What Is Clinical Research?
Clinical research is aimed at studying disease and the most effective ways that patients may receive care for their conditions. There are two types of clinical research.
Observational Studies
This type of research is focused on better understanding medical conditions and patterns in care. These types of studies may involve reviewing medical records, patient surveys, or possibly even biological samples such as tissue or blood provided by study volunteers. They answer these types of research questions:
- Who is at risk for the condition?
- How are patients usually diagnosed and what is the typical course of their condition?
- How are patients with the condition currently cared for and how can they best be cared for?
- What are the long-term outcomes of people with this condition?
Observational studies usually involve little to no risk.
Clinical Trials
This type of research is aimed at determining whether a medication, tool, or device is safe and effective for treating the condition. People volunteer to take part in clinical trials to answer these types of research questions:
- How does this potential new treatment affect the volunteer’s condition?
- What are the risks and side effects associated with this new treatment?
- How does this new treatment compare to other methods of treating the condition?
- Is the treatment safe and effective over time?
Clinical trials are conducted under close medical supervision according to strict rules to manage risks involved in participation.
Clinical research studies need volunteers of every age, health status, race, ethnicity and cultural background to take part. Diversity increases the chances of best understanding diseases and of developing treatments and procedures that are likely to be safe and work well in all people with the disease.
Frequently Asked Questions
Participating in clinical research may help to increase knowledge about a disease, develop new treatments, or even lead to a cure. Volunteers often feel very good about contributing their time and energy to this type of work. Clinical trials may offer people access to new treatments that they would not otherwise be able to receive under usual care. It is important to understand the possible benefits and risks involved in volunteering for clinical research.
There are multiple safeguards put in place to protect clinical research volunteers.
- Clinical research is regulated by the federal government. There are many rules in place that make sure the rights, welfare, and safety of clinical research volunteers are attended to.
- The work at every study location is monitored by an Institutional Review Board. This board is made up of both medical experts and members of the general public. They review the study plan and make sure that volunteers are protected from as much risk as possible. The IRB has the authority to approve, ask for changes, or disapprove clinical research.
- Some studies have Data Safety Monitoring Boards in place. These are groups of medical experts who monitor the clinical trials for any potentially serious safety concerns that may develop during the study. They have the responsibility to pause or stop the study if safety concerns arise.
- Clinical researchers are required to follow the strict safety rules of the study protocol. A protocol is a very detailed written plan for how the study will be conducted and how volunteer safety will be monitored.
- In all clinical research, volunteers receive a document at the very beginning called an informed consent. It outlines the clinical trial protocol and explains the details of the trial in plain language including:
- The purpose of the research
- The possible risks and benefits of volunteering
- The duration of the trial
- What you will be expected to do; including procedures and visits
- Clinical research studies are a means of improving our understanding of disease for developing safe and effective treatments. You can feel good about contributing to medical knowledge that helps others!
- If you participate in a clinical trial, you may get access to new drugs or treatments before they are available to others
- You may receive care at no cost. You may even receive compensation for your time and effort.
- You may receive testing to monitor for side effects
- Volunteering for clinical research may take more time and require more visits or testing than usual care
- If the research involves a treatment, it may not work
- The treatment may cause serious side effects
The clinical research protocol will spell out who can participate. These guidelines are called eligibility criteria. The factors that allow you to participate in a study may include age, the type and severity of your disease, previous treatment history and other medical conditions. Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.
- You have the right to receive a full description of the clinical trial details and what is expected of you. This is all described in the informed consent document. It also describes the potential risks and benefits for volunteering.
- You have the right to ask questions of your study team to make sure you understand what is expected of you. You may take as long as you need to decide whether or not to volunteer for a study.
- Once the study begins, you have the right to withdraw from the study. You may do this for any reason and at any time.
By agreeing to volunteer in a study, you are required to comply with the study protocol. This means that you agree to attend all visits, follow the testing and treatment schedule, and keep notes as required. You must tell the research team about any possible side effects, new medical problems, hospital visits, and new medications. It you do not follow the study requirements, you may invalidate the study results. Remember, you are free to withdraw from the study at any time.
- Ask your doctor or healthcare provider
- On the Uterine Fibroid Foundation website (link)
- Search for privately and publicly funded studies on www.clinicaltrials.gov