  • How studies deal with adverse events

  • Individual roles in the study team

Keywords

Trial phases Placebo-controlled Proof of concept Pharmacokinetics Interventional/non-interventional Clinical trial Feasibility Initiation Pre-study Close-out visit Screening Randomisation AE SAE PI SI Study nurse Monitor Archiving Deadlines 

Abbreviations

AE

Adverse event

CRA

Clinical research associate

CRF

Case report form

CRO

Clinical research organisation

CSR

Clinical study report

CV

Curriculum vitae

DAL

Drug accountability log

EC

Ethics committee

eCRF

Electronic case report form

EDC

Electronic data capture

EOS

End of study

EOT

End of therapy

ET

Early termination

eSR/SD

Electronic source record/Source data

EUDRA

European Union Drug Regulatory Authorities—EUDRA CT Nr.

FDA

Food and Drug Administration

GCP

Good clinical practice

IB

Investigator’s brochure

IC

Informed consent

ICF

Informed consent form

ICH

International Conference on Harmonisation

IF

Investigator file

ISF

Investigator site file

NIS

Non-interventional study

NA/NK

Not applicable/Not known

ND

Not done, not documented

PI

Principal investigator

SAE

Serious adverse event

SAR

Serious adverse reaction

SD

Source data

SDV

Source data verification

SF

Screening failure

SC

Study site coordinator

SUAE

Serious unexpected adverse event

SUSAR

Suspected unexpected serious adverse reaction

TMF

Trial master file

WHO

World health organization

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Ambulanzzentrum Gastroenterologie am Klinikum LueneburgLueneburgGermany
  2. 2.Department of Gastroenterology, DRK Kliniken Berlin | WestendBerlinGermany

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