...PHASES OF CLINICAL TRIALS Introduction Clinical Trial Definition: “Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug. “ Drug Development Process: The process of drug development can be broadly classified as pre-clinical and clinical Pre- clinical refers to experimentation that occurs before it is given to human subjects; whereas, clinical refers to experimentation with humans. Within the realm of clinical research, clinical trials are classified into four phases. [pic] Classification of Various phases of clinical trials: There are five different phases of clinical trials, which include: ➢ Phase 0 Trials (Micro dosing trials) ➢ Phase I Trials (Human Pharmacology/ First time in Man Studies) ➢ Phase II Trials (Pilot Trials/ Therapeutic Exploratory trials) ➢ Phase III Trials ( Expanded clinical trials/Therapeutic Confirmatory trials) ➢ Phase IV Trials ( Post Marketing trials) 1. Phase 0 Trails/Micro dosing Trials: Micro dosing, or human phase 0 clinical trials, is a technique whereby sub pharmacological doses of prospective drug candidates are administered to human volunteers. A micro dose study provides early pharmacokinetic data in humans and only requires minimal preclinical...
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...Welfare Basic principles on Global Clinical Trials* Up to the present according to “Ethnic Factors in the Acceptability of Foreign Clinical Data” based on ICH-E5 guideline (Notification. No. 762, Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare, dated August 11, 1998), utilizing foreign clinical trial data in a new drug application what is called “Bridging” has been accepted in Japan, and post-marketing data in USA and EU have been taken into consideration in a review for regulatory approval where necessary. On the other hand, in the report entitled “Institutional reform for promoting science and technology and passing on the benefits of the scientific and technological advance” (Council for Science and Technology Policy, dated December 2006), it is mentioned to encourage global clinical trials in terms of efficient and rapid developments of new drugs. Moreover, in the final report of the special committee for “Effective & Safe Drugs Quick to Patients” (dated July, 2007), it is pointed out to promote global clinical trials in order to resolve “Drug lag (Circumstances where drug approved in EU and US are not approved in Japan and can not be provided to nations)” and to clear points to consider for conducting global clinical trials from the perspective of a review for regulatory approval. Taking into account the situation, current understanding regarding global clinical trials based on experiences in PMDA consultations...
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...Clinical trial budget Clinical Trial/Study according to ICH E6, Good Clinical Practice : Consolidated Guideline is any investigation in human subjects intended to discover or verify the clinical, pharmacological, and or other pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.” Earlier clinical research was carried out by medical school departments and physicians who conducted studies in addition to full clinical practice without any financial pressure or monitory benefit involved. Medical Schools and centres find clinical trials as a means of generating funds moreover numerous CRO have now sprung up around the world and major stock...
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...Are Controlled Clinical Trials Really Ethical? Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care treatments only work in a very small percentage of patients and are very toxic with terrible side effects. Thomas learned of a new Phase 3 clinical research trial sponsored by Roche with an unapproved yet promising drug. His doctor explained that in earlier trials, a majority of volunteer patients who took the wonder drug had seen a drastic reduction in the size of their tumors with very few side effects. The only way ill patients can get the drug is by participating in this trial. The trial is a randomized controlled trial (RCT) which means half of the volunteers will get the experimental drug while the other half will be treated with another standard of care treatment. The purpose of the standard or control arm is to allow researchers to compare the long term effects of the new drug to that of the current standard treatment and determine whether it actually shrinks tumors and prolong remissions. Participants have a 50/50 chance of being placed in either arm of the study. Arm assignments are random and cannot be changed. With limited options...
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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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...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings...
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...Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring. Some people are against offshoring because they feel as if the working conditions in other countries aren’t up to par and are unethical. Some people are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring because they feel there is greater profit involved or that they can get harder workers in other countries. No matter what side of the debate, everyone can agree on a few things like there needs to be better standards for working conditions, proper safety measures, and high economic and ethical concern. The case Ethics of Offshoring: Novo Nordisk and Clinical Trials in Emerging Economies was a highly informative case on clinical trials and offshoring. There was a reporter who wanted to speak with Anders Dejgaard, chief medical officer of Novo Nordisk, about his take on the offshoring of clinical trials by Danish companies as there had been multiple reports about trials being conducted in developing countries under unethical conditions. When reading the case, it truly made me consider aspects that I had never considered before. There are a few underlying questions that I feel need to be discussed. First of all, when considering both economic and ethical aspects, is it appropriate...
