Transcript: Did the patient take the drug? Some trials require observed ingestion Patients forget diaries all the time Trials have lots of instructions -15 minute window to take drug Without documentation patients won't count for the trial Immediate loss of ~$50,000 Time delay is very costly Resources HIPAA, GCP, ICH compliant software Must export or communicate data Patients can't pay and must use it Faking it Apple app store Google Play Website Clinical Trials: A Drug Diary App Job To Be Done Cost Structure Researchers running clinical trials that use oral drugs. Academic research hospitals, AROs, CROs, Pharma Clinical research experience Network Connections A drug diary application that can be easily programmed to fit the rules of the trial. It pings the patient when it's time to take the drug. Sends the date and time to the research coordinator in real time. Data is collected for all patients in a mission control cloud based application Minimum Awesome Product Use the Mango Health app, fill in some drug info Add a fake "send" button Deliver an email with a PDF of dates and times the drug was taken The Business Model Sort of... MetricWire presents an app for clinical research Who is the customer? Who is not? Vision Statement Vytorin made Merck $4.3B in 2013. A delay of just one day could cost millions of $$$$$ Patient support groups Research organizations Freemium app with export function included. SaaS mission-control with trial specific rules Pay-as-you-use hub $50 and per patient license ~$20 Relationships Problem Statement Scaling Pivot?! Channels The Problem Patients in clinical trials Regular folks taking meds Every new drug comes through the clinical trial process Phase I- Safety and dose Phase II- Efficacy in a small group Phase III- Compared to gold standard CareZone Look at industries that need to audit data Financial services, expense reporting, detectives Smart med bottle caps? RFID? Solution The Problem Can't be put in a research record though... Customer Aquisition App creation database connection Cloud software Solution Storming Maybe I'm wrong, or this is just a silly idea? Developers Scaling the product Value Proposition Activities PocketPharmacist The Current Solution CFO Provide proof that clinical trial participants took the drug. Data to Support this Auditable, real-time tracking of drug compliance Narrow Customer Group Scaling the Team Get research coordinators to start suggesting the Mango Health app, while also recording on paper. Med Diaries Pricing Strategy Minimum Viable Prototype How can you tell when something disappears if you can't see it? & Vision Statement So there's a blank space Refining the Solution Anything specific for trials? Mango Health The Vision Paper, that is always forgotten The Solution System to instruct, remind and confirm patients took study drug and convey data in a format that can be audited. But nothing for drug documentation Patients need to prove when they took the drug, in a way they won't easily forget. AND Researchers need drug compliance data in a consistent format that can be audited. Invest in some experts: Customer Profile Work with Mango Health to add an "export" function to their app Test Market viability on Investigator initiated trial- free version App and Cloud based The Problem
Transcript: Animal testing is importent because it shows how animals respond to madicines. ji Ex: In the C.T. of poweraid it was not safe or effective It is important because you need to sell your molecule but youy would need a lot of money so if you get money you can sell it. Example: The side effects include diarrhea nausia and dizzyness. Animal testing is importent because Example: 75% of people got better from the medicine alone. Ethical testing Teamwork It is when you look at details and improtant info on your medication It is important because it shows you who improves from the medidcine alone. Research Drug Discovery It is a form that tells people about risks and possible side effects. It is important because if you dont teel people about what can happen then it does happen, they could sue. Informed concent form Clinical Trials Ex. The orangatains died because the medicine was not safe, so it would not be safe on humans. An ethical test is an expermient that is morally accapteble based on a persons indivudial beliefs. A ct is a meathod of testing if a new medicine is safe and effective onm humans. because with out animal testing, we wouldnt know if medicines are safe on humans. It is when you find new imprortant drugs that may treat illnesses It is important because you can discover new an important drugs Ex: We discop It is important to conduct a C.T. because it would be harmful if you sell a new medicine withought testing because you dont know if it is safe or not. Ex: Windmill farms is going do pay for our moleculee because the molecule helps with plant and food poising. Finding Funding It is important to weich the traid offs in deciding if something is ethical just because we can do something Example: it is when you get money to help pay for your new molecule It is important because you need to find info about your medicine to see if its safe or not. Treatement and control groups. Control Group is when the volunters get the placebo of the medicine. Treatment is when they get the actual meidicine. ANIMAL TESTING Ex: Many people think the test of Bonie is unethical because she did not give people a chance to decide for themselfs and she gave them a life threatining disease.
