Understanding Clinical Research: Behind the Statistics

Start Date: 09/15/2019

Course Type: Common Course

Course Link: https://www.coursera.org/learn/clinical-research

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Course Syllabus

Welcome to the first week of this course. We’ll be tackling five broad topics to provide you with an intuitive understanding of clinical research results. This isn’t a comprehensive statistics course, but it offers a practical orientation to the field of medical research and commonly used statistical analysis. The first topics will look at research methods and the collection of data - with a specific focus on study types. By the end of the lectures you should be able to identify which study types are being used and why the researchers selected them when you are reading a paper.

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Course Introduction

If you’ve ever skipped over`the results section of a medical paper because terms like “confidence in

Course Tag

Clinical Research Statistics Statistical Analysis Statistical Hypothesis Testing

Related Wiki Topic

Article Example
Clinical research The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.
Understanding Animal Research The website provides extensive information, including statistics and videos, and news on animal research in the UK and beyond. In addition to the Understanding Animal Research Website the organisation has created AnimalResearch.Info a website that provides peer-reviewed, fully referenced information on animal research.
Clinical research Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Clinical research ethics Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics.
Clinical research associate The main function of a clinical research associate is to monitor clinical trials. The CRA may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a contract research organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. Clinical research associates also "assure the protection of the rights, safety and well being of human study subjects." Additionally, a CRA must "make certain that the scientific integrity of the data collected is protected and verified" and "assure that adverse events are correctly documented and reported."
Clinical research center The term "Clinical research center" (CRC) or "General clinical research center" (GCRC) refers to any designated medical facility used to conduct clinical research, such as at a hospital or medical clinic. They have been used to perform clinical trials of various medical procedures. The medical profession has had specific uses for CRC facilities, including awarding grants to support various types of research.
Parkinson's disease clinical research People with Parkinson's disease who are considering participating in clinical research have resources available to help them navigate the clinical research process.
Clinical research associate A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate.
Clinical research Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants.
Clinical research coordinator A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
Clinical research associate The Society of Clinical Research Associates (SOCRA) is a non-profit organization that is "dedicated to the continuing education and development of clinical research professionals". The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally-accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials. SOCRA provides training, continuing education, and a certification program. A CRA who is certified through SOCRA's certification program receives the designation of a Certified Clinical Research Professional (CCRP®).
Highland Clinical Research Facility The Highland Clinical Research Facility (HCRF) supports clinical research in the Highlands of Scotland. It was opened in 2009, and is a purpose built facility housed within the Centre for Health Science, adjacent to Raigmore Hospital in Inverness.
Clinical research associate The Canadian Association of Clinical Research Specialists (CAOCRS) is a federally registered professional association in Canada (Reg. #779602-1). The CAOCRS is a not-for-profit organization that promotes and advocates on behalf of its members in the field of Clinical Research and Clinical Trials. The CAOCRS has a comprehensive accreditation program including the Registered Clinical Research Associate (RCRA) designation, which is a professional title conferred by passing a qualifying exam.
Medical research Both clinical and pre-clinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term clinical trial. However, only part of the clinical or pre-clinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanistic understanding, diagnostics, medical devices and non-pharmaceutical therapies means that medical research is much more than just trying to make new drugs.
Lasker-DeBakey Clinical Medical Research Award Lasker-DeBakey Clinical Medical Research Award is one of four annual awards presented by the Lasker Foundation. The Lasker-DeBakey award is given to honor outstanding work for the understanding, diagnosis, prevention, treatment, and cure of disease. This award was renamed in 2008 in honor of Michael E. DeBakey. It was previously known as the Albert Lasker Award for Clinical Medical Research.
Parkinson's disease clinical research The Parkinson's Disease Foundation’s Parkinson's Advocates in Research (PAIR) program is a patient-based initiative that ensures people with Parkinson's disease have a role in shaping the clinical research process. By training advocates with Parkinson's disease to serve as patient representatives on clinical research advisory boards, the PAIR program aims to improve outcomes by helping researchers overcome and identify barriers in research that they may otherwise overlook. Participants in the PAIR program receive training through PDF's Clinical Research Learning Institute, an annual multi-day training that focuses on education via training sessions, clinical researcher led workshops, as well as interaction with study coordinators and representatives from both the government and the industry.
Clinical Practice Research Datalink The CPRD offers a range of interventional research services to facilitate the running of clinical trials.
Understanding Animal Research Understanding Animal Research (UAR) is a British advocacy group formed in late 2008 through the merger of the Research Defence Society and the Coalition for Medical Progress. Its main aims are to "broaden understanding and acceptance of the humane use of animals in biomedical research in the UK, to advance science and medicine".
Clinical Cancer Research Clinical Cancer Research is a peer-reviewed medical journal on oncology, including the cellular and molecular characterization, prevention, diagnosis, and therapy of human cancer. medical and hematological oncology, radiation therapy, pediatric oncology, pathology, surgical oncology, and clinical genetics. The applications of the disciplines of pharmacology, immunology, cell biology, and molecular genetics to intervention in human cancer are also included. One of the main interests of "Clinical Cancer Research" is on clinical trials that evaluate new treatments together with research on pharmacology and molecular alterations or biomarkers that predict response or resistance to treatment. Another priority for "Clinical Cancer Research" is laboratory and animal studies of new drugs as well as molecule-targeted agents with the potential to lead to clinical trials, and studies of targetable mechanisms of oncogenesis, progression of the malignant phenotype, and metastatic disease. The journal is published by the American Association for Cancer Research.
Clinical research ethics Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research.