Transcript: The roll of the FDA is too approve a medicine and see if its effective and safe enough to sell to the public. It is important because if the FDA wasnt around they could just be selling any old medicine to the public without it being safe and effective. An example is when you worked a long time on a medicine and you show the FDA your safety and effectiveness conclusions and they test it too see if your lieing. Test and Control Groups Test groups are groups that are being tested. Control groups are groups that are given a placebo. They are important because they show the effect of your prouduct. An example is that Mrs. Tayco gave us a headache medicine but didn't tell us who was in the control or test group. When you find funding, you are finding someone who will pay for all of your expenses. This is important becausewithout a funding, you can't pay for your clinial trial expenses. An example is a foundation might pay for a clinical trial to cure cancer. The three phases are phases that you have to go through when doing a clinical trial. It is important because it helps you to have an acurate clinical trial. An example is that when you are doing a clinical trial, you will go through the three phases. Safety is the state when harms way will not come to you. It is important because it will insure that your are safe ( enough) An example is that there are shots to prevent people from diseases so they are safe. A drug discovery is when you discover a new drug It is important because when you find a new drug, you could be finding a new cure that could help people. An example is that there could be a new molecule that could cure cancer Effectiveness is when something works or goes well. It is important because if something is not effective on its purpose, there is no point to it. An example is when someone makes a product, it needs to be effective, or it is pointless to you. Advertising is when you tell the world about what you need. It is important because it will let poeple know about things. An example is when you watch tv, commercials play. Animal testing is when you test your product on animals. It is important because it will show if that product is safe enough to test on humans. An example is that beauty companys will test their makeup on rats. An informed consent is a contract that informs you about the clinical trial you are volunteering for. It is important because it will inform you about a clinical trial you are volunteering for. An example is when you give your permission for something that could possibly happen. Researching is when you find information on a certain topic. Researching is important because you need to know about a topic to write about it. An example of researching is when you go to a library and check out some books on your topic. 3 Phases Animal Testing Advertising Effectiveness Informed Consent Finding Funding Clinical Trials Safety Research FDA Poll Drug Discovery
Transcript: Produce a drug target Develop a drug Criterias of inclusion/exclusion researchers have to explain in an understandable and complete way the most important aspects of the test to each potential participants before obtaining their consent to participate. How Clinical Trials Protocol of the CT http://www.xplorehealth.eu/en/media/produce-drug-target Ethical committee Laboratory studies in vitro, that is, not in living organisms in cell culture but stuck in a test tube. . chemical profile and preliminary data on its biological activity (potency and antiretroviral activity) and possible toxicity . 5 o 6 years, during all the process Laboratory studies in vivo, ie, in living organisms. . with animals (at least 3 different species of laboratory animals) . lasts between 1 and 2 years and basically serve to exclude hazardous substances, toxicity or teratogenicity (ability to produce malformations in the developing fetus) . pharmacokinetic data and biological activity . without offering further guarantee of its therapeutic value for humans. Phase III Phases Develop a drug in this race against time! Once approved How new drugs are developed A clinical trial is: Definition http://www.xplorehealth.eu/en/media/develop-drug Why? Phase II Why do we need Clinical Trials? Phase I Before commercial distribution Detailed plan with all its characteristics in order to ensure that offers maximum benefit and minimal toxicity to the patient population to which it is intended A clinical trial is a research conducted in humans to test the safety and / or effectiveness of an experimental drug, ie a drug that is not marketed, or yes it is, but is tested in a different way from the authorized. Before the trial Informed consent http://www.xplorehealth.eu/en/media/develop-drug-race-against-time . what is to be tested and why (may be an experimental drug, a new way of using a drug already on the street, a new strategy of treatments, etc..) . which patients require test your calendar tests and visits . how it will last, how it will be accomplished, how medication, at what dose, and what risks, etc. - an experiment - terapeutic, because it has to look for treatments or solutions for a disease - it evaluates the effect of a treatment because it measures the result of the intervention in the study - does its evaluations in quantitative terms, during a concrete period of time, because it tries to measure what happens and at what frequency/rhythm Pre-clinical: the long way ... clinical trials can be used to figure out the best way to use the drug in question, ie, to answer questions such as when to take, when to quit, when to switch drugs, etc.. Elements of a clinical trial . must fulfill the call or inclusion criterion for entry into the protocol . also details the reasons for not accepting certain participants in the so-called exclusion criteria, which, at least in theory, is to protect trial participants
