Protocol Development in Clinical Trials for Healthcare Management

Protocol Development in Clinical Trials for Healthcare Management

Swati Changdeo Jagdale (School of Pharmacy, Dr. Vishwanath Karad MIT World Peace University, Pune, India), Asawaree Anand Hable (MAEER's Maharashtra Institute of Pharmacy, Pune, India) and Anuruddha R. Chabukswar (School of Pharmacy, Dr. Vishwanath Karad MIT World Peace University, Pune, India)
Copyright: © 2021 |Pages: 18
DOI: 10.4018/978-1-7998-3479-3.ch124

Abstract

Clinical trial is a part of clinical research. It is a systematic experimental biomedical study. They are carried out to evaluate the effectiveness and safety of medications or medical devices or biologics. Trials are conducted to check safety and efficacy of new drug. It includes four phases as phase I, II, III, and IV. The study is carried out according to study protocol and standard operating procedures as per good clinical practices guidelines. The study protocol is developed by the researchers and approved by an independent committee called as Institutional Review Board. Protocol is a roadmap for team of healthcare professionals involved in investigation work. It should explain the significance of research trial, location, detail procedure, methods, activities, time allotment, financial estimate and any other information required. The content of protocol are title, objective, background, eligibility criteria, study methodology, risks or adverse effects, benefits, alternative treatment, data collection, statistical treatment, regulatory guidance, and other information.
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Clinical Research

Clinical trial is a research study, also called as clinical study. This study includes testing of new treatments or modification of existing therapy on human volunteers. The study determines the safety and efficacy of drug therapy for commercial use in various populations. They provide better way to screen, diagnose, prevent and cure a disease. Clinical trials are carried out for the new treatments under research whose outcome is unknown and previously not studied. Clinical trials follow a pre-designed plan for health-related research studies in human. Clinical trial is defined as the systematic study of new drugs in human to generate data for discovering and verifying the clinical, pharmacological and adverse effects with objective of determination of safety and efficacy of the new treatment. (Bajpai, 2013;Manavalan and Sinfield, 2017)

Research team in clinical trial includes doctors, nurses and health care professionals. They monitor participants and do their health checkups regularly. The research team works with participants in all types of trials. Role of participants or volunteers is more active in clinical research. They are important as they get new therapies to treat a disease before these are available for commercial use. For the safety of volunteers or participants involved in clinical research, there are guidelines for appropriate selection. After qualifying the eligibility criteria they can take part in clinical trial. (Crisp and Burke, 2005;Gandhi, 2011).

The plan with all details of the clinical trial is called as research protocol. Every study has different protocol depending upon type of trial. If the protocol is carefully followed during the clinical trial process then trial becomes more successful. Design of trial plan takes care of safety of participants. So, the research protocol should be designed carefully. The protocol describes all the details of the study.(Thorat, et. al., 2010). Figure 1 represents general flow for study of the drug throughout clinical research.

Figure 1.

Representation of clinical research and phases of clinical trial(Source: Thorat, et. al, 2010)

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Clinical Trial Phases

Preclinical trial study is done on laboratory animals before testing the drug on human. This testing determines safety of drug for human consumption in disease treatment. After completion of preclinical study, filing of an investigational new drug application (IND) must be done. (Thorat, et. al., 2010; Gandhi, 2011).

Key Terms in this Chapter

Clinical Research: This research is carried out to ascertain the safety, efficacy and effectiveness of the new drug product or new therapy for treatment of a specific disease in human.

Study Protocol: This document provides details of each step to be carried out in clinical research.

Sponsor: The sponsor can be a person or organization which provides all financial assistance to carry out a clinical trial.

Pre-Clinical Study: This is part of clinical research in which the safety of the new drug or treatment is carried out on experimental animals.

Clinical Trial: This research is experiments carried out in human, observations are recorded to determine the safety and efficacy of the therapy.

Protocol Deviations: The non-compliance to the protocol is protocol deviations but this does not significantly affect the risks and benefits of the clinical trial.

Investigator: The individuals who actually carry out and monitor the clinical trial.

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