Control in a Clinical Trial Essay

Control in a Clinical Trial Essay

Length: 1532 words (4.4 double-spaced pages)

Rating: Powerful Essays

Open Document

Essay Preview

The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained will be clear and non-ambiguous [‎1].
The use of placebo controlled study has been controversial since it was first introduced (c 1931). In this study, distilled water was used as a control when Sanocrysin was tested as a possible treatment for tuberculosis. The use of placebo control in clinical trials becomes controversial when there are other effective treatments available. It is undeniable that the use of placebo control can be beneficial in giving a strong clinically relevant data [‎2].
The recent version of the declaration of Helsinki states that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances [‎3]:
• The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
• Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
Clinicians, however, have been justifying the use of plac...

... middle of paper ...

... in clinical trials. This decision will benefit pharmaceutical companies and CROs since it allows them to use placebo control even when a standard treatment is available [‎10 & ‎11].
As Epstein (2007) alluded that pharmaceutical companies could be exploiting the poor infrastructure, deferential patient population and the lack of regulatory body in developing countries to conduct clinical trials that are ethically unacceptable [‎12].
This paper, by no means, is suggesting to completely avoid a placebo controlled studies. However, it points out that special care and thoughtful considerations need to be taken when planning a placebo controlled study especially where there are existing treatments. In addition, when conducting clinical trials in developing countries, patients should be given equal rights and opportunities as their counterparts in the developed countries.

Need Writing Help?

Get feedback on grammar, clarity, concision and logic instantly.

Check your paper »

Global Phase Iv Clinical Studies : Challenges And Perspectives Essay

- Global phase IV clinical studies: challenges and perspectives The phase IV clinical trial also called as a post marketing surveillance (PMS) or late phase clinical trial and it is a very different in design than earlier conducted phase I to phase III studies. Each PMS study considered as a phase IV study but is not true that each and every one phase IV study is considered as post-marketing surveillance (PMS) study (Suvarna, 2010). Phase IV study is as important as phase I to phase III of drug progress....   [tags: Clinical trial, Pharmaceutical industry]

Powerful Essays
1977 words (5.6 pages)

Essay Information Technology in Clinical Research

- Definition of clinical research and clinical trial In World Health Organization’s definition, “for the purpose of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcome” (WHO, 2014). National Institute of Health specified the differences between clinical research and clinical trials. “Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue....   [tags: clinical trial, bio-informatics, patient outcome]

Powerful Essays
1991 words (5.7 pages)

Essay The Pharmaceutical Drug Manufacturers Are Moving Toward Adaptive Design

- The pharmaceutical drug manufacturers are moving towards adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design gives greater benefit compare to traditional drug trial design for success of new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in clinical trial. Adaptive trial design allows researchers modification in the clinical trial and statistical procedure of the clinical trial after commencement of a clinical trial without harming trial’s validity and integrity....   [tags: Clinical trial, Pharmaceutical industry]

Powerful Essays
1389 words (4 pages)

Adaptive Design Of The Pharmaceutical Drugs Manufacturers Essay

- Adaptive Design The pharmaceutical drugs manufacturers are moving towards adaptive design in clinical trial as per the U.S.FDA guidance. The adaptive trial design is giving great benefit than a traditional drug trial design through the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in clinical trial. Adaptive trial design allows researchers modification in the clinical trial and/or statistical procedure of the clinical trial after initiation of clinical trial without harming trial validity and integrity....   [tags: Clinical trial, Pharmaceutical industry]

Powerful Essays
1565 words (4.5 pages)

Ebola Vaccine Raise Ethical Issues, Randomized Studies May Offer Faster Answers

- The article that I have selected for short paper #1 was taken from Science magazine, Volume 346, Issue 6207 and is titled; “Ebola vaccine raise ethical issues, Randomized studies may offer faster answers”. According to the Centers for Disease Control and Prevention (CDC), the Ebola virus is a rare and deadly disease caused by infection with one of the Ebola virus strains . The virus was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo1. The key message that the article is trying to convey throughout pertains to the ethical considerations that are being looked at and addressed while designing the human clinical trials for the Ebola vaccine....   [tags: Clinical trial, Pharmacology]

Powerful Essays
879 words (2.5 pages)

Central Line Clinical Practice Guideline and Rational Essay

- Central Line Clinical Practice Guideline & Rational Central venous catheters (CVCs) are frequently used in intensive care units (ICUs) for a number of reasons (measure central venous pressure, when peripheral veins are unable to be accessed, administration of medications/therapies and aspiration of blood samples) (Conroy, 2006, p. 98). Patients in this environment already have an increased risk of infection because of their treatments. Patient treatments commonly involve invasive devices or interventions (major surgery), antibiotic therapy (raises the risk of bacterial resistance) while steroid, chemotherapy and radiation therapy all suppress the immune system (Hatler, Hebden, Kaler, & Zack,...   [tags: Clinical Practice Guidelines]

Powerful Essays
2337 words (6.7 pages)

The Role of Post-Marketing Surveillance in Clinical Trial Essay

- The Role of Post marketing Surveillance in Clinical Trial Clinical trials containing new drugs are categorized into essential four phases (1). The drug development procedures are usually performed through the all phases over several years (1). The drug will be approved for use in the general population, if it successfully exceeds through the first three phases; I, II, and III. The fourth phase -IV- is called Post marketing Surveillance and/or Post approval studies (2). Postmarketing Surveillance Trial provides the safety surveillance (Pharmacovigilance) (3)....   [tags: new drug process]

Powerful Essays
896 words (2.6 pages)

Essay about Clinical Trials are the Gateway to Medical Treatment

- Introduction Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints, a control group, randomly allocated subjects into a treatment group and a control group, blinded both subject groups and investigators, sufficient sample size, and an approved independent ethics com...   [tags: placebo, control, outcomes]

Powerful Essays
926 words (2.6 pages)

Essay on The Birth Control and Abortion Debate

-      Did you know that in the America there are four thousand abortions a day. The second highest rate in the world. In America we have the right between having an abortion or taking the responsibility to use birth control. In the twentieth century technological advantages has brought American to change their point of view in a major legal dispute.      Abortion is the conclusion of a pregnancy, the ejection of the embryo or fetus. In the beginning of the 1800's abortion was permitted until the mid 1800's it became a subject in which was a strictly legal regulation ....   [tags: Contraceptives, Birth Control Essays]

Free Essays
1405 words (4 pages)

Clinical trials Essay examples

- Introduction Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured....   [tags: interventional studies, observational studies]

Powerful Essays
652 words (1.9 pages)