We are trying to give you answers to some common questions about clinical research. We strongly recommend that you also do additional investigation to learn more about considering participation in a trial. Please see our Resources section to find other sources of information.
What is all this news I hear about clinical trials?
Clinical research is all around us. You may hear about it in the newspaper, on TV, on radio or via the internet and social networks. The research is sponsored by pharmaceutical companies, hospital organizations, and other public or private research organizations. And, the participants, who are volunteers, help us to gain answers to specific health questions.
What are clinical trials?
They are research studies conducted according to a plan called a protocol. A protocol describes what types of patients may enter the study, the schedule of tests and procedures, drugs, dosages, and length of study, as well as the anticipated outcomes to be measured. Carefully conducted clinical trials are the mechanism to evaluate the safety and effectiveness of investigational drugs.
There are different types of clinical studies—Phase I to Phase IV. Clinical trials can vary in size from a single site in one country to multi-center trials in multiple countries.
Phase I is where researchers test an investigational drug for the first time in humans by administering it to a small number of healthy people to evaluate its safety, determine a safe dosage range and identify side effects.
Phase II is where the investigational drug is given to a larger number of people who have a particular disease or condition to assess how well the drug works and to further evaluate its safety, as well as to continue Phase I safety assessments in a larger group of volunteers. This is often where a new drug fails or when the drug is discovered not to work as expected, or to have toxic effects or side effects.
Phase III is where several hundred to several thousand people with the appropriate disease or condition participate in multi-center studies, often in more than one country. During this phase, the investigational drug undergoes additional testing to further determine its safety and effectiveness, monitor sides effects and compare it to commonly used treatments.
Phase IV is when a drug already approved by prescription is tested to gather additional information on the benefits, risks, and use, for example in different populations whom the treatment was not previously tested.
How can I join a study?
Once you find a study you might be interested in, the best way to find out if you can join is to call and speak with one of the organizations, such as Chase Medical Research, performing the clinical trial. They have the knowledge on the requirements for participation. Each trial is very specific in its requirements and this is the best way to start the process.
Although you may not qualify for a particular study, if you want to be considered for future studies in a particular therapeutic area, you can ask to be put in an organization’s database for notification about upcoming trials.
Will I be able to see my own doctor?
Clinical research trials do not interfere with your relationships with your primary care doctors or specialists and you should maintain your relationships with your doctors. It is important that your own doctors communicate any treatment or changes in your health status to the clinical trial site staff while you are participating in the trial.
What is informed consent?
Choosing to participate in a clinical research study is an important personal decision. Informed consent is just one part of a larger process designed to help safeguard people who are interested in participating in a clinical study.
Informed consent is the process of learning the key facts about a clinical study before deciding whether or not to participate. This process continues throughout the study as a way of providing information to participants.
What information does informed consent cover?
If you think you may be interested in participating in a clinical study, an informed consent document will be presented to you. This document includes detailed information about the study, including but not limited to the following:
What happens next in the informed consent process?
After reading through the document and discussing its contents with the study doctor or staff, it is up to you to decide if you want to sign the document and participate in the study. The informed consent document is not a contract – even if you sign the document, you are free to leave the study at any time.
There are many other questions you may have or need to ask when you consider participation in a trial. We suggest that most questions be asked specific to the trial you are interested in joining. Some examples are below:
Also, please see our Glossary of Terms to learn more about research.