...contracted by a sponsor or client to perform several functions and duties related to clinical trials. (Kaluzny & McLaughlin, 2006, p. 319) The clinical trials are designed to obtain regulatory approval to market new pharmaceutical or biotechnology products. (Kaluzny & McLaughlin, 2006, p. 319) The services they perform for such clients as pharmaceutical companies include: “consulting and advice related to the design of drug development programs to labor-intensive services that are part of the drug development process; these include clinical monitoring of investigational sites, data management and statistical analysis, and presentations of regulatory submissions for review by regulatory agencies such as the U.S. Food and Drug Administration”. (Kaluzny & McLaughlin, 2006, p. 319) The FDA in the United States clearly mandate practices to protect the public’s health by implementing laws, regulations, and guidelines that provide oversight of the drug development process. (Kaluzny & McLaughlin, 2006, p. 322) The FDA requires the CRO to complete an IND or investigational New Drug application. “The pharmaceutical industry sometimes seeks advice from the FDA prior to submission of an IND”. (The FDA’s Drug Review Process, 2011) Throughout the whole process the FDA participates or more like regulates these clinical trials. The CROs as well as the...
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... FDA Approval process for Clinical Trials If you, or someone you loved, were diagnosed with a terminal disease, would you chance using a non-FDA approved medication to increase your life expectancy? Many pharmaceutical companies have the medication that could save countless lives, but the FDA clinical trials for these medicines are problematic for enrollment, and thousands of patients are often turned down. New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug to a smaller group...
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...QUESTION 1: According to 21 CFR 314.80, “Any adverse drug experience that is not listed in the current labelling for the drug product”. Since the patient is hospitalized and the side effect is not listed in the package insert this is considered as unexpected serious adverse event. As the product used is an approved product, as per 21 CFR 313.80, this case should be reported to FDA within 15 calendar days of the initial receipt. Reference: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80 QUESTION 2: Title 21 of the Code of Federal Regulations (CFR) Section 312.42 describes a clinical hold as a clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug; patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety....
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...June 9-13, 2012 – Baltimore, Maryland 2012 ASHP Summer Meeting Management Case Study Submission and Format Guidelines Management Case Studies are 20-minute platform presentations followed by a 10-minute question and answer period. ASHP is seeking management case studies in specific topic areas: • Informatics • Leadership / Administration • Medication Safety • Clinical Conundrums This document will assist you in the preparation of your submission for a Management Case Study (MCS). The number of accepted management case studies will be limited and it is anticipated to be a highly competitive process. Each primary author is allowed only one submission. Due to ACPE Standards regarding active learning, a standard format will be required for final slide presentations which will utilize the learning objectives and self-assessment questions that you prepare for your submission. Thank you for your interest in presenting at the 2012 ASHP Summer Meeting! For assistance with preparing learning objectives and self-assessment questions, visit: http://www.ashp.org/menu/Education/OnlinePrograms.aspx and select ‘Education’ from the drop-down menu What is a Management Case Study? Introduction • The case study method was pioneered by the Harvard Business School in the early 1900s and still stands as a popular and effective teaching strategy in business education. • • The case method relies on information about people and events in a true-to-life situation that represents a problem to be analyzed...
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...development of new drugs and new research to use these drugs effectively. Drug companies run a substantial amount of tests before finding one that works effectively through all the different phases of testing. The process of drug approval is controlled in most countries by a governmental regulatory agency. In the U.S., the Food and Drug Administration (FDA) governs this process. The FDA requires the following phases to be achieved successfully before a drug can be sent to market, preclinical testing, investigational new drug application, phases I clinical trials, phase II clinical trials, phases III clinical trials, new drug application, and post marketing studies. A preclinical trial is the testing that begins before human testing can be conducted and which important feasibility, iterative testing and drug safety data is collected. This type of data research allows scientists to come up with a safe dosage for humans; typically this is done with animal testing. These tests can usually take around 3 to 4 years, before moving on to the next step. If there are no adverse effects then the drug moves on to the next step, which is investigational new drug application (IND). The pharmaceutical company files an IND with the FDA to begin testing the drug in people. The IND becomes effective if the FDA does not disapprove it within 30 days (medicine.net, 1999). The IND must include the following information: the results of previous experiments; how, where and by whom the new studies will...
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...You correctly answered 1 of 5 and received 1 of 5 possible points. Scroll down to review the quiz questions and the explanation of the answers. Question 1 Question : An elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? Your answer : The investigator can go ahead and enroll the man without a signed consent. Correct Answer : Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. Comment : The IRB will not provide a waiver of consent under these circumstances and the man should not be excluded from the study simply because his legally authorized representative is temporarily unavailable to sign in person. Verbal approval does not satisfy the FDA requirement at 21 CFR 56.109(c) of signed informed consent document. When obtaining consent from a legally authorized representative (LAR) who is not able to provide signed consent in person, it is acceptable to send the informed consent...
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...Basic Institutional Review Board (IRB) Regulations and Review Process Content Authors Ada Sue Selwitz, M.A. The University of Kentucky Norma Epley, M.S. East Carolina University Janelle Erickson, MPH Institute for Systems Biology Introduction The purpose of this module is to provide a basic understanding of the human subject protection regulations that govern the participation of human volunteers in research in the United States. Learning Objectives By end of the module you should be able to: Describe the role, authority, and composition of the IRB. List the IRB requirements for conducting research involving human subjects. Describe the types of IRB review. Describe the process of working with the IRB. Identify other regulations and regulatory groups that require compliance based on the type of research being conducted. IRB Role, Authority, and Composition The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. To clarify when IRB review is required, let's define some...