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...head: Increasing Recruitment and Retention of Minority People in Clinical Trials Name Course Tutor Date Introduction Clinical trials are faced by numerous problems among them being difficulties in recruitment and retention of minority groups. The challenges that are faced in recruiting and retaining these groups have been well documented through various researches. In order to successfully recruit and retain minority people in clinical trials research in the health fields must undertaken beyond the traditional methods so that the barriers prevalent in the process of recruitment and retention can be overcome. Some of these barriers are related to mistrust and fear of science-based experiments following a history of atrocities committed in the name of science (Area, Alvidrez, Nery, Estes, & Linkins, 2003). This essay is going to highlight the strategies to increase recruitment and retention of minority people participation in clinical trials. Discussion Background Ethical consideration in medical research and clinical trials particularly with regard to humans came into the limelight in the first half of the 20th century following the medical experiments conducted by the Nazis on humans. These experiments saw the development of the Nuremberg code, which began a wide range of regulations that emphasized on the need for the protection of human beings who participated in trials that were prevalent in medical research. Principles that were articulated...
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...Tobacco Clinical Trials Name Instructor Institution Laboratory testing In the laboratory, chemical tests are conducted to assess the extent to which the level of toxicants from the new tobacco modified product will reduce as compared to the ordinary produced tobacco cigarettes, biological tests are also conducted to plot the early indication of whether the newly modified tobacco products provide assurance that the risk of harm will not be increased at an expense of other factors(Rees, et al., 2009). In practice, some of the laboratory testing methods and techniques has already been developed. Only the necessary amendments are required determine the effects of creating a new product from tobacco that's modified to provide salbutamol sulfate, also known as albuterol.Laboratory testing of the modified tobacco product may involve three methods; I. Use of models such as mouse II. Using prototypes such as machines III. Use of real humans(The Trustees of the University of Pennsylvania, 2009) Mouse models may be useful in pharmacology and molecular biology to elucidate the behavioral and molecular basis of effective and cognitive signs of nicotine withdrawal. Mouse can mimic individual biologically induced behavioral deficits that are hypothetically associated(Tobacco Products Scientific Advisory Committee, 2012). This is because they have some genes similar to those in humans and therefore may be of great importance in this set up. However, mice are not always reliable...
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...Tobacco Clinical Trials Name Instructor Institution Laboratory testing In the laboratory, chemical tests are conducted to assess the extent to which the level of toxicants from the new tobacco modified product will reduce as compared to the ordinary produced tobacco cigarettes, biological tests are also conducted to plot the early indication of whether the newly modified tobacco products provide assurance that the risk of harm will not be increased at an expense of other factors(Rees, et al., 2009). In practice, some of the laboratory testing methods and techniques has already been developed. Only the necessary amendments are required determine the effects of creating a new product from tobacco that's modified to provide salbutamol sulfate, also known as albuterol.Laboratory testing of the modified tobacco product may involve three methods; I. Use of models such as mouse II. Using prototypes such as machines III. Use of real humans(The Trustees of the University of Pennsylvania, 2009) Mouse models may be useful in pharmacology and molecular biology to elucidate the behavioral and molecular basis of effective and cognitive signs of nicotine withdrawal. Mouse can mimic individual biologically induced behavioral deficits that are hypothetically associated(Tobacco Products Scientific Advisory Committee, 2012). This is because they have some genes similar to those in humans and therefore may be of great importance in this set up. However, mice are not always reliable...
