Human Drug Trials: Pros, Cons, Ethical Issues, and Response Plan

Running head: REPORT
Human drug trials (pharmacological research)
Name of the Student
Student No.
Unit: NIT6130 – Introduction to Research
Submission Due: 5pm, Friday, Week 5
Name of the University
Author Note

1REPORT
Table of Contents
Introduction................................................................................................................................2
Research background.................................................................................................................2
Pros and cons of research...........................................................................................................3
Ethical issues, integrity, safety issues and risks.........................................................................4
Response plan.............................................................................................................................7
Conclusion..................................................................................................................................8
References..................................................................................................................................9

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Introduction
A clinical trial refers to research studies that explore the safety and effectiveness of
certain treatment, medical strategy or device, for humans. These trials might also help in the
identification of certain medical approaches that have been found to work best for a group of
disorders or illness among people (Pocock 2013). In other words, clinical drug trials have the
potential of producing best available data that guides the process of clinical decision making.
They are piloted only after obtaining an approval from the ethics committee or health
authority, who are responsible for inspecting the trial’s risk:benefit ratio.
Research background
Drug testing or device testing usually begins by the conduction of extensive
laboratory research that most often involves several years of testing in human and animal
cells. After obtaining success in the laboratory, the data are sent by the researches to the FDA
(Food and Drug Administration), with the aim of gaining a sanction for continuing research
and subsequently testing it on humans. Following an approval, the human trial of
experimental drugs is most commonly conducted in four stages. Each stage forms a separate
trial, after completion of which, the researchers are expected to submit the extracted data, in
order to gain FDA approval, before beginning the next phase (Junod 2014). Phase I studies
focus on assessing the safety of a drug and get completed in several months. The primary aim
of the phase I is to explore the impacts of the drug on humans and its absorption, metabolism,
and excretion. The efficacy of the drug is tested in phase II that involves an experimental
group and a control group, in order to provide a comparative information on the safety of the
drug (Piantadosi 2017). Randomised and blind trials are conducted in thousands of patients in
phase III for gaining a deeper understanding on the drug effectiveness, followed by Post
Marketing Surveillance Trials in phase IV, after obtaining approval for consumer sale of the

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drug. Thus, these prospective biomedical researches on human volunteers provide answers to
specific questions on the intervention or novel drug and/or vaccine.
Pros and cons of research
The field of medicine is constantly evolving and dynamic. Some of the major advantages
of human drug trials are listed below:
 Helps in gaining access to a novel and possibly more operational and harmless
treatment, than what is presently available to all people.
 Provides access to certain treatment methods that have been identified to pose less
severe or fewer side effects than those of drugs that are used in current practice.
 Helping others by providing assistance to the pharmaceutical companies in obtaining
the necessary data that is essential to gain an approval for the drug in question (Smith
and Rawlins 2013).
 Even when the drug fails to stand true to the hypothesis, these trials also provide
significant information and guide the researchers on the rewarding treatment
approaches.
 The costs of the drug, medical professional fees and costs of all tests are free of
charge. This particularly helps people who cannot afford the medical care.
 The participants also get reimbursed for travel-related expenses, in addition to
obtaining modest stipend.
 The group of participants might be one of the few patients to gain benefit from the
intervention (Lurie and Morgan 2013).
 They are provided with the opportunity to play an active role in their own healthcare.
However, the major disadvantages of human drug trials are as follows:
 Fear of adverse impacts of the novel drug on health outcomes