Transcript: Some reasons include: Personal Fears & Anxiety logistical Barriers Cultural Differences Not having a full understanding of Clinical trials Website Recruitment Strategies Clinical trials: are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies may also show which medical approaches work best for certain illnesses or groups of people. Most people find out about Clinical Studies through the internet and media outlets. There should be more money allocated to ad's on TV and on the internet. It would be really smart to advertise a website that will teaches people what Clinical Trials are. The website would include: Purposes of Clinical Trials Benefits and Risks Examples of Clinical Trials that were beneficial Clinical Trials Nearby Clinical Trials that that fit the participants criteria Clinical Trials Benefits: Access to promising new treatments often not available outside the clinical-trial setting Close monitoring, advice, care, and support by a research team of doctors and other healthcare professionals who understand your disease or condition The chance to play an active role in your own healthcare and gain a greater understanding of your disease or condition The chance to help society by contributing to medical research. Risks: The clinical trial may require more time than a non-clinical trial treatment. There may be unpleasant, serious or life threatening side effects to experimental treatments. design by Dóri Sirály for Prezi Importance of Clinical Studies within these groups Many health disparities are unaddressed. For example, the rate of new AIDS cases in 2003 was 3 times higher among Hispanics and 10 times higher among African Americans than among whites. Women make up more than half of the U.S. population. The census projections show that by 2043, ethnic minorities will be the majority in the United states. Addressing the specific health issues will become a vital aspect of public health since these groups are becoming the larger sections of the American population. We can better include African Americans and Minorities by ensuring that the beneficial outcomes of the study. o Maintain a level of trust. o Maybe have benefits such as getting paid. Educating people about the importance of clinical studies. o Tell them the importance of clinical. o Show them statistics. Making positive public perceptions and try to dispel all the negative stigmas. o Dispel bad stigmas about clinical studies. o Allow the participants to trust you. Helping out with logistical barriers. o Implement childcare. o Provide public transportation. o Provide benefits for children. Benefits & Risks of Clinical Trials Women and minorities remain underrepresented in clinical research Clinical Trials
Transcript: to qualify: - currently taking one or more medications for chronic low back pain. - have a diagnosis of moderate to severe chronic low back pain, not due to cancer or injury to the nerves, as a primary conditon for at least three months . Do you have trouble sleeping? and wish you could get a good night sleep? got type 2? to be eligible: - currently taking medication for asthma - have had at least 2 asthma attacks within the past year that may have required steroid use or a visit to the er or an urgent care center. Clinical Trials BioMedical Technology I Grace Bringer and Mary Valencia November 9, 2015 What is it? Dry Eye Study What medication? new eye dry treatment. Age Group? at least 18 years of age How long? Compensation? No a clinical research study to evaluate an oral investigation drug for type 2 diabetes. Do you have dry eyes? struggling with asthma even with medication? What is it? Research study of an investigational medication to treat sleep problems. What medication? Age Group? The study is for men and women 18 and over. How long? Compensation? No compensation refer a friend who has allergies and you may recieve $250 for each person reffered. What is it? study for investigational medication What medication? trimed study medicatonal Age Group? 18-65 How long? Compensation? MAy recieve compensation for time and travel to be eligible you have to - have a blood test What is it? CLincal trial for type 2 diabetes What medication? taking metformin at least 1500mg a day. Age Group? at least 18 years of age How long? Compensation? none What is it? currently enrolling qualified participants in a clinical research study. What medication? Age Group? ages between 9 and 45. How long? six visits Compensation? may receive compensation for time and travel. ARe you suffering from depression? What is it? an investigational once a day pain medication for patients who have been medically diagnosed with moderate to severe chronic low back pain. What medication? a once a day medication Age Group? at least 18 years of age How long? Compensation? compensation for time Must be in good health willing to make office vistts Not taking any other medication to qualify: - you haven't had eye surgery in the past three months. - you aren't pregnant - you don't have punctual plugs What is it? trial that may reduce dust allergy symptoms. What medication? Age Group? 7 to 45 How long? Compensation? qualifying participants may recieve $8,435 upo study completion. do you suffer from chronic low back pain? What is it? Medication for asthma What medication? Age Group? ages 12 to 75 with asthma How long? Compensation? compensation for time suffer from dust allergies? searching for a new acne treatment? all trial visits, tests, and medications will be provided to participants at no cost.