Transcript: clinical trials is a positive, or negative way to help patients get a match for survival. ..during clinical trials there will be diagnosis being done to donors, such as those who participate to donate an organ for someone else, but if the person is not compatible like the swab test, then they will be denied even if they went through pain and donated. procedures in clinical trials may include,hernia replacement,heart surgery or bone marrow surgery. etc.... participants can have positive or negative side effects after any type of procedures being processed. Clinical trials are studies that use humans to test medical treatments. These studies are frequently registered with the Food and Drug Administration (FDA). PROTOCOL A STUDY PALN ON WHICH CLINICAL TRIALS ARE BASED. BASICALLY DESCRIBES WHAT TYPE OF PEOPLE CAN PARTICIPATE IN THE TRIAL, SUCH AS PROCEDURES, MEDICATION AND THE DOSAGE THE PATIENT NEEDS TO TAKE according TO THEIR TYPE OF CONDITION. participants ARE SEEN REGURLARILY BY A RESEARCH STAFF TO monitor THIER HEALTH AND TO DETERMINE THE SAFETY AND EFFECTIVENESS OF THEIR TREATMENT. DO NO HARM I THINK THAT IT MEANS PREVENTING RISKS AND HAZARDS TOWARDS A PATIENT. AND THEIR POTENTIAL BENIFITS. .FIRST MUST MEET THE STANDARDS,AGE,GENDER,TYPE OF DISEASE,PREVIOUS OR CURRENT MEDICATIONS,EXISTING MEDICAL CONDITIONS. THESE ARE THE criteria LOOKED AT IF YOU QUALIFY OR NOT. WHO CAN PARTICIPATE? .HOW TO PARTICIPATE COMPLETE THE CLINICAL TRIAL PARTICIPANT FORM. -IF YOUR INTERESTED YOU WILL GO THROUGH A SCREENING PROCESS. WHICH INVOLVES A SERIES OF QUESTIONS.To determine if you meet all of the requirements for a clinical trial, a physical examination is usually conducted during the screening process. This exam may include: Measurement of your height, weight, temperature and blood pressure A test that records the electrical activity of your heart, known as an electrocardiogram Blood and/or urine samples Other diagnostic tests required by the clinical trial protocol All of the information obtained during the screening process is kept secure. If you qualify for the clinical trial, you will be contacted by the site staff to schedule any trial-related clinic visits and discuss your participation in more detail. Your participation is completely voluntary. So, even if you decide to enroll in a clinical trial, you are free to leave the trial at any time, for any reason. justice Respect for persons reflects two basic convictions: "first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection." Beneficence is understood as the obligation to maximize possible benefits and minimize possible harms in conducting research. Justice, the third of these basic principles Quiz 1.WHAT IS A CLINICAL TRIAL? 2.WHY PARTICIPATE IN A TRIAL? 3.WHAT QUESTIONS WOULD YOU ASK BEFORE PARTICIPATING? risks and benefits. Before enrolling in any study, it is important to know which of the three phases the treatment is in, to get an official report of the study, and to know the background of the institute or company conducting the clinical trial. Pharmaceutical companies have been known to take unnecessary risks with humans in order to get their drugs to market. Be careful, and do your research. clinical trials what questions should a person ask whether or not to participate in a trial. . what are my treatment options? .how will treatment on a clinical trial affect my prognosis. .what are the potential short-term and long-term side effect. . what procedures will be billed to me or my insurance. good harm in medical trial, is like creating a new medication to perform it on the patient to find a cure for maybe a bad disease. THE FACTS .CLINICAL TRIALS ARE RESEARCH STUDIES THAT TEST HOW WELL NEW MEDICAL APPROACHES WORK IN PEOPLE. .CAN RESULT IN MALFUNCTION AS I PRESENTED IN THE PREVIOUS VIDEO. THE FACTS. risks and benefits GOOD HARM THE MEDICATION WORKING PROPERLY AND CURING THE PATIENT. SATISFACTURY SURGERY. DOCTORS PRODUCING THE BEST DATA AVAILABLE FOR HEALTH CARE DECISIONMAKING... KNOW THE RISKS OF DIESEASE. bi ps u all you teachers are dumbasses clinical trials! participating to cure people who have cancer. GOOD HARM AUTONOMY .DISCOVERING WHAT IS RIGHT FOR THE PATIENT. .SELF GOVERNING OF THE RIGHT .PERSONAL LIMITATIONS. EXAMPLES. HONESTY AND TRUTHFULNESS. EVEN IF IT'S TOUGH AND IT WILL HURT THE PATIENT. .PROVIDING CONFIDENTIALITY. .BE compassionate IS THE KEY. .autonomy is experimenting medicine with a patient to see if the medication works properly. like in this video.
