Clinical pharmacology applications in clinical drug development and clinical care: A focus on Saudi Arabia

Abstract

Drug development, from preclinical to clinical studies, is a lengthy and complex process. There is an increased interest in the Kingdom of Saudi Arabia (KSA) to promote innovation, research and local content including clinical trials (Phase I-IV). Currently, there are over 650 registered clinical trials in Saudi Arabia, and this number is expected to increase. An important part of drug development and clinical trials is to assure the safe and effective use of drugs. Clinical pharmacology plays a vital role in informed decision making during the drug development stage as it focuses on the effects of drugs in humans. Disciplines such as pharmacokinetics, pharmacodynamics and pharmacogenomics are components of clinical pharmacology. It is a growing discipline with a range of applications in all phases of drug development, including selecting optimal doses for Phase I, II and III studies, evaluating bioequivalence and biosimilar studies and designing clinical studies. Incorporating clinical pharmacology in research as well as in the requirements of regulatory agencies will improve the drug development process and accelerate the pipeline. Clinical pharmacology is also applied in direct patient care with the goal of personalizing treatment. Tools such as therapeutic drug monitoring, pharmacogenomics and model informed precision dosing are used to optimize dosing for patients at an individual level. In KSA, the science of clinical pharmacology is underutilized and we believe it is important to raise awareness and educate the scientific community and healthcare professionals in terms of its applications and potential. In this review paper, we provide an overview on the use and applications of clinical pharmacology in both drug development and clinical care.

Metabolomics of clinical samples reveal the treatment mechanism of lanthanum hydroxide on vascular calcification in chronic kidney disease

“…However, drug development, from preclinical research to clinical research, is a long and complicated process. 35 ) The development of new therapeutic agents is a multi-stage process with ethical, scientific, and economic challenges. 36 ) The probability of successful clinical development is about 10%, and few drugs prove to be effective in clinical trials.…”

The Characteristics of Clinical Studies Submitted to the Saudi Food and Drug Authority from 2009 until 2020

“…There is a paucity of data regarding the characteristics of clinical studies registered in the administration of clinical trials and the Saudi Clinical Trials Registry (SCTR). Saudi Food and Drug Administration ( SFDA ) established clinical trials administration and SCTR in 2009 and 2013, respectively ( Bawazir et al, 2014 , Ali et al, 2017 , Alsultan et al, 2020 ). The prime responsibilities of the clinical trial administration are to evaluate the protocols of clinical trials and amendments, conduct inspections based on the Good Clinical Practice, and maintain SCTR ( Bawazir et al, 2014 , Alsultan et al, 2020 ).…”

“…Saudi Food and Drug Administration ( SFDA ) established clinical trials administration and SCTR in 2009 and 2013, respectively ( Bawazir et al, 2014 , Ali et al, 2017 , Alsultan et al, 2020 ). The prime responsibilities of the clinical trial administration are to evaluate the protocols of clinical trials and amendments, conduct inspections based on the Good Clinical Practice, and maintain SCTR ( Bawazir et al, 2014 , Alsultan et al, 2020 ). SCTR is currently a comprehensive database of all clinical trials in the KSA ( SFDA ).…”

“…SCTR is currently a comprehensive database of all clinical trials in the KSA ( SFDA ). Since 2013, sponsors and researchers must register their clinical trials using the electronic portal of the SCTR ( Alsultan et al, 2020 ). A previous study in the KSA reported the findings from ClinicalTrials.gov which is managed by the National Library of Medicine at the National Institute of Health in the United States ( Zarin and Keselman 2007 ).…”

External Validation of Obese/Critically Ill Vancomycin Population Pharmacokinetic Models in Critically Ill Patients Who Are Obese

“…One approach to improve vancomycin dosing in critically ill patients who are obese is through the use of model‐informed precision dosing (MIPD) 14–17 . MIPD employs population pharmacokinetic modeling techniques to optimize dose selection for an individual patient.…”