Category: Health Science

In recent years, the importance of diversity in clinical trials has come to the forefront of medical research. As healthcare innovations advance, clinical trials must reflect the broad spectrum of patients who will ultimately use these treatments. Unfortunately, diverse patient representation in clinical research remains challenging, particularly for historically underserved communities. At TOTAL Diversity Clinical Trial Management, we are committed to breaking down these barriers and leading toward more inclusive clinical trials. Our mission is simple: to ensure that people of all racial, ethnic, and socioeconomic backgrounds have access to clinical trials designed to be inclusive and provide safe and effective treatments for everyone. Why Is Diversity in Clinical Trials So Important? The lack of diversity in clinical research can result in incomplete data that limits our understanding of how…

Critically discuss the pharmacological evidence that would be needed to justify clinical development: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describe the aims of preclinical testing in their M3 guidance as “[The characterisation of the] toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility..[and] to characterise potential adverse effects” (ICH, 2009). Non-clinical studies ensure that the Investigational medicinal product (IMP) pharmacokinetic (PK) and pharmacodynamic (PD) properties can be determined. Bioavailability studies, mechanisms of ADME (absorption, distribution, metabolism and elimination), safety pharmacology studies, toxicity studies and the assessment of potential genotoxicity, mutagenicity and carcinogenicity are all critical to carry out (Andrade et al., 2016). The drug half-life reflects the distribution and elimination of the drug and…