Transcript: 4 Clinical Trials 2 3 1 What are clinical trials? What are Clinical Trials? Clinical trials are a trusted method to determine the efficacy in an experimental form of treatment. Treatments are registered through the WHO's Clinical Trial Registry Program.  Cochrane Crowd - CT Identification Citizen Science Thousands of research papers are submitted for publication every month. Analysis of excerpts from academic research Categorise form of research design used James Lind Historical Background First physician to conduct a controlled trial. (1747)  His findings led to an improved mortality rate for british seafarers. The Trial The Scurvy Trial 12 patients were included in the trial. All exhibiting similar levels of symptoms for Scurvy. Dr Lind formed the men into pairs, and gave them differing dietary supplements to observe the impact on their condition. Trial Phases Before any treatment can be safely delivered to the public it must be tested in all CT phases. How It Works Phase 1 Preclinical Phase The earliest stage of testing done for any clinical treatment. Preclinical Always done in laboratory environment. Testing is performed on animals and human cells. Typically lasting several years. Phase 1 The first stage to introduce human participants. This stage typically takes several months. Only selects human applicants that are healthy. Establishes suitable dosage. Phase 2 Phase 2 First stage to test treatment on intended patient. Safe dosage has now been formulated. Testing for efficacy of intended use. Observation for side effects to safeguard. Phase 3 How worthwhile is this particular treatment? Sample size increased Monitoring for research bias through RCT, single/double blind testing, etc. Phase 3 Phase 4 Phase 4 Final stage before release. Sample size increased further. Monitoring for long term side effects Determining if side effects outweigh benefit of treatment. Accounting for bias Bias Bias is common for research teams passionate to find desired results. Randomised Controlled Trials Participants within a trial are chosen at random for all the different groupings to collect uninfluenced data. This variance in participants will most closely resemble the diverse audience which the treatment will eventually be made available. RCTs (RCT for back to work scheme) Single / Double Blinds Blind refers to the level of information given out in a study. Single blind is the participants not being aware of which group they are allocated (e.g placebo or not). Double blind is when neither participant or researcher is aware of the group allocations. Single/double blind Issues with Clinical Trials Issues Clinical Trials are internationally implemented and respected, so what does that mean for ecological validity if problems in methodology are overlooked? Impact of biased CTs Impact Research made into a link between measles and autism in children was found to have evident bias and was in violation of the ethics committee.  The studies findings were published, only to be retracted in 2010.  Dr. Smith highlights that: "in the time between the original publication, and later research refuting the original findings, the uptake of measles-mumps-rubella vaccine in Britain declined, resulting in a 25-fold increase in measles in the 10-year period following the original publication"  Placebo Placebo is a commonly used element for measuring efficacy of treatment. The WMA's Declaration of Helsinki states that even control groups should receive the best possible treatment available.  There is evidence for many clinical trials where participants have been administered experimental treatments in place of proven ones: Invectrin Trial 1985 - placebo was used on patients suffering from onchocerciasis. This condition causes blindness.  Contradiction Reference List Referencing Collier,R. Legumes, lemons and streptomycin: a short history of the clinical trial. CMAJ. 2009 Jan 6. 180(1):23-4.  GMC. Fitness to practice panel hearing. 2010. https://cdn.factcheck.org/UploadedFiles/gmc-charge-sheet.pdf  Smith, JE. Noble, H. BMJ Publishing Group Smith, JE and Noble, H (2014) Bias in research. Evidence-Based Nursing, 17 (4). pp. 100-101. ISSN 1367-6539  World Health Organisation. 2005. Ministerial Summit on Health Research. World Health Assembly. https://apps.who.int/gb/archive/pdf_files/WHA58/A58_22-en.pdf?ua=1  Referencing World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 1964-2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/  ROTHMAN, K.J., DRP.H. and MICHELS, KARIN B,M.S., M.P.H., 1994. The Continuing Unethical Use of Placebo Controls. The New England journal of medicine, 331(6), pp. 394-398.  Continued