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: Set-up: review protocol build prescriptions, I/V componant? Baxter involvement to set-up OR aseptic unit - worksheets... write dispensing guide costing review accountatibilty review source drug supply? SQV, SIV check another CT pharmacist's work Rx, dispensing guide December 2016 1. Status quo not an option - at capacity now, patient safety & quality compromised. 2. Capital investment in dispensary and staff for increased capacity 3. Halt new studies - control demand on trials service 4.0 WTE Clinical Trials Pharmacists AP Phase I NK overall service OVERVIEW The Oak Road Dispensary Technician-led service Redefine roles - skillmix Identify opportunities - projects, audits, pharmacy research Develop the team - e.g. prescribing & clinics A newly designed workspace to increase storage capacity Nisa Khan, Lead Clinical Trials Pharmacist Clinical Pharmacy ward and dispensary provision Aseptics - largely CT support Baxter - non-trail and increasingly CT provision Electronic Prescribing team - new prescribing system implementation Dispensary system - JAC for dispensed productc and now aseptic (31st Jan) On-call commintments Diploma/NMP Student Placements National work - dose banding, antibiotic stewardship Growth and future proofing Clinical Trials Pharmacist - Interviews in Jan '16 Clinical Trials Technician - Appointed Dec '16 Clinical Trials Invoice Administrator - Appointed Dec '16 Activity increasing at a much greater rate than studies closed and in follow-up. See handout for breakdown of disease groups and of number of studies expected to recruit in Jan 2017. MISSED OPPORTUNITIES OPTIONS? Decreasing IMP storage space & workspace MEET THE TEAM Nisa Khan, Lead Clinical Trials Pharmacist Requests to join ethic committees across Manchester Active involement in the NW pharmacy clinical trials network Horizon scanning for new and interesting opportunities available Monitoring Visits RECRUITMENT Timeline Non-hosted Clinical Trials Activity CTIMP ACTIVITY Sponsored CTIMPs - open e.g. ABC-08 Sponsored CTIMPs - in set-up i.e. PARIS Eternal requests - for multicentre studies - COPELIA & UoM Request to mananage IMP aspects including vendor assessment? OTHER PRESSURES The Next Steps? Part of a wider team Pharmacy Department BUSINESS MODEL Pharmacy Clinical Trials Service Open studies: audits screen CT Rx r/w amendments implement changes e.g. new eRx, worksheets... Over 50 CTIMPs currently in set-up Monitoring Visits Monitoring Visits
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: Phase 4 Collection Analysis Healthly? Inclusion/Exclusion criteria http://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/types What is a Clinical Trial? New treatments, vaccines, drugs, dietary supplements and medical devices 100-300 people effectiveness and safety Cancer Protocol References 20-80 people safety, dosage, side effects Principal Investigator Why? Who? How many? Drugs? Test? Information collected? 1000-3000 effectiveness, monitor side effects and compare to other studies Types of Clinical Trials After on the market Effects in various populations Long term side effects Phase 1 http://dcru.org/volunteers/who-can-participate-clinical-trials Phase 2 Research Study Scientific Validity Reproducibility of results Costly Human Participants https://www.nlm.nih.gov/services/faq.html Phase 3 Usually sponsored government organization pharmaceutical medical companies Questions? Clinical Trials Treat Find and Diagnose Prevent Screen Support
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