Clinical Studies & Empirical Ethics

 

About

The Clinical Studies and Empirical Ethics Department (CS&EE) conducts clinical, pharmacokinetic, and empirical ethics studies and educates and trains research professionals. It also provides infrastructure for qualified clinical and empirical ethic research by members of KFSH&RC and aspires to promote collaboration among basic scientists and clinical investigators. The Department maintains the vision of a world-class entity, and is guided by the core values of Islamic morality, clinical caring, scientific quality, artistic creativity, social responsibility, and industrial productivity. The Department has three sections: clinical studies, empirical ethics, and drug analysis laboratory.

 

Principle Activates

During the last 3 years, the Department has published 28 papers and its educational activities have been accredited with 461 CME hours by the American Association of Continuing Medical Education.

Sections:

  • Clinical Studies

The section conducts, facilitates the conduct of, clinical studies, including bioequivalence studies. Bioequivalence studies compare the rate and extent of absorption of two formulations of the same drug to ensure that locally-made generic drugs fulfil regularity requirements. The section also offers two modules of a semi-annual Clinical Research Professionals' Course: 1) Clinical Studies' Designs, Methods, and Analysis Module (2 weeks), accredited with 30 CME hours by the Saudi Commission for Health Specialties (SCFHS) and 49.25 CME hours by the American Association of Continuing Medical Education (AACME), and 2) Clinical Research Activities Module (1 week), accredited with 22 CME hours by the SCFHS & 24.5 hours by the AACME. The facility consists of a research clinic and a waiting area and is equipped with phlebotomy chairs, crash carts, ultrasound machine (Titan, portable), EKG machine (MAC 5500), I-Lyte NA/K/CL analyzer, I-Lab 300 auto chemistry analyzer, CBC Coulter Ac.T diff, digital weighing scale (Tronix), vital signs system (Dinamap pro 300v2), and life scan glucometer.

  • Empirical Ethics

Empirical Ethics Section: The section conducts empirical ethics studies that are relevant to the Saudi population. Although perception ought to govern the generation of ethical issues, reality (rather than perception) must often govern their resolution. Several widely held ethical views that were based on normative ethical perspectives did not stand empirical testing. Thus, there has recently been a move toward evidence-based bioethics like that in medicine. The section also offers one module of the semi-annual Clinical Research Professionals’ Course: Experimental and Philosophical Approaches to Ethics: Application to Clinical Research Module (1 week), accredited with 22 CME hours by SCFHS and 29.50 CME hours by the AACME.

  • Drug Analysis Laboratory

Drug Analysis Laboratory: The laboratory performs drug assay method development and validation, therapeutic drug monitoring, and pharmacokinetic analysis. It has developed and validated over 50 assays per international standards. The section also offers a Semi-Annual Liquid Chromatography: Concepts and Hands-On Training Course. The laboratory is equipped with five Waters Alliance HPLC systems and multiple detectors (ultraviolet (UV), photodiode array (PDA), fluorescence (FL), and electrochemical (ECD)), ultra-performance liquid chromatography (Aquity), Micro Mass Quattro Mass spectrometer (LC-MS/MS) system, and Waters® Xevo® TQD (LC-MS/MS) system.