Kandi Venkataramana, Vadakedath Sabitha
Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND.
Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND.
Cureus. 2023 Feb 16;15(2):e35077. doi: 10.7759/cureus.35077. eCollection 2023 Feb.
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.
临床研究是用于描述医学研究的另一种术语。临床研究涉及人,通常是为了评估治疗药物、医疗/外科手术或器械作为治疗和患者管理一部分的疗效而开展。此外,任何评估疾病各个方面(如症状、危险因素和病理生理学等)的研究都可称为临床研究。然而,临床试验是评估治疗药物/器械在疾病管理、控制和预防方面潜力的研究。鉴于传染病和非传染病发病率不断上升,尤其是在2019冠状病毒病(COVID-19)对全球公共卫生产生影响之后,对临床研究的重视显得极为重要。临床研究知识将有助于发现药物、器械和疫苗,从而提高应对突发公共卫生事件的准备能力。因此,在本综述中,我们全面描述了临床研究的关键要素,包括临床试验阶段、临床试验的类型和设计、试验操作、审核与管理以及伦理问题。