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What is Clinical Research? Human subjects research is research which studies humans, as opposed to animals, atoms, or asteroids. Clinical research refers to the subset of human subjects research which focuses on interventions to improve human health and well-being.

The present analysis focuses on research that is designed to improve human health and well-being by identifying better methods to treat, cure or prevent illness. This focus on treating, curing and preventing illness is All of this to bracket the question of whether research on enhancements qualifies as clinical research.

Such research has the potential to improve well-being, allowing us to remember more and worry less, without identifying methods to address illness. We shall also bracket the question of whether quality improvement and quality assurance projects qualify as clinical research. To briefly consider the type of research at the heart of this debate, consider a hospital which proposes to evaluate the impact of checklists on the quality of patient care.

Half the nurses in the hospital are told to continue to provide care as usual; the other half are provided with a checklist and instructed to mechanically check off each item as they complete it when caring for their patients. The question of whether this activity constitutes clinical research is of theoretical interest for clarifying the precise boundaries of the concept.


Should we say that this is not clinical research because the checklist is used by the nurses, not administered to the patients? Or should we say this is clinical research because it involves the systematic testing of a hypothesis which is answered by collecting data on patient outcomes?

While clinical medicine is enormously better than it was or even 50 years ago, All of this remain many diseases against which current clinical medicine offers an inadequate response.

To name just a few, malaria kills over a million people, mostly children, every year; chronic diseases, chief among them heart disease and stroke, kill millions each year, and there currently are no effective treatments for Alzheimer disease. The social value of clinical research lies in its ability to collect information that might be useful to identifying improved methods to treat these conditions.

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Yet, it is the rare clinical research study which definitively establishes that a particular method is effective and safe for treating, curing or preventing some illness.

The success of specific research studies more commonly lies in the gathering of information needed to inform future studies. Prior to establishing the efficacy of an experimental treatment for a given condition, researchers typically need to identify the cause of the condition, possible mechanisms for treating it, a safe and effective dose, and ways of testing whether the drug is having an effect on the disease.

The process of testing potential new treatments can take years, and is standardly divided into phases. Formalized phase 0 studies are a relatively recent phenomenon involving the testing of interventions and methods which might be used in later phase studies.

A phase 0 study might be designed to determine the mechanism of action of a particular drug and evaluate different ways to administer it.

Phase 1 studies are the earliest tests of a new intervention and are conducted in small numbers of individuals. Phase 1 studies are designed to evaluate the pharmacokinetics and pharmacodynamics of new treatments, essentially evaluating how the drug influences the human body and how the human body influences the drug.

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Phase 1 studies also evaluate the risks of the treatment and attempt to identify an appropriate dose to be used in subsequent phase 2 studies. Phase 1 studies pose risks and frequently offer little if any potential for clinical benefit to subjects.

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As a result, a significant amount of the ethical concern over clinical research focuses on phase 1 studies. If phase 1 testing is successful, potential new treatments go on to larger phase 2 studies which are designed to further assess risks and also to evaluate whether there is any evidence that the treatment might be beneficial.

Successful phase 2 studies are followed by phase 3 studies which involve hundreds, sometimes thousands of patients.

Phase 3 studies are designed to provide a rigorous test of the efficacy of a treatment and frequently involve randomization of subjects to the new treatment or a control, which might be standard existing treatment or a placebo.

Finally, post-marketing or phase 4 studies evaluate the use of interventions in clinical practice. Clinical trials of experimental treatments typically include purely research procedures, such as blood draws, imaging scans, or biopsies, that are performed to collect data regarding the treatment under study.

Analysis of the ethics of clinical research thus requires evaluation of three related risk-benefit profiles: Potential new treatments sometimes are in the ex ante interests of research subjects.

Experimental interventions sometimes pose net risks. A first in human trial of an experimental treatment might involve a single dose to see whether humans can tolerate it. And it might occur in healthy individuals who have no need of treatment. These studies pose risks to subjects and offer essentially no chance for clinical benefit.

For example, a biopsy that is used to collect research data may disclose a previously unidentified and treatable condition. The chance for such benefit, albeit real, is typically so remote that it is not sufficient to compensate for the risks of the procedure. Whether a study as a whole poses net risks depends on whether the potential benefits of the experimental intervention compensate for its risks plus the net risks of the research procedures included in the study.

Clinical research which poses net risks raises important ethical concern. Net-risk studies raise concern that subjects are being used as mere means to collect information to benefit future patients. Research procedures that pose net risks may seem to raise less concern when they are embedded within a study which offers a favorable risk-benefit profile overall.

Yet, since these procedures pose net risks, and since the investigators could provide subjects with the new potential treatment alone, they require justification.All Calm Clinic content is medically reviewed or fact checked to ensure as much factual accuracy as possible.

We have strict sourcing guidelines and only link to reputable media sites, academic research institutions and, whenever possible, medically peer reviewed studies. Get auto insurance quotes at You're In Good Hands With Allstate. Allstate also offers insurance for your home, motorcycle, RV, as well as financial products such as permanent and term life insurance.

After all, we are seeking the ethical approach or policy with respect to clinical research. The problem, then, is that the answer we get in this case may depend significantly on which ethical constraints are built into the system, rendering the approach question begging.

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