Research in Clinical Trial Phase 1
The Clinical Trial Phase 1 is regarded as gatekeeper of any clinical research. This is because in this particular phase, potential new drugs or treatment is administered to human beings for the very first time. This is also called FIM or First-in-Man trial. Previously, near about 20to 80 volunteers were carefully screened in order to participate in this trial process. However, this is not so any more. Recent drug safety concerns revealed that adverse reactions are observed among the volunteers. The advancement of medical sciences developed treatments having greater specificity and this phase 1 treatment is now increasingly considered by patients.
In Clinical Trial Phase 1, the way the patients are involved brings in a new dimension to the whole concept of research. Patients truly benefit from these clinical trials and in these trials, both doctors and patients also consider other alternative methods of treatment. The benefit lies in the fact that the patients of this phase normally are not paid. So, these ethical considerations also play a major role in enrolling patients. In course of medical care, the willingness or autonomy of patient also assumes prime importance. In this phase, it is necessary to analyse the magnitude of result that is selected as a dose for trials.
An important factor underlying Clinical Trial Phase 1 includes the research that results in a generalised way for extrapolating the results. In this case, the aim is not in choosing a treatment for any individual patient. The focus is not on the outcome of clinical research trial but the intention is to get generalised information detailing the concept of clinical trial especially of the first phase, which is a consequential approach. This phase is a utilitarian approach seeking generalised knowledge. Phase 1 patients seldom are capable of providing informed and valid consent as they do not consent for their own but for collection of general information. But, this is vulnerable and is not a valid ground for objecting patient enrolment.
However, terminally ill patients are vulnerable and can be manipulated for being treated under Clinical Trial Phase 1. It is suggested to enrol patients in this prominent phase because in this kind of clinical trial, generally no harm is caused to the patient and it is beneficial than some other interventions. The patients of this specific phase along with their health volunteers often face some identical issues while participating in this phase of research. So, it becomes essential to redefine the relationship between patient and doctor for better progress in a clinical research.