Fluent Essays

Prompt: You work for a small drug company that focuses on treatments for atrial fibrillation. It is postulated that the current drug in development (FK67T) reduces the incidence of severe chest pain, severe tachycardia and lowers blood pressure without the extreme fatigue, severe dizziness and bouts of depression associated with high dose metoprolol. Furthermore, it was found that a 7.5mg dose of FK67T given twice daily was as effective as 10mg metoprolol given three times daily in a canine model of hypertension. However a 40. mg dose of FK67T given twice daily at the same animal model produced persistent and unacceptable occurrences of severe bradycardia. Please design a phase 2 study to identify an acceptable dose of FK67T for a subsequent phase 3 study.3. STUDY DESIGN 3.1. OVERALL DESIGN This is a phase 2 study that seek to identify an acceptable dose and evaluate the efficacy, safety, tolerability, and pharmacokinetics of orally administered drug FK67T in human subjects for the treatment of the symptoms of atrial fibrillation. This drug (FK67T) has been shown to reduce the incidence of severe chest pain, severe tachycardia, and lowers blood pressure without the extreme fatigue, severe dizziness and bouts of depression associated with high dose metoprolol. Earlier studies demonstrated that 7.5 mg dose of FK67T given twice daily was as effective as 10 mg metoprolol given three times a day in a canine model of hypertension. This study is a randomized double blinded placebo control clinical trial that utilizes block randomization. Dose ranges from 7.5 mg to 37.5 mg and are given twice a daily to human subjects at a single site with an intension to treat. 3.2. SCIENTIFIC RATIONAL FOR STUDY DESIGN FK67T has demonstrated efficacy in non-human subjects for the treatment of symptoms of atrial fibrillation. FK67T also demonstrated acceptable safety profile in healthy human subjects during a phase 1 clinical trial. The result of the phase 1 clinical trial informs the basis of dose parameters to be studied in phase 2 clinical trial. A dose of 40 mg of FK67T given twice a day had produced unacceptable side effects in animals during preclinical studies and in humans during phase 1 clinical trial. A two times daily dose of 10mg, 20 mg, and 30 mg will be evaluated for safety, efficacy, and tolerability in a placebo control trial. Only one of the three doses will be administered to each participant for the entire study duration. By utilizing a multi dose, randomized, double blinded, placebo control trial, the effectiveness, safety, and tolerability of FK67T can be evaluated for each respective dose. This also helps ensure that biases are eliminated to improve the quality and reliability of the data generated. 3.3. JUSTIFICATION FOR DOSE The choice of 10 mg, 20 mg and 30 mg helps provide data that will help clinicians to evaluate the effectiveness, safety, and tolerability of drug FK67T at each respective dose compared to placebo. This helps in determining the most effective dose, minimal effective dose, and maximum effective dose. All three doses were chosen with an intension to avoid the 40 mg dose which had previously been shown to induce unacceptable side effects. 3.4. END OF STUDY DEFINITION The duration of the clinical trial will be for 90 days and would be considered completed when participants are no longer being examined or the last study visit had occurred. A participant will be considered to have completed to the study if he/she had completed all aspects of the study including scheduled visits and procedures.<Protocol Title> Version <x.x> Protocol <#> <DD Month YYYY> PREFACE Remove this Preface before finalizing and distributing the clinical trial protocol. This clinical trial protocol template is a suggested format for Phase 2 and 3 clinical trials funded by the National Institutes of Health (NIH) that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. Investigators for such trials are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful to others developing phase 2 and 3 IND/IDE clinical trials. The goal of this template is to assist investigators to write a comprehensive clinical trial protocol that meets the standard outlined in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). Its use will also help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data. A common protocol structure and organization will facilitate protocol review by oversight entities. It is important to note that the clinical trial protocol template is just one piece of information required for an IND or IDE submission. For complete details on IND or IDE submissions see 21 CFR Part 312: Investigational New Drug Application or 21 CFR Part 812: Investigational Device Exemptions, respectively. How To Use This Template It is important to incorporate all sections of the template into your protocol and to do so in the same order. If a particular section is not applicable to your trial, include it, but indicate that it is not applicable. This template contains two types of text: instruction/explanatory and example. Instruction/explanatory text are indicated by italics and should deleted. Footnotes to instructional text should also be deleted. This text provides information on the content that should be included. It also notes if a section should be left blank. For example, many headings include the instruction, “No text is to be entered in this section; rather it should be included under the relevant subheadings below.” Example text is included to further aid in protocol writing and should either be modified to suit the drug, biologic or device (study intervention), design, and conduct of the planned clinical trial or deleted. Example text is indicated in [regular font]. Within example text, a need for insertion of specific information