Transcript: Clinical trials "may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other." The whole story is about a clinical trial. In the story, they did many experiments like the ink blot test and drawing a maze to record his devolpement. This is the kind of stuff they do at a clinical trial. They do many "mini-tests" and bring it all together and try to make something that will help humanity. They were trying to make a medicine to make people smarter. They did this on the main character, Charlie Gordon. 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 outcomes.” Cardiac rehabilitation is an intervention which has been shown in a Cochrane review to reduce cardiac mortality by 26% and overall mortality by 20% over three years. Clinical Trials By: Elizabeth Lamb, Payton Johnson, and Angel Chavez-Saiz CLINICAL TRIALS PROJECT Brief Overview of Clinical Trials "ClinicalTrials. "WorldHealthOrganization. N.p., n.d. Web. 19 Nov. 2014. "Learn About Clinical Studies. "Home. N.p., Aug. 2012. Web. 19 Nov. 2014. "Clinical Trials | Reference.com. "Clinical Trials | Reference.com. N.p., n.d. Web. 21 Nov. 2014. Cardiol, J. "Medscape Log In." Medscape Log In. N.p., 2007. Web. 21 Nov. 2014. Pictures of Clinical Trials Resources Definition of Clinical Trials How Clinical Trials Relates to Flowers For Algernon A Real World Example of Clinical Trials
Transcript: Clinical Trial Phases Why Cancer Trials are Important Types of Clinical Trials for Cancer The national cancer institute’s web site www.cancer.gov contains the latest information about standard cancer treatment, screening, prevention, genetics, supportive care and complementary and alternative medicine, as well as a registry of cancer clinical trials. What are Clinical Trials Tumor Board * Its complicated *Primary provider should make initial contact with the clinical trial staff. Designed to show how a certain anti-cancer approach affects the people who receive it Who Can Join a Trial? Research and Clinical Trials 1. A critical part of the research process 2. Involves human subjects 3. Answers specific scientific questions regarding the prevention, treatment and diagnosing diseases Glacier Oncology and Hematology Once a new drug or intervention is proven safe and effective in a clinical trial, it may become the new standard of practice. Everything we can tell people with cancer today about their treatment options is based on the results of clinical trials www.mtcancer.org Phase I – find a safe dose, administration and evaluate toxicities. (15-30 people) Phase II – Study the efficacy of the new treatment on a certain cancer. Evaluate toxicities (<100 people) Phase III – Compares new treatment to current standard of care (100- thousands of people) Further assesses the long-term safety and efficacy of the new treatment (several hundred to several thousands of people) Newly diagnosed with cancer Extensive disease. 69-year-old female with a history of rectosigmoid colon cancer resected in November 2010. Recent CT CAP surveillance imaging had revealed a new right lower lung (RLL) pulmonary nodule w/imaging characteristics most c/w new primary lung neoplasm, particularly in light of the patient’s prior smoking hx. Dr. took the patient to surgery on 10/22 with the solitary, well-demarcated nodule as expected in the upper medial portion of the superior segment of the RLL, but no other worrisome findings. Numerous lymph nodes were seen but did not appear suspicious. Intraoperative frozen section, however, was very c/w met’c colorectal pathology and permanent sections did confirm. Pathology from 2012 and 2010 will be reviewed at Conference. Nursing 387 Why Do We Do Research Example 2 What We Did? Some Therapies Treatment Prevention Early detection/screening Diagnosis Quality of life/supportive References Phase 4 Referring Patients Used to prevent bias in research The computer or a table of random numbers generates random number assignments The protocol clearly states the type of person who can or cannot participate in the trial Participant safety Accurate and meaningful study results certain type or stage of cancer Biological Therapy Monoclonal Antibodies Clinical Trial Protocols Endpoints Documenting and following patients In Summary Clinical Trials Clinical trials help to move basic scientific research from the laboratory into treatments for people National Cancer Institute (NCI) research has shown that the general public is either unaware of clinical trials as a treatment or prevention option or misinformed about the process 65-year-old male with hx of abdominal pain, bloating this was performed on 11/02. Plans were made for case review and discussion of treatment options at Cancer Conference today Standard of care Randomization Prevent Disease Find and diagnose diseases Treat disease Manage symptoms of disease or treat side effects Example 1 Who Participates in Phase 3 Trials Human Clinical Trials Cancer affects EVERYONE Approx 500,000 people die of cancer each year Cancer is the 2nd leading cause of death An Endpoint is what researchers will measure to evaluate the results of a new treatment being tested in a clinical trial. Examples of endpoints are Toxicity Tumor response Survival Quality of life Cancer Clinical Trials Where were we? National Cancer Institute. (2012). Learn about clinical trials. Retrieved from http://www.cancer.gov/clinicaltrials/learningabout Includes information on: The reason for doing the study How many people will be in the study Who is eligible to participate Requirements The endpoints of the study Deciding Who Fits a Study
