The first steps in clinical research involve identifying a biological problem that is clinically relevant, identifying the appropriate clinical test and the relevant patient demographics, and then defining appropriate criteria for enrollment and inclusion into the study.
In this article, we discuss the three common types of criteria used when screening, recruiting and evaluating potential participants in clinical trials. The first of the three steps in clinical trials is to identify a biological problem that is clinically relevant and clinically feasible.
The first step involves conducting a thorough review of the scientific literature, identifying potential biological targets and/or symptoms for a treatment or a disease, determining the best method for addressing these problems, and finally, choosing the appropriate clinical test to determine whether or not the candidate has the necessary clinical signs and symptoms to be included in the clinical trial.
This step includes multiple steps depending on the specific disorder and the type of clinical trial. The second step in the screening is to create a definition of the biological system or target using a definition based on the most recent scientific literature, clinical studies, and other data gathered from previous studies and research.
The goal is to provide the best possible definition to the investigators. The third step is the selection of the candidate by selecting the candidate who meets the pre-defined criteria, including a high probability of being enrolled, is a suitable candidate for enrollment, and can follow the study protocol.
The fourth step involves the development of a physical examination and laboratory tests designed to diagnose the biological condition of the candidate. When evaluating the biological validity of the candidate, the third step of screening for biological diagnosis must be combined with laboratory tests to exclude the possibility of false-positive results.
The fifth step in screening for a potential participant in a clinical trial is the evaluation of the candidate. The clinical investigator should have an idea of the clinical relevance of each study subject and what medical conditions and disorders he or she expects to have participated in the clinical trial and how many such subjects will be involved in the study.
The investigator should also have an idea of the number of potential subjects to be enrolled in the clinical trial, which will determine the number of clinical trials. The sixth step in screening for a possible participant in a clinical trial is the enrollment into the clinical trial.
Once the clinical investigators have determined a probable enrollment, they determine which subjects will be enrolled in the clinical trial.
They need to make sure the subjects are eligible for the clinical trial such as a) meeting the criteria for enrollment b) a history of a medical condition such as hypertension, diabetes, heart disease, and cancer, c), and that the subjects are eligible for the study protocol and d) if the subjects are capable of participating and willing to participate.
The investigator also needs to check whether the subjects meet the clinical eligibility requirements. The last step of screening in a clinical trial is recruiting and evaluating the subjects involved in the clinical trial.
As mentioned above, there are multiple steps involved but typically these involve a combination of multiple clinical trials and the use of criteria to determine if the subjects are suitable candidates for clinical trials.
These six steps in screening and recruitment are common in all clinical trials, however, in some research, the procedures will differ depending on the type of clinical trial and the subjects participating.
In addition, these steps can vary among different medical disciplines and research centers, and therefore it is important to discuss these steps with your colleagues.