Conducting clinical trials requires specialized knowledge in order to write study protocols, conduct drug safety activities, and monitor the trials. Clinical research professionals are required to demonstrate that clinical work has been performed in compliance with regulations and operational practices. Standard operating procedures (SOPs) are designed for that purpose. SOPs are a set of instructions that define and standardize procedures in clinical trials. They clearly document the rules of procedure to maintain consistency and accuracy. Students in clinical research training explore the global and national healthcare systems, including health care legislation, guidelines, and standard operating procedures (SOPs). With an understanding.. READ MORE »
Statistical analysis is a critical component in an evidence-based clinical research process. Statistical analysis is the process of collecting and analyzing data gathered to determine trends and patterns. Using statistical analysis allows researchers to establish whether the data they’ve obtained supports their research question. When approaching a clinical research study, it’s important to start the process with a statistical analysis plan (SAP), choosing the statistical methods which are appropriate for the study at hand. Despite its importance, developing a statistical analysis plan for clinical research can be a complicated task, especially if your research framework isn’t totally air tight. If.. READ MORE »
Clinical trials are essential for the development of new treatments. With this in mind, it becomes even more important to make sure sensitive data is protected in the process. This is especially true when these trials rely increasingly on digital file storage. Volunteers in these trials trust researchers’ ability to keep their data safe and secure, as well as protect their privacy. This can help prevent avoidable issues from occurring at any phase in the process, and reassure participants that their sensitive information is safe, secure, and confidential. By understanding the importance of protecting sensitive data from the view of.. READ MORE »
In the field of clinical research, pharmacovigilance represents the analysis and monitoring of drugs and medications to prevent adverse effects. In order to ensure drug safety and prevent adverse events, Health Canada has generated a list of strict practices and guidelines that must be followed by clinical research professionals and drug manufacturers. The health authority also has an inspection program in place to provide independent oversight and evaluation of manufacturer adherence to mandated reporting of adverse drug reactions, and of any efficacy failures found in new drugs. To understand more on the need to employ pharmacovigilance practices, and what some.. READ MORE »
The importance of time management in clinical trials can’t be understated, with delays and missed deadlines quickly maxing out budgets, and having the potential to terminate trials altogether. Many missed trial deadlines, according to some research, occur due to poor project management and inefficient use of time rather than poorly executed scientific approaches. With this in mind, it makes sense for students of clinical research training to get into the habit of practicing superior time management strategies now, before they begin working professionally. Here are a few basic yet effective approaches to follow. Set Your Goals When you’re taking your.. READ MORE »
The career of someone involved in clinical research has a lot to do with pharmaceutical and health products, but this isn’t only limited to the prescription medications that may initially come to mind. Natural Health Products (NHPs) are substances that don’t require a prescription to purchase, and includes, but is not limited to: Vitamins Minerals Herbal remedies Homeopathic medicines Probiotics Chinese traditional medicines Ayurvedic traditional medicines According to a 2010 Ipsos-Reid survey,.. READ MORE »
Before diving into primary research, a responsible researcher will examine, evaluate, and synthesize what has already been published on the subject by writing a literature review. This article provides a succinct overview of the relevant findings on a given topic and helps researchers identify relevant frameworks for their upcoming project. Although many researchers are eager to launch new clinical trials after completing their training, it is imperative to conduct a literature review first. Understanding literature reviews will help you maximize originality, relevance, and impact in your future research career. What Is the Purpose of Literature Reviews After Clinical Research Training?.. READ MORE »
When we read health-related statistics such as 1 in 8 Canadian women are expected to develop breast cancer, or that men are typically diagnosed with heart disease around 10 years younger than women in Canada, we have biostatistics to thank for these important conclusions. Biostatistics involves analyzing and interpreting data drawn from health sciences in order to better understand public health concerns such as chronic disease, cancer, and AIDS, as well as critical concepts such as human development and the relationship between genetics and the environment. Biostatistics also plays a key role in many scientific fields, including: biology clinical medicine.. READ MORE »
Over the past decade Canada has made significant investments into clinical trial health research through educational institutions, research centres, and hospitals. These investments are intended to maintain Canada’s status as a top site for global pharmaceutical companies to do clinical trial research. It is therefore important for anyone interested in clinical research to understand the roles of different branches of statistics in this area of study. From research and development to post-marketing monitoring of pharmaceuticals, clinical research relies on statistics. To test hypotheses, answer questions, and adhere to regulations, a study or trial must be designed to gather the appropriate.. READ MORE »
As cancer treatment research works towards drugs that have anti-aging properties, this may help treat or prevent the spread of growths. Since poorly aging cells can enable the development of the disease, this could act as an effective treatment. The process of aging in cells is called senescence. Senescence is normal and is the body’s way of getting rid of older, damaged matter. However, when the process is not taking place normally, it is thought that this can allow tumors to grow. Drugs that eliminate poorly aging cells are called senolytics. Read on for how scientists have discovered a pre-existing.. READ MORE »
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