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... * My Reports * Support * Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent Content Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends. There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to research subjects...
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...subject protection regulations that govern the participation of human volunteers in research in the United States. Learning Objectives By end of the module you should be able to: * Describe the role, authority, and composition of the IRB. * List the IRB requirements for conducting research involving human subjects. * Describe the types of IRB review. * Describe the process of working with the IRB. * Identify other regulations and regulatory groups that require compliance based on the type of research being conducted. IRB Role, Authority, and Composition The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. To clarify when IRB review is required, let's define some terms: * Research: Federal regulations define research as: "a systematic investigation... designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)] If an investigator is unclear about whether a planned activity is research, the investigator should contact his/her IRB office. * * Human Subjects:...
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...Pharmaceuticals industry has a key role in manufacturing and developing new vaccines and drugs with an objective to improve life and prevention of diseases. Pharmaceutical industry have involvement in research and development, dealing in research and generation of new drugs, bulk manufacturing involving production of already existed drugs and in marketing. In spite of the fact that pharmaceutical industry is subjected to high risk and challenging business conditions as compared to any other industry. It has made tremendous contribution in improving global health. (IFPMA, 2012) “ Pharmaceutical industry spends more on research and development, relative to its sales revenue, than almost any other industry in the United States. According to various estimates, the industries’ real spending on drug R&D has grown between threefold and six fold over the past 25 years and that rise has been closely matched by growth in drug sales”(CBO, 2006). The research and development based pharmaceutical industries invest billions of dollars for development of a single drug and on an average the annual spending by the pharmaceutical industry is five times greater than that of the aerospace and defense industries, 4.5 times more than that of the chemicals industry, and 2.5 times more than that of the software and computer services industry”(IFPMA, 2012). IMPACT ON GLOBAL HEALTH & ECONOMY Pharmaceuticals research and drugs showed a remarkable performance in improving life, increasing...
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...to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? Voluntary Consent Informed consent is considered an application of which Belmont principle? **** Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence & research records? For a minimum of three years after completion of the study. (May be required to keep them longer than 3 years) According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk &...
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...Research Paper BSHS/382 Define the scientific method. The scientific method has its foundation in a number of steps including research, observational analysis and establishing data-driven rulings. Tell how it relates to human services research. Based on substantiation research studies, medical treatments and newer drugs are not only sustained but also adapted and improved over time. Exclusive of scientific research, their formation and effectiveness regulation will not be achievable. What are the steps in the process of scientific inquiry? Why must each of these steps be included to support the scientific method? Provide a human services research example of the scientific method and identify each step within your example 1. The first step in executing a scientific examination for research in a given field of study. It ascends and takes a solid shape, once a trained researcher figures out that some evidence may be necessary but is missing, and to study such information, the researcher proposes the research setback. 2. Then occur, set up of variables and investigational conditions. 3. This is trailed by choosing or indiscriminately assigning qualified participants, under controlled laboratory and research conditions, to their individual experimental groups. 4. The variables are expended in distinctive variations, along with the treatment to be tested, and their endings are noted in a continuing...
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...Clinical Trials for New drugs. Therapies and Medical equipment The process for a new drug can take years and several stages to be approved by the FDA (Food and Drug Administration). Although most drugs are tested for specific kinds of diseases they might often have disappointing results for a specific disease but may have great results for another. The FDA has twelve stages of drug development and Review; these are important procedures before and after clinical trials. The twelve stages of drug development fall into the FDA’s four categories: pre-clinical, clinical, NDA (New Drug Application) review and post marketing. In the pre-clinical category there are two stages; animals tested and IND (Investigational New Drug) Application. The drug sponsor, companies/research institutions responsible for developing a drug, develops a new drug and seeks to have it approved by the FDA. Once the drug has been developed the sponsor has to test the new drug on animals for levels of toxicity, safety and efficacy of the drug. The sponsor then must submit an IND application and must include the results from animal testing. When the FDA approves of the new drug they make sure that it is completely safe to proceed and test on humans. In most cases drugs that have gone through the pre-clinical testing never actually make it to the human testing phase or are reviewed by the FDA. If the new drug is approved for human testing the research moves on to the clinical category, aka clinical...
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...The potential risk involved in bringing a new pharmaceutical drug to the market is huge. The actual timescale of the project is longer then a decade, and the success rate is around 1 in a 1000. In fact for every 1000 compounds that are produced only around 30 of these show any sort of promising result. Therefore introducing a new drug into the market does not simply involved one idea and one compound but in fact a complexed process of trial and error so to speak. After years of research on difference compounds have taken place the company can then progress to a stage know as the ‘preclinical stage’. This is where animals are tested upon and it is also the initial stage in the labs. The time scale varies from 3 and a half to four years and the main aim of this stage is to look at the biological activity of the compound and also to evaluate its safety. After the animal testing has been completed they company are not allowed to start testing on humans until their investigational new drug application (IND) has been approved. The company have to file a IND with the FDA, they do so to gain approval to start the next stage, which is on humans. The FDA has 30 days to disapprove. The investigation carried out looks at previous experiments and also information on the new study being evaluated i.e. how is conducting the study, where it is taking place etc. They also look at the chemical structure of the new drug and what its new purpose will be in the market. The next stage of testing...
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...Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary...
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