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 guidelines

In 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 trials

Ask 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 trials

Astellas 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
  • Women's Health Vasomotor Symptoms (hot flashes) associated with menopause
Astellas maintains a searchable database of its clinical trials here. People who are interested in joining a trial can search for Astellas trials that are evaluating treatments for specific diseases, and for trials with sites in their geographic area.

How to determine if you qualify for a clinical trial

Every clinical trial has a list of eligibility criteria – these are the rules that explain who can and cannot take part in the clinical trial. These rules are used to make sure the trial includes people who may benefit from the treatment, if approved, and to ensure that people who do participate are not exposed to avoidable risks. Eligibility criteria are specific to each clinical trial. They may be based on age, sex (at birth), medical history, current health status, type and stage of a disease, previous treatment history, and other medical conditions. For example, if a new drug was being developed to improve the outcome for people with metastatic breast cancer who have not been helped by other treatments, then the eligibility criteria will specify that people can join the trial only if they have metastatic breast cancer AND they have already tried certain other treatments with little or no success. A person who wants to join the trial might meet the eligibility criteria for the disease under study, but they might also have another medical condition – such as a heart problem – that might put them at greater risk of harm. Participants might also be excluded from a trial if they are allergic to any of the ingredients in the trial drugs, if they are pregnant, or if they are unwilling or unable to follow the expectations for participants outlined in the research protocol. Some clinical research trials seek participants with illnesses or conditions to be studied in the trial, while others need healthy participant volunteers. It is important to note that eligibility criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. Enrolling participants with similar characteristics helps ensure that the results will be due to what is being studied and not other factors. This helps researchers achieve accurate and meaningful research results.