What is Clinical Trial M edicine (CTM )?
Clinical trial medicine is defined as the science of designing, conducting and interpreting clinical trials. Clinical trials are concerned with finding and providing therapies for a group of patients with a disease. Patient safety is the most important priority in clinical trials. The well being of patients and healthy volunteers always comes first in any clinical trial (Chin and Lee 3).
There are different stages of clinical research medicine:
All new medicines must undergo Phase 1 – 3 clinical trials before they are submitted to regulatory authorities for an approval to market. However they must begin with preclinical testing to verify that a drug is sufficiently safe and effective to be tested in humans, followed by clinical (human) tests to verify the drug’ s safety and efficacy for its proposed use.
Preclinical: The objective is to establish pharmacology and toxicology profiles, drug development formulation and secure authorization to test in humans.
Phase I : Clinical testing of a new compound is used in humans for the first time and is usually limited to healthy volunteers. During this stage we establish pharmacokinetics, pharmacodynamics and dosing regimens. We also assess safety issues. Approximately 20 – 100 healthy volunteers participate.
Phase II : During this stage proof of concept, testing of safety and efficacy (small scale) and evaluation of possible side effects are established. Approximately 100 – 500 patients with the disease participate.
Phase III : Safety and efficacy (large scale) is confirmed during this stage. Adverse reactions from long-term use are monitored. The indication is also expanded. Approximately 1,000 – 5,000 patients with the disease participate.
Phase IV: This stage is when the medicine has been approved by regulatory authorities and we continue to evaluate safety and generate data about how the drug affects specific groups of patients (e.g. the elderly, WOCBP). The number of patients involved will vary by size and make up (Campbell 79-80).
We have a vast range of consultants with experience in global Phase I – IV clinical trials and we can provide a group of consultants tailored to meet your needs.
Cardiovascular – hands on experience on a device (stents) study that was designed to show the continued safety and efficacy of the stent during commercial use in real world settings.
Central Nervous System (CNS) – hands on experience from clinical trials for bipolar disorders, analgesia and Major Depressive Disorder (MDD) patients.
Hematology – hands on experience in clinical trials for patients with iron deficiency anemia.
Infectious Diseases – hands on experience in clinical trials for children between 12-23 months of age for vaccination against varicella.
Neurology – hand on experience in clinical trials for subjects with Alzheimer’s Disease.
Oncology – hands on experience in clinical trials for subjects with refractory solid and liquid tumors.