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). phase IV Analytics methods studies may be required by sponsoring companies, when detecting a new drug market or testing the drug interactions with other drugs, and also by regulatory authorities (4). The safety surveillance, which is a very important part of a comprehensive post-marketing program, investigates drugs long term effects in a large number of people (1) (3). The aims of the post-marketing safety surveillances program are to examine and quantify new drug safety issues, to recognize risk factors of product marketing, and to control medication use patterns (3). If undesirable effects are noticed In this forth phase of trial, the drug might get withdrawn from the market. Figure: Methods of Suveillance Studies: There are four different types of studies that are mostly conducted to determine drug effects including; controlled clinical trails, spontaneous reports, cohort studies, and case control studies (5). Controlled clinical trails, which work closely with therapy and study group, minimize bias via specific methods such as: double blinding and randomization. This trial also monitor patients during the study duration. The contro... ... middle of paper ... ...80). 8- Mann, J. I., “Principles and Pitfalls in Drug Epidemiology,” in Monitoring for Drug Salkty, W. H. W. Inman (cd. ) (Philadelphia: J.B. Lippincott Co., 1980), 9- Remington, R. D., “Post-Marketing Drug Surveillance: A Comparison of Methods, ” Amer. J. Pharmacy 150:72, 1978. 10- Wardell, W. M., et al., “Postmarketing Surveillance of New Drugs: I. Review of Objectives and Methodology, ” J. CZin. Pharmacol. 19:85, 1979. 11- Postmarketing Surveillance of Prescription Drugs, November 1982 NTIS order #PB83-173625 12-The US Postmarketing Surveillance Study of Adult Osteosarcoma and Teriparatide: Study Design and Findings From the First 7 Years Elizabeth B Andrews, Alicia W Gilsenan, [...], and Daniel Masica 13- Post-Marketing Surveillance of rotavirus vaccine safety, Department of Immunization, vaccines, and Biologicals , March 2009.
The analysis is therefore one of the most effective methods of ensuring that each drug being prescribed to patients is safe. It also ensures that all drug components are understood in terms of their structure and chemical behavior. This understanding is very important in the manufacture of drugs and other pharmaceutical products.
First, when viewing DTC prescription drug ads, the public cannot understand the wording used to describe the drugs. Because of this, the producers of these ads are able to manipulate the drug’s effects to sway people into buying them. According to the article, 74% of surveyed doctors believe that the benefits expressed in prescription drug ads are embellished (paragraph 5). This inaccurate information causes patients to be misinformed as to the effects of the drug. Opposingly, 48% of doctors state that these ads inform and educate patients about DTC prescription drugs (paragraph 6). The percentages
The article’s information is presented with the goal of informing a reader on vaccines. The evidence is statistical and unbiased, showing data on both side effects and disease prevention, providing rates of death and serious illness from both sides. This evidence is sourced from a variety of medical organizations and seems reliable, logical, and easily understood, no language that would inspire an emotional response is used. The validity of studies is not mentioned in the article, but it does encourage readers to investigate further to help make a decision. The article allows a reader to analyze the presented evidence and come to their own
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.
While both cancer treatment and chemoprevention trials involve agents that can cause side effects in individuals, chemoprevention trials diverge from treatment trials with respect to the unit of potential benefit. In trials of cancer treatment or of “adjuvant therapies” (secondary prevention), subjects either hav...
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].
Wright, A., FebloWitz, J., Phansalkar, S., Liu, J., Wilcox, A., Keohane, C., … Bates, D. (2012). Preventability of adverse drug events involving multiple drugs using publicly available clinical decision support tools. American Journal of Health-System Pharmacy, 69, 221-227.
The FDA offers programs called clinical trials where a new drug is tested in patients, but the patients are only considered when every other treatment option has been exhausted (Falloon 4). Clinical trials are also selective, as only people of certain ages, sexes, and types or stages of disease with previous treatment are even considered to participate (Inside Clinical Trials 2). This causes almost ninety seven percent of terminally ill patients to be ineligible for a trial (Corieri 3). Also, clinical trials only allow a small amount of people, with only between 20 and 80 people chosen to participate in phase 1 (Inside Clinical Trials 2). With this margin, even ...
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
O'Brien (2013) defines RCT as a research technique that has been through the ages. It first was applied in medical studies. Today, it is a quantitative method widely used in clinical trials where participants answer or confirm a research question. Clinical trials that are designed with RCT in a medical context focus on prioritizing the protecting of human participants with the aid of ethical criteria; however, at the discretion of the researcher (O'Brien, 2013).
Gandey, Allison. “New National Drug Control Policy Includes More Prescription Monitoring.” Medscape Today. Web MD, 7 May 2010. Web. 24 Jan. 2012. .
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
...s affect a person’s response to drugs) data are needed. This information will help identify medications that benefit populations in all parts of the world and will better enable local regulators to interpret the relevance of trial results from other countries for their target populations. In the long-term, solutions to problems arising from outsourcing clinical trials will require input from collaborators in academia, industry, and regulatory agencies around the world. The future of the pharmaceutical industries depends on addressing these issues. The ethical and scientific integrity of clinical research globally must be ensured, promote organization and uniformity in the field of international research, and provide information about the benefits and risks of new drugs in the populations and environments in which patients live, wherever they may be.
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. Second is an observational study in which individuals are observed and their outcomes are measured by the investigators.
Researchers work hard to eliminate bias from outcomes through approaches that diminish subjectivity and modification from unknown sources. Randomization, use of well-matched controls, and blinding of analysts and researchers are some ways to try to a...