A new article published in Circulation by a group of authors from the Duke Clinical Research Institute describes tensions between pragmatic clinical trial design and Good Clinical Practice (GCP) guidelines, which were established in 1996 to help ensure the safety of participants in clinical trials and the validity of trial findings. Regneron COVID studies - Clinical Trial. Designed primarily for clinical fellows who are training for academic careers, the Program offers formal … The Duke Comprehensive Parkinson’s Disease and Movement Disorders Clinic conducts a variety of clinical trials. Join a COVID Research Study & Help End the Pandemic in Our Community. The Master of Health Sciences in Clinical Research program awarded by the Duke University School of Medicine provides academic training in the quantitative and methodological principles of clinical research. Why is the study needed and what important questions will it answer? DERIVe (Glioblastoma) - Clinical Trial. How are the study data and patient safety being monitored? Updated: August, 2020. Will I know what treatment I am receiving? We are currently conducting trials in each of these areas. We are doing this study to understand whether the study vaccine, called pp65 CMV dendritic cells, can trigger your immune (protection) system to fight off the tumor cells in your brain. Select any filter and click on Apply to see results, Duke Adult Blood and Marrow Transplant Clinic, Duke Cancer Center Cary Radiation Oncology, Duke Regional Hospital Colorectal Surgery, Cancer Support Calendars (Durham & Wake Counties), DCI Center for Prostate & Urologic Cancers, Office of Cancer Research Career Development (OCRCD), Duke Supportive Care & Survivorship Center, Hematologic Malignancies and Cellular Therapy. … Chronic Kidney Disease. We are doing this study to test the study drug (REGN10933+REGN10987) and understand if it can improve health … See listed clinical studies related to the coronavirus disease (COVID-19) Why do researchers believe the treatment being tested may be effective? The Duke Clinical Research Institute, part of the Duke University School of Medicine, is the world’s largest academic clinical research organization. How long do I have to decide whether or not I want to participate. “Exclusion criteria” are factors that disqualify someone from being in a study. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Most of this information will also be in the informed consent document you will need to sign before you join a study. We conduct innovative research to deliver on our mission to share knowledge that improves health around the world. He said he started feeling a little achy last month during his daughter’s baby shower, which … Nephrology Clinical Trials and Other Human Subject Research Seeking Enrollment at Duke. A Clinical Trials Manual from the Duke Clinical Research Institute Lessons From A Horse Named Jim Second Edition Margaret B. Liu Principal, Clinical Trials Consulting Singapore (Formerly Manager of the Monitoring Group at the Duke Clinical Research Institute, Durham, North Carolina, USA) and Kate Davis Clinical … Clinical Trials Duke infectious disease specialists offer patients access to new therapies through participation in carefully designed clinical trials. What happens if I become sick while participating in the study? DGHI is pleased to share these documents with others who are working in resource-limited locations. Glomerulonephritis. What are the possible benefits of participation? Accordingly, the Duke-Margolis Center for Health Policy , under a cooperative agreement with the U.S. Food and Drug Administration (FDA), is convening this public meeting to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant people in clinical trials. Are there reasons I might be removed from the study? These efforts ensure our patients receive more personalized treatment options. For the latest information about how we are keeping our community safe, please visit www.dukehealth.org. What Are Clinical Trials? You may be eligible to participate in our clinical trials, which test new cancer therapies, and explore genomics, the study of genes, how they function, and their impact on health. Our extensive research programs give our patients access to groundbreaking developments in patient care through carefully designed clinical trials. While every study is different, here are some general questions you will want answers to before you decide. For questions regarding cancer trials at Duke, please … What treatments will I receive during the study? Dialysis. What is the Purpose of this Study? Some clinical research participants may experience complications that require medical attention. Trials … The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. As a result, we offer a broader selection of medical, surgical and minimally invasive options to more people, including those who are not considered candidates for treatment elsewhere. Clinical Trials: N/A. Our experts across all cancer specialties participate in national clinical trials and perform the most advanced treatment methods using the latest technology available. Contact John P. Middleton, MD if you are interested in more information. Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future. Participant materials for clinical research, including study flyers, advertisements, social media posts, marketing materials and informed consent forms, should be participant-centric, engaging and written using plain language. When and where will study results and information go? ©2021 Duke University and Duke University Health System, All Rights Reserved. Jennifer Green, MD, is a professor of medicine and endocrinologist at Duke University and a member of the Duke Clinical Research Institute (DCRI).Her research has focused upon strategies to treat diabetes and reduce the risk of cardiovascular and other complications. What is the Purpose of this Study? Our clinical trials and studies are open to the entire community, and we invite you to be part of the solution and help end the pandemic in our community and everywhere. Use the links below to find a clinical trial that is actively seeking patients, or read more about clinical trials at Duke. Some trials may not be listed below. By volunteering you may help researchers: Clinical trials require different types of people. Or you may participate in a classroom, in your own home, or through an online survey or questionnaire. Can I choose to remain on this treatment after the study is over? Leading clinical trials is an important part of our mission to continually seek out better treatments and cures for those affected by movement disorders. DURHAM, N.C. (WNCN) — Duke is part of a clinical trial studying a monoclonal antibody treatment for COVID-19 similar to the one President Trump was recently given. Clinical Trials Learn Everything About Duke Clinical Trials Clinical trials have become a powerful method for improving existing drugs and therapies, as well as for discovering new ones. The research team should be able to answer your questions before you decide. Home Clinical Trials at Duke Clinical Trials Directory. Follow us on Facebook at Discover Duke Research, Contact the Such experiments provide answers to some crucial questions, and it usually depends on them whether a certain type of … Will I have to pay for any part of the study? A clinical trial is a research study involving human participants that aims to understand the effects of a certain drug, device, or treatment. What are the possible short- and long-term risks or side effects I might experience? Clinical Trials at Duke Studies and Research that Answer Health-Related Questions Duke Health’s top priority is protecting the health and wellbeing of our patients, visitors, research participants, and team members. How will you protect my privacy and the confidentiality of my health and research records? Duke Clinical Research Institute (DCRI) is an academic-based coordinating center for multisite clinical trials, with expert thought leaders across disciplines.The DCRI performs outcomes, comparative effectiveness, and quality of life research. Jonathan Pannaman took part in that clinical trial. Title picker The hiring manager (or person most knowledgeable about what the new hire will do) should email wer-jobs@duke.edu to request a title picker survey. They also ensure the study results are due to the treatment being studied and not other factors or chance. For more information about the Neonatal Perinatal Research Unit or to learn more about our clinical trials, email us at npru@duke… As the recipient of millions of dollars annually in research funding, we offer our patients access to clinical trials at the forefront of treatment development, as well as advances in technologies and techniques, long before they become routinely available. Clinical Trials The Duke Department of Neurosurgery is actively involved in clinical research to improve treatment options for patients at Duke and around the world. that you collect for the study? You may need to visit the hospital, doctor's office, or nursing home. Menu. To learn more about the Duke Intensive Care Nursery, visit the Duke Division of Neonatology website. COVID-19 Vaccine Updates | Join Our Vaccine Waiting List | Safety Precautions in Place | Visitor Restrictions. Will I have to be hospitalized for any of the tests, procedures, or treatments? You may be eligible to participate in our clinical trials, which test new cancer therapies, and explore genomics, the study of genes, how they function, and their impact on health. These factors can include: There are different ways to participate in clinical research. Home Clinical Trials at Duke. 3.) It is rare for people to be seriously injured or die from complications related to clinical trial participation. What will happen to my samples (blood, tissue, etc.) ¿Cuál es el propósito del estudio? In order to create a new clinical research position (or reclassify an existing employee into a new clinical research position), please us the process below. How likely are those results to apply to me? 2018-Present: Dr. Hiroyuki Hino; ... clinical trials; clinical trials. These criteria ensure it is safe for you to participate. By volunteering you may help researchers: About. This is a Phase I study to determine the maximum tolerated dose (MTD) and/or recommended phase II dose of D2C7-IT (D2C7 Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent World Health Organization (WHO) grade III and IV malignant glioma patients, and/or to … The study team will also explain the purpose of the study and what will happen while you are in it and will answer any questions you have. Clinical Trials Duke Radiation Oncology’s coordinated team approach provides patients with sophisticated radiotherapy treatment planning and delivery. Clinical trials and research are made possible with the support and participation of study volunteers. Duke Recruitment Innovation Center, Copyright © 2004-2021 Duke University Health System, How to Participate in COVID-19 Clinical Trials, Cómo Participar en Ensayos Clínicos para COVID-19, Preguntas Frecuentes Sobre Estudios de Vacunas Para COVID-19, Guidance for Research Participants During