Clinical Trials and Clinical Research: A Comprehensive Review

Abstract

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Incorporating Dermatologic Clinical Research Into Private Practice: A Review

“…A starting point for incorporating clinical research is defining what clinical research is in a dermatologic setting. Clinical research is a broad term describing human research and can encompass a vast array of research, ranging from studying risk factors and disease pathophysiology to clinical drug trials, which study the efficacy and safety profile of drug treatment [ 2 ]. From a larger framework, clinical research can be divided into two categories: observational studies and experimental studies [ 6 ].…”

“…For the purposes of this review, we will focus on the process of starting clinical drug trials in the context of a private dermatologic practice. There are different phases in clinical drug trials: phase 0 (exploratory study); phase I, phase Ia and phase Ib (non-therapeutic trial); phase II, phase IIa, and phase IIb (exploratory trial); phase III (therapeutic confirmatory trial); and phase IV (post-approval study) [ 2 ]. Private practices can be a part of any phase of the drug trial process depending on their resources and prior experiences.…”

“…In the case of industry-sponsored research, the investigator is the provider responsible for initiating clinical research [ 2 ]. The sponsor in the case of industry-sponsored research is the pharmaceutical company or organization providing funds to conduct the research [ 2 ]. The sponsor is the entity that takes responsibility for the clinical trials.…”

“…Over time, clinical research has expanded into the extensive field that we see today, equipped with safeguards, rules, and guidelines to protect both the patient populations and the integrity of the datasets being studied [ 1 ]. Clinical research is a broad term describing medical research that can involve a large array of interventional and non-interventional research types [ 2 ]. Clinical research has facilitated major advancements in medicine by creating breakthroughs in disease understanding, management, monitoring, and treatment [ 1 - 2 ].…”

“…Clinical research is a broad term describing medical research that can involve a large array of interventional and non-interventional research types [ 2 ]. Clinical research has facilitated major advancements in medicine by creating breakthroughs in disease understanding, management, monitoring, and treatment [ 1 - 2 ]. Clinical drug trials are a form of research that has had a positive impact on medicine as a whole [ 1 - 2 ].…”