Clinical research is important for the discovery of new treatments. A clinical trial determines whether a drug is effective and sufficiently safe to be on the public market. Medical knowledge about the drug in question is gained through direct and indirect measures (blood and tissue abnormalities) of drug users. Digitalisation allows the collection of more data online, which enables a clinical research specialist to develop better treatment plans as more specific information is available. Clinical research allows the diagnosis of certain diseases and potentially prevention of these diseases in the future.
A clinical trial is a form of a clinical research that has been developed to answer a specific question through an experiment. These questions are related to possible new treatments or new ways of using an existing treatment. A clinical trial is a long and careful process that determines the safety and effectiveness of a new drug. This process consists of several phases:
Before the trial can begin, it must be approved by the Institutional Review Board (IRB). Before even being considered by the IRB, the trial has to meet a large number of scientific criteria. The IRB reviews trials before, but also during the trial, to make sure all the criteria are met at all times. All criteria are set to maximise the safety of the patient. The approval of each phase is dependent on the success of the previous phase.
A phase I clinical trial involves a relatively low number of participants as compared to the other phases. The main purpose of a phase I clinical trial is to examine whether the new type of medicine is safe for the patients and what the possible side effects could be. Moreover, during a phase I trial it is investigated what the most effective way of giving the medicine to the patient is (orally, by injection, or intravenously). The effectiveness of the new medicine is not yet the main focus during phase I.
If the phase I trial shows that the new medicine is safe, the phase II trial can start. In this trial, the effectiveness of a new medicine for the disease in question is tested. Compared to the phase I trial, the phase II trial has a larger number of participants. If the studied disease has several forms, this phase will narrow the focus to one particular form or type of the disease. Furthermore, in this trial the dosages of the new medicine are specified per participant.
The final phase of the clinical trial is conducted mostly at hospitals, general practices, and clinics located throughout a large area. Because this phase has a very large group of participants, there are different protocols for different groups of participants. The participants that are new to the phase ||| trials are physically examined, must give their medical history, and sign consent forms. When all the participants are examined and accepted, the pool of participants is divided into two groups. The first group will receive the new medicine, and the second group will receive the standard treatment. The trial will show if participants show a decrease of symptoms when taking the new medicine as compared to the standard treatment.
QTC Recruitment actively fills various positions in clinical research for medical devices, pharmaceutical, and clinical research organisations in the life sciences industry. Examples of positions are: a biostatistician who analyses data and determines the causes and issues affecting living organisms. Another regularly filled position is a data manager who oversees the development and use of data systems. Other positions that are recurrent at QTC Recruitment are the positions of a clinical project manager who plans and manages all aspects of a clinical trial, and the position of clinical research associate (CRA) who runs the clinical trials which are explained above. Other examples are a clinical safety specialist and statistical programmer positions. A clinical safety specialist is responsible for the overall safety and oversight of clinical studies. A statistical programmer plays a leading role in all programming tasks which are needed for the analysis and report of a clinical trial.