In the medical industry, there are a range of clinical trials conducted by different pharmaceutical companies to determine the effectiveness of a drug, device or medicinal regime among a small or huge group of human specimens. The commencement of the clinical trial begins with a study sponsor and a protocol. In most situations, the pharmaceutical company that is investing in the clinical trial prepares a specific protocol for a clinical trial. In layman’s language, a protocol is a plan formed to determine how the trial will work, what will be implemented during the trial and the reason for which a trial is being conducted by a pharmaceutical company.
Information to be included in Protocol of a clinical trial
The essential information that should be incorporated in a protocol of a specific clinical trial would be as follows:
1. The number of participants
2. The eligibility of the human specimen
3. The nature and duration of the tests carried out on the patients.
4. The type of data that is to be gathered by the researcher
5. Comprehensive information about the treatment plan
Standards followed by clinical researchers in a clinical trial
Clinical researchers are also taught to follow a certain code of ethics and specific standards of research while they undergo various certifications and assessments during a clinical research training course. Firstly, it is essential that they must avoid biases which are human choices or other factors that are not linked to the protocol. To exemplify if the doctors had the choice to assign patients to comparison groups in a study, some might assign sicker patients to the treatment group and healthier patients to the group that is not being treated. As a result of these biases, the doctors might not even realize they are doing this, and it could affect trial results.
Randomization and blinding in clinical trials
Furthermore, to eliminate the various biases that could occur during the procedure, clinical researchers implement the procedure randomization which involves the assigning of participants to a group by chance rather than the choice of the researcher. In addition to these standards followed in a clinical trial, a clinical research professional could utilize the procedure of blinding to eliminate biases in a clinical trial . In a blinded clinical trial, researchers are totally unaware of the patients receiving the experimental drug and the ones receiving a placebo.
Phases of a clinical trial process
Pharmaceutical companies are aware of the fact that there are four phases of interventional CLINICAL trials in order to be approved by the certifying body and to be made available to the general public.
First phase : Safety of an experimental drug
The duration of the first phase of a trial is for a month and includes ten to twenty people in a study . The man aim of thus phase is to determine the safety, of the drug, and the side effects of the drug on the human body.
Second Phases: Impact of the drug on participants
The second phase lasts for a period of three to twelve months and takes place approximately among a group of fifty to seventy five people . It focuses on how well the drug works on the human specimens and the dosage of the experimental drug to be taken by the participants.
Third Phase: Is the drug helpful or risky for the participants
The third phase goes on for a duration of six to twelve months and involves approximately a group of hundred to three hundred people . This phase is carried out to determine the benefits a drug may bring or the harm that it could cause to the public.
To conclude, In order to conduct a successful clinical trial, medical aspirants need to undergo a clinical research training course to raise the standards of research in the clinical research sector. Once a person completes a clinical research training or certification, it will definitely help the individual to comply with the standards set by the certifying body in the clinical research industry.