is notated by <angle brackets>. Instruction/explanatory text should be deleted. Example text can be incorporated as written or tailored to a particular protocol. If it is not appropriate to the protocol, however, it too should be deleted. The section headers include formatting to generate a table of contents. Version control is important to track protocol development, revisiSouth College Consent to Participate in Research Study Title: Development FK67T Researcher: ADD PRINCIPAL INVESTIGATOR’S NAME AND CONTACT INFORMATION HERE. · You are being asked to participate in a research study. This consent form contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to ask questions before making your decision whether or not to participate. · Your participation is voluntary. Your participation in this research is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you or loss of benefits to which you are otherwise entitled. Your decision will not affect your future relationship with South College. If you are a student or employee at South College, your decision will not affect your grades or employment status. · Purpose of the research. Our research purpose focuses on the development (FK67T) that will help to reduce the incidence of severe chest pain, tachycardia and lower blood pressure without severe fatigue and dizziness and depression associated with high-dose metoprolol. · Number of people being asked to participate in the research. There will 50 patient who will participate in this study helps to evaluate the safety and efficacy this drug · Duration of your participation. Max 5-6ADD TEXT HERE ON THE AMOUNT OF TIME, NUMBER OF ENCOUNTERS, ETC., IT WILL TAKE FOR THE SUBJECT TO PARTICIPATE IN THE RESEARCH. · Description of procedures to be followed in the research. This research involves a blood sample to see the safety and efficacy of new compound. However, blood sample is painless · Reasonably foreseeable risks or discomforts. Any risk can appear during the process. The health care worker will be looking after you. · Benefits to you or others that may reasonably be expected from the research. If you participate in this research, you will have the following benefit for you: any interim illnesses will be treated at no charge to you. There may not be any benefit for you, but your participation is likely to help us evaluate the safety and efficacy of this compound. · Alternative procedures. If Patient does not want to participate in clinical trial, they can have alternative treatment. · Confidentiality of records identifying you. The information and data we will collect from this trial will kept confidential and it will be safe in computer. Computer will have password, and no one will be able to get into it except professionals. Any information about you will have number on it instead of your name only researcher will know what your number. As we already mention that all the information will be in computer and no one will be able to access the information except company and sponsors. · Answers to your questions. For questions, concerns, or complaints about the study you may contactStudy Enrollment and Withdrawal 5.1 Inclusion Criteria To be included in the trial, patients must fulfill the following criteria: 1. Written consent to participate in the study 2. Subjects must be at least 18 years old 3. Symptoms consistent with pain within the past 6 months 4. Male and females’ subjects are eligible. If female, subject must be not of childbearing potential. 5. If female and of childbearing potential, subject must be non-lactating and non-pregnant. 6. Subjects must have body weight of 45 kg 7. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. 8. Patients must be healthy 5.2 Exclusion criteria Patients fulfilling at least one of the following criteria may not be included in the study: Disease-related criteria 1. History of gastritis, peptic ulcer disease, gastroesophageal reflux disease, ulcerative colitis, or another inflammatory bowel disease 2. History of bleeding disorder 3. History of acute or chronic hepatic disease 4. History of congestive heart failure 5. History of renal insufficiency or failure Previous or concomitant treatment related criteria 1. Treatment with glucocorticoids in the past 2 weeks 2. Having already taken some form of analgesia, including acetaminophen, non-steroidal ani-inflammatory drug (NSAIDs), or opioid or nonopioid pain relivers Patient-related criteria 3. Active substance abuse (drugs or alcohol) or history of substance abuse within the past 12 months. 4. Females who are pregnant or nursing or planning to become pregnant during the study; men who plan to conceive during the study. 5. Any clinically significant acute or chronic medical conditions, that would limit the patient’s ability to complete the study and/or compromise the objective of the study. 5.3 Strategies for Recruitment and Retention A maximum of 75 patients that meet the inclusion criteria may enrolled in each protocol. A total of 2 groups, for a total of 150 people. 5.4 Patient withdrawal or Termination Each treated patient in this study receives the study medication in a three-dose series (every 12 hours). Patient shall be informed of their right to discontinue from the study at any time and for any reason. If the patient does decide to leave the trial at any time, the lead investigator must: · Document in the patient’s reason and timing of discontinuation · Document if the patient experienced any adverse effect when leaving study. 5.5 Subject compensation As per the rule, the financial compensation the patients will be entitled to finical compensation. In case of clinical trial related death, the patients will be entitled to finical compensation will be over and above the expense incurred on the medical management of the trial subject.