COVID-19, Participating in a Clinical Trial or Study, Learn more about how the human body and mind work, Completing a questionnaire about health or behaviors, or answering questions in an interview with researchers, Donating a tube of blood or a tissue sample, Taking part in a clinical trial to find out if new therapies are safe and effective, Helping researchers understand how the healthy body works, The chance of that risk or harm happening. What kind of tests and procedures will be done to me during this study? For questions regarding cancer trials at Duke, please contact the Duke Recruitment Innovation Center via email or call 919.681.5698. From the administrative staff to your attending physician, we want your relationship with Duke to be as professional, courteous and successful as possible. Will you tell me about my personal results? She has served as an investigator in federally funded clinical trials … How do they compare with standard treatment? Phase: N/A Principal Investigator: Thomas Polascik Sponsor: Genomic Health, Myriad Genetics Contact: Denise Lech Phone: 919-681-7348 Reference Number: 00070017 Clinical Trials: N/A. Per Duke Policy, studies that meet the following criteria must be registered prior to receiving institutional approval in eIRB: Duke Investigator-initiated Applicable Clinical Trials; Duke Investigator-initiated studies that meet FDAMA criteria; NIH-funded interventional clinical trials (when Duke is the primary grant awardee) There are more than 200 clinical trials currently being conducted at the Duke Eye Center. Will this study require extra time or travel from me? The Ophthalmology Clinical Research Unit (CRU) oversees clinical research activities in various subspecialties including cornea, glaucoma, oculoplastics, retina, pediatric ophthalmology, and neuro-ophthalmology. Participating in a Clinical Trial or Study Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future. If this is a clinical trial, what phase is it? Clinical research can have risks, just like routine medical care and the activities of daily living. Each type chooses to participate for different reasons. You can also download a PDF of the questions below and print it before you meet the study team. Trials for the following conditions are currently available. However, they wouldn't exist without the people who volunteer to participate. We offer unprecedented access to clinical trials. When considering whether to participate in a clinical trial, it’s important to understand: The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team. Explore 367,846 research studies in all 50 states and in 219 countries. Types of participation can include: Our doctors and providers offer many opportunities for you to participate in clinical research. What were the results of earlier studies of this treatment? Home Clinical Trials at Duke Clinical Trials Directory. If … The Duke Cancer Institute (DCI) wants to assure our patients that the safety of our patients, their loved ones, our team members and the community at large remains our highest priority. The Department of Neurology is a national leader in clinical trials for multiple sclerosis, Alzheimer's disease, and other neurological conditions. Kidney Transplantation. For questions regarding cancer trials at Duke, please contact the Duke Recruitment Innovation Center via email or call 919.681.5698. On Friday of last week, the US Department of Health and Human Services published a long-awaited final rule (PDF) that governs the registration and data reporting for clinical trials with ClinicalTrials.gov.The final rule and an accompanying complementary policy issued by the National Institutes of Health … Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you. Staff; Visiting Research Scholars. DUCIMAS - Duke Cancer Institute Multidisciplinary Active Surveillance (DUCIMAS) Cohort Study. The following list shows the current clinical research trials being conducted in our division and the Duke researchers associated with the respective initiatives. How could the study treatment affect my daily life? Patients can enroll in clinical trials only after preclinical studies … Duke University Center for International and Global Studies. Almost all treatment methods currently available are the product of clinical trials. These efforts ensure our patients receive more personalized treatment options. Search. While some of the risks are minor, other risks are more serious. Email to Participate andrew.bouffler@duke.edu. Are there reasons the study might be stopped early? Hypertension. Researchers use a list of rules called eligibility criteria to decide who is eligible to be in the study. Search for clinical trials and health research studies at Duke Health locations. “Inclusion criteria” are factors that allow someone to be included in the study. 4.) Services include study design, clinical operations, statistics, data management, regulatory support, safety surveillance, and clinical … Will you tell me the overall study results when it is completed? Thank you for looking to Duke for your COVID-19 research information! We are closely monitoring this rapidly evolving situation and are implementing all necessary precautions to prevent the spread of infection. Search . How do they compare with what I would receive if I don’t join the study? However, they wouldn't exist without the people who volunteer to participate. Be included in the informed consent document you will need to sign before you decide allow to... Who is eligible to be seriously injured or die from complications related clinical. 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