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...Protocol Provider’s participation in clinical trials as an investigator is critical in development and advancement in treating diseases with new medicines, devices or protocols. Advantages of participation include; professional development, recognition as a leader in the medical community, potential for increased compensation and personal satisfaction. It should be noted not ALL studies provide physician compensation. There is also an advantage to patients whose physician is also a clinical investigator, they can have confidence you will have the ability to consider any potential conflict between the study and their current treatment. The existing clinical trials department provides the necessary support to physicians and participants. The team is responsible managing a trial, providing the required documentation to the trial sponsor and FDA. The team also meets operational and oversight requirements of participating in a clinical trial. The physician’s primary responsibility remains with the patient and the providing assessments and recommendations to care. Clinical trial may provide possible treatment options through either new drugs, or there may not be at their disposal, without the clinical trials. Often time’s additional care and tests are paid for through the study sponsor which means there is little cost burden to the participant. Since these tests are paid by the sponsor, this means revenue potential to the practice. A2. Clinical Trial Phases A research study could...
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...business strategy for different clinical trials phases and ultimately short-term and long-term business strategy. Nucleon is a small biotechnology company who focus on developing Cell Regulating Protein-1 (CRP-1) pharmaceutical product. Company started with research scientists and their entire focus was on research and development. Nucleon finished the pre-clinical trial with positive results and they are ready to perform clinical trial on human. Nucleon also has very good advantage over technology and has very good linkage to the universities and research group. Till this point Nucleon’s focus was entirely on R&D with no consideration CRP-1 manufacturing process at the large scale. Now as Nucleon ready to perform clinical trial on human, nucleon has to consider different manufacturing options and finalize it before it is too late. Nucleon has three manufacturing process option for phase I and II: 1) Build an in-house pilot plant. 2) Contract production to a third-party. 3) License the development and manufacturing right to corporate partner for initial fee and royalty on sale. By considering advantages, disadvantages and SWOT analysis of different manufacturing options, Nucleon has to choose the right decision to sustain in short run and to last in long term business in highly competitive pharmaceutical industry. Key points, opportunities and recommendation: * Key issue of the case is to identify the right manufacturing option for clinical trial Phase I and Phase II. Nucleon...
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...Research Paper 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...
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...Dr. Burns Case Study Assignment 1 Operations Management 505 Submitted to Coach Jan Wirsam From Lise Beland June 21, 2013 Word Count: Table of Contents Background …………………………………………………………………………..1 The Technology……………………………………………………………………....2 Operations Strategy………………………………………………………. ……….. 3 Cash Flow Statements…………………………………………………………………………….4 Clinical Trial Work Design Process…………………………………………………4 Final Recommendation……………………………………………………………….5 References………………………………… …………………………………………6 Background: Dr. Nicholas Burns, a sole practitioner dentist in a small town in Ontario, is considering the purchase of a new dental laser which allows dentists to perform certain dental treatments without anesthesia. He wondered if the benefits of the new dental laser would justify the expenditure. Dr. Burns knew he should consider whether the technological advantage offered by the new dental laser would improve his office's profitability and the possibility that a different technology may become the standard in the industry. Issue 1: Will Waterlase become a sought after technology? OPERATIONS STRATEGY Analysis 1: Waterlase is a proven technology that provides the patient with a revolutionary treatment. The laser has been approved by Health Canada since 1998 and it main benefits enable better clotting and healing on soft tissues. The reduced...
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...Today's healthcare environment is increasingly complex, as issues compete for importance. As a consequence of this, nurses frequently face ethical dilemmas. In deciding the best course of action in such dilemmas, nurses can look for guidance to professional standards of conduct, such as those enumerated in the Code of Ethics of the American Nursing Association (ANA). According to Mahlmeister (1996), each nurse should own a copy of the ANA code, as this document can provide guidance on situations that nurses face on an almost daily basis. For example, consider a situation that may result from one hospital trying to institute policies concerning cost containment. In order to keep the cost down, the nurse in charge of a 7 bed unit (without a nurse's assistance) is expected under a restructuring plan to also work a second adult ward if there are fewer than three children on the pediatric unit during the night shift (Mahlmeister, 1996). This split shift leaves these pediatric patients unattended while the nurse is in the adult ward. The ANA Code of Ethics states that it is the nurse's responsibility "to safeguard the client and the public when health care and safety are affected by incompetent, unethical or illegal practice of any person" (Mahlmeister, 1996, p. 130). Even though this nurse was ordered by a manager to leave the pediatric setting, the nurse is personally accountable for his or her actions for any situation that may arise during this absence. Not only is this practice...
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