Clinical Trials: Who Runs Them and How to Find Them
Clinical trials may be sponsored (or paid for) by a variety of organizations or individuals. These include pharmaceutical companies, government agencies (for example the National Institutes of Health, or Department of Veteran’s Affairs in the US), academic medical research institutions, voluntary groups, foundations, or individuals (such as physicians). The clinical trial sponsor oversees the trial, decides where the trial will take place, and analyzes the trial data. Clinical trials are conducted at medical facilities that have the experts and equipment needed to care for the trial participants. Some clinical trials have more than one location for performing different parts of the research. And some trials offer participants the option to complete certain activities from a more convenient healthcare facility or even from home using remote devices or other technology. From a participant’s perspective, the people “running” a trial are often the doctors, nurses, and other health care professionals at these trial sites. Regardless of who sponsors and runs a clinical trial, all clinical trials follow specific rules to help ensure that participant rights and safety are protected during the trial. A clinical trial cannot begin until the trial sponsor demonstrates that a plan is in place to make sure these rules are followed.
The importance of U.S. Department of Health guidelinesIn the United States, the U.S. Department of Health sets the rules for conducting clinical trials. Within the Department of Health, the Food and Drug Administration (FDA) oversees clinical trials to make sure they follow federal laws and FDA rules. These rules help ensure that the data collected in clinical trials is reliable and that participant rights, safety, and welfare are protected. While this is the case for the United States, in other countries the local government guidelines apply.
Where to look for clinical trialsAsk your doctor One of the best places to start looking for a clinical trial is by asking the people who already understand your diagnosis and which treatments might be right for you. Your doctor might be aware of clinical trials in your area, especially if he or she is a specialist in the field. Look online For the last 2 decades, one of the best resources for people seeking information about clinical trials has been ClinicalTrials.gov. This website is maintained by the U.S. National Library of Medicine (NLM) at the National Institutes of Health (NIH) and contains records of planned, ongoing, and completed studies in the United States and around the world. Public clinical trial registries are also available for patients in other countries around the world, including Japan, China and the European Union (EU). Individual trial sponsors, such as the NIH, academic research institutions, and pharmaceutical companies, such as Astellas, also have websites designed to connect people with trials that might be right for them. The NIH also funds a program called ResearchMatch, which helps connect people who are interested in clinical trials with researchers across the U.S. who might be able to help. Find a patient advocacy group with clinical trial resources Some patient advocacy groups maintain clinical trial registries designed to help patients with a specific diagnosis find trials that are right for them. The CureDuchenne Organization the GI Cancers Alliance are examples of such groups that have dedicated resources to help find clinical trials.
What to know about Astellas clinical trialsAstellas strives to improve the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas conducts clinical trials in:
- Cancer (oncology)
- Urology and kidney diseases/conditions
- Mitochondrial Based Therapies
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