Before any drug or treatment is taken to the pharmacies for marketing and selling, they undergo pharmaceutical clinical trials.
Pharma trials are conducted to find out if a drug or a treatment by any pharmaceutical company is effective. However, effectiveness of a treatment or a drug should not sacrifice the safety of individuals subjected to clinical trials.
For example, a new drug or treatment for high blood pressure is being used in pharmaceutical trials to find out its potency in slowing down the progression of Parkinson’s disease.
This type of clinical trial works by comparing groups of individuals taking different kinds of treatments for a single disease. They are usually divided in phases or series of steps.
Conducting pharmaceutical clinical trials
The initial steps are usually preclinical trials or experiments performed in the laboratory without the use of human beings. The aim of preclinical trials is to determine potential cures which can be ineffective and unsafe as well.
A new approach tested initially in humans allows researchers to determine what dose is safe or how the new drug should be given and how often. Comparisons are made to determine if the drug should be given through mouth, vein injection or muscle injection. The existence of harmful side effects are noted and carefully monitored.
The initial testing usually takes place in only few sites and involves a small number of patients and healthy volunteers.
A secondary phase of the trial evaluates effects of the new drug to the human body and focuses on a particular medical state.
The third phase of pharmaceuticals usually involve the comparison of the new agent with the current or standard medications. The volunteers are assigned to a new group at a random manner through a computer to avoid bias and make sure that human intervention or other factors will not adversely affect the results of the trial.
The trial advances to this phase only if the results of phase 1 and phase 2 are promising. The fourth phase of the trials provides further evaluation of the the effectiveness and long term safety of the treatment and only after the treatment has a thumbs up order for standard usage. Phase four of the trial may involve thousands of individuals.
The data collected from the trials after completing all phases of research are collated before providing a conclusion on the results including recommendations for further testing.
The results of the pharmaceutical trials are published in medical or scientific journals. However, experts are made to review them prior to publishing to ensure that the analysis and conclusions are accurate. The media is also involved after the results are considered a breakthrough in medical science. Discussions about the trial results in scientific gatherings and by patient advocacy groups are also encouraged prior to publishing.