What is clinical research and why is it done?
Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn:
- How the body works
- How illness develops in people, such as how diseases get better or worse over time
- How the body handles a possible treatment
- Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness
The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.
What are the types of clinical research?
There are 2 main types of clinical research:
- Clinical trials, also called interventional studies
- Observational studies
Both may try to learn more about an intervention, which may be a drug, behavior, or medical device. The main difference is clinical trial participants are assigned to get an intervention, but observational study participants are not assigned to get an intervention.
Clinical trials
Clinical trials are research studies in which researchers assign participants to get one or more interventions to test what happens in people. Because of this, clinical trials are also called interventional studies. Often, the intervention is investigational, which means it is not approved for doctors to prescribe to people.
In some clinical trials, researchers assign participants to interventions randomly. This means that researchers assign the participants by chance. Usually, participants (or their doctors) don’t choose what intervention they will get when they join a clinical trial.
Observational studies
Observational studies are research studies in which researchers simply collect information (called data) from participants or look at data that was already collected. The data may be about participants’ health, habits, or environments. In observational studies, researchers do not assign participants to get an intervention. If there is an intervention, participants were already using it as part of their regular health care or daily life.
Often, researchers use observational studies to look at (observe) the different ways people behave and how it affects their health. Some observational studies use patient registries. A patient registry is an organized collection of data that patients agree to give. Researchers can use a patient registry to quickly access data provided by hundreds, or thousands, of similar patients.
What about safety and chance of harm (risk) during clinical research?
All studies involve some level of risk or harm to participants. Because of this, there are people and systems in place to look out for participants’ safety.
The possible risks of taking part in clinical research include:
- The chance that participants will have a side effect or other health problem during a study (also called an adverse event)
- Participants may not get the intervention being tested in a clinical trial – instead, they may get the standard treatment or no treatment at all
- The intervention being tested may not work or may not work better than the standard treatment
- The study may require more time and visits than their regular health care.
All clinical research involves some risk. Different kinds of studies have different amounts of risk to participants. For example, the amount of risk may be the same or different as participants’ regular health care.
How does joining a study affect participants’ usual health care?
In most studies, participants can keep seeing their regular doctors. If needed, the research staff will work with participants’ doctors to make sure that being in the study will not cause problems. In some studies, participants may have to change or limit their usual health care, such as stopping other medicines they take.
What if participants have health problems during clinical research?
Research staff will explain what to do if participants have health problems during the study. Usually, research staff ask participants to report health problems to them right away. Research staff include doctors and nurses who will work with participants and the participants’ regular doctors to address the problem.
A group of experts may also oversee what is happening in the study. If they have a safety concern, they contact the researchers right away.
If very serious health problems happen to participants during the study, the researchers may stop the study.
Participants can choose to leave the study, called “withdrawal”, at any time and for any reason. If they decide to leave, they can talk to the research staff to do so safely.
After clinical research, how do researchers share what they learned?
After the researchers analyze the data and the study is complete, researchers can share the study results. Study results summarize group data collected from all participants. These results can be published in research journals, on the internet, and on ClinicalTrials.gov. In some cases, researchers may list data from individual participants, but not in a way that allows readers to identify the participant.
If the researchers tested a new drug or treatment that they want to make available to all patients, they submit the data and results from clinical trials to the FDA. Experts at the FDA will look at the data from the clinical trials and decide whether to approve the treatment for use in people with a certain condition.
Usually, researchers need many studies before changing the way doctors prevent and treat illnesses.
If you or a loved one may have been harmed as a result of a clinical trial in the United States, you should promptly find a medical malpractice lawyer in your state who may investigate your clinical trial injury claim for you and represent you or your loved one in a clinical trial injury case, if appropriate.
Click on the “Contact Us Now” tab to the right, visit our website, or call us toll-free in the United States at 800-295-3959 to find medical malpractice attorneys in your state who may assist you.
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