· Problem statement: If the chosen health problem is significant enough to research on.
If the chosen study could have broader applications of useful research.
· Relevance of context: If any pre-existing researches that showed the need for further analysis. (Regulatory Affairs Courses)
· Validity of information: If the study is analyzed enough to draw gainful insights from the results.
· Practicality of the study: If the study has broader application or is specific to a certain disease.
· Emphasis on patients: If the study’s focus is aligned with the priorities of patients and not any physician or institution.
· Cost effective: If the expenditure on the study was worthy enough or not.
If the study has any outliers that could lead to rejection and thus loss of money.
· Viability: If the relevance of study is possible to be carried out in real conditions.
· Assurance: If the integrity of the study would be verified and would be free of biases.
The Clinical Research is further categorized into two main types — clinical trials (interventional studies) and observational studies.
Clinical trials
During clinical trials, a different therapy is planned as researcher’s protocol and given to the participants. They are prescribed certain medications, surgeries along with dietary changes as a part of treatment. In clinical trials, an inactive placebo is designed as medical strategy by comparing it with already available medicine/drug. Participants could also be told to have no medical or surgical intervention if needed. Later, the given treatments of specific patients are evaluated and analyzed understand their effectiveness and safety. For instance, a certain medication or other form of treatment is given to people with high blood pressure. The goal is to determine if their blood pressure decreases after receiving the treatment. There are occasions when the word “phases” is used to describe clinical trials used in medication development. The Food and Drug Administration (FDA) is responsible for the specification of these phases.
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Observational study
In an observational study, a set of protocols or strategy is decided for evaluating the patient groups’ health status. Participants are given interventions as a part of their usual medical care either in the form of drugs, equipment or surgery. But, the investigator does not randomly assign individuals to particular interventions (unlike clinical trial). For instance, researchers may try to find out more about lifestyle changes that affect cardiac heath by monitoring a group of senior citizens.