Transcript: Identifying Diabetes with Respirocytes Benefits: superhuman abilities in its offspring -be able to hold their breath for hours -extending our ability to smell, hear, taste, touch, sight -faster response rate compared to traditional diagnosis meaning less damage to organs Hypothesis of the results of the trial: We predict that the respirocytes will be successful in detecting diabetes faster than common diagnosis strategies Safety: -Respirocytes injected by trained proffessional -Stay overnight at hospital for observation after respirocyte injection If the client has excess or severe headaches, nausea or vomiting, or has an allergic reaction to the respiroctyes should contact their doctor and discontinue participation in this trial. Diabetes elevated levels of glucose in the bodies Respirocyte will be able to detect amount of glucose going through the motor Sends an electric signal to a receiver Travels through the bloodstream throughout the trial Detects amounts of glucose in the bloodstream If there is an excess amount of glucose respirocyte will send a signal to receiver Works Cited "Nanomedicine Art GalleryRespirocyte Images." Web 10 May 2012. <http://www.foresight.org/Nanomedicine/Gallery/Spieces/Respirocytes. "KurzweilAI | Accelerating Intelligence." Respirocytes. Web. 10 May 2012. <http://www.kurzweilai.net/respirocytes>. Introduction to Nanotechnology." Nanotechnology Dangers. Web. 20 May 2012. <http://nanogloss.com/nanotechnology/nanotechnology-dangers/>. "What Is the Pancreas?" About.com Type 1 Diabetes. Web. 20 May 2012. <http://type1diabetes.about.com/od/type1diabetesbasics/p/What-Is-The-Pancreas.htm>. "Prospects for Medical Robots." Prospects for Medical Robots. Web. 20 May 2012. <http://www.azonano.com/article.aspx?ArticleID=2035>. overheating-rare -bio-breakdowns-very rare -could cause radiation damage after 20 years -positive test does not necessarily mean its diabetes Interference of Erythropoiesis Diabetes 1. Contains mechanical acoustic inducers located on surface of each respirocyte Who are we looking for? No chronic illness Control Group 4. Motions picked up by computer Have no metabolic conditions or diseases including diabetes Be at least 7 years of age -Take A1C test every 3 months Reflects the average blood sugar level of the past three months Analyze efficiency and effectiveness of respirocytes How Respirocyte Receiver Works 2. Glucose goes through rotor picked up by inducers on the surface Experiment Group 3.Transfers to mechanical motions Double-blind -experimental group-respirocytes injection -control group-placebo (water injection) -doctors would have container which includes both types of injections -each needle would have an identification number -doctor would randomly select needle for each patient and record patient id number and needle injection number -100,000 respirocytes in each injection You must.... How does the Respirocytes work? Description of goals of trial: Get people treatment in the beginning stages of diabetes to recognize their disorder so they can make positive lifestyle choices Risks: The pancreas maintains glucose levels in the body by producing insulin Prduces glucagon when body needs to put more glucose in the blood to be used for engery Note: insulin lowers blood glucose by helping body use glucose in the blood for energy. Glucogan raises blood glucose by causing the liver and muscles to release stored glucose quickly Type 1 diabetes: pancrease stops producing insulin Type 2 Diabetes: pancrease either underproduces insulin or the insulin that is produced cannont be properly used by the body(insulin resistance) 5. Doctor receives data Sign a consent form BMI over 30 Family History of Diabetes Sedentary Lifestyle (exercise less than twice a week) Test whether any of the patients have diabetes Three Rotors -Specially designed tips to catch particular types of molecules 1. Captures oxygen 2.Captures carbon dioxide 3. Takes in glucose powers respirocyte
Transcript: A medical proffesional interested in indepth research and finding for cures on the topic the study is on. chantelle lavandera Every clinical study is led by a principal investigator, who is a medical doctor. Also have a research team that may include doctors, nurses, social workers, and other health care professionals. Research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans and show which medical approaches work best for certain illnesses or groups of people. Statistic Involved: Clinical Research Associates in the United States can expect to earn an average of $40K to $88K annually. Requirements: What is it? The job outlook Statistical methods provide formal accounting for sources of variability in patients’responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information and to make sound decisions in the presence of uncertainty. Mastery of statistical concepts can prevent numerous errors and biases in medical research. Clinical Trials The pay: Recommend There will always be clinical trials, so there will always be a need for clinical research assistants however, those wishing to extend and make the most of their opportunities in this field should consider becoming a Clinical Research Associate which their responsibility is overseeing research assistants and ensuring that clinical trials are run properly. Uses: Establishing an objective framework for conducting an investigation Quantifying the influence of chance Estimating systematic and random effects 62 ECG bpm
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