What should I expect?
Clinical trials consist of office visits similar to visits you would make to your own doctor and may include EKGs, x-rays, pulmonary function tests, physical examinations and labwork. Each trial consists of procedures specific for that trial. All study related procedures and study medication are provided. Each trial has its own specific requirements that must be met to be in the study. Trial participants are treated professionally and with respect. Participants receive our personal attention. They may receive a payment to cover travel expenses and for time spent in the study.
All studies require a consent form to read and sign. The informed consent provides you with information about the study. It describes the study, the schedule of visits, what is expected of you, procedures that will be done, the name and phone number of a person you can contact with questions or problems, the amount of monetary compensation, and a discussion of any potential risks and benefits. You are encouraged to show the consent form to your primary care physician. All your questions should be answered before you sign the informed consent and no study procedures will be done before the informed consent is signed.
Your decision to take part in a research study is voluntary at all times. If you decide not to participate in the study, or if you decide to withdraw from the study before it is complete for any reason, there will be no penalty to you. If you are a patient of our medical practice, your decision not to participate in a research study or to withdraw from a study will not affect your medical care from our practice in any way.
Are there different types of clinical trials?
Clinical trials are done in four phases. Phase I is the first phase of testing. These studies use healthy volunteers, are short-term and establish the safety and tolerance of the medication. Phase II studies are short to medium length and use volunteers with the appropriate disease for the medication being studied in order to define medication dosages. Phase III studies are the last studies done before the medication is submitted for approval. Phase III studies vary in length from several months to several years and use many volunteers with the appropriate disease for the medication being studied. These studies determine the medication’s safety and effectiveness with the selected dose in a large sample of volunteers and establish guidelines as to how the medication should be used. Phase III studies usually include a placebo (sugar pill) which means that some patients are not on active medication. Phase IV studies are conducted after the medication has been approved. Phase IV studies continue to monitor the safety of the medication in large groups of volunteers. AAIR Research conducts Phase II, III, and IV studies, with the majority being Phase III studies.
Is there a difference between a “research study” and a “clinical trial”?
We use these terms interchangeably, as generally speaking for our purposes they mean the same thing.
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:
• What is the purpose of the study?
• What is the duration of the study?
• What tests and procedures are part of the study?
• How will my condition be monitored?What is the background of the principle investigators?
• Who are the staff involved involved in my care during the study?
• What are the risks involved?
• If the treatment works, can I continue to use the medication?
Also, please see our Glossary of Terms to learn more about research.
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:
• Objective or purpose of the study
• Study duration
• Required procedures
• Risks and potential benefits
• Key contacts
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.
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.
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 apply online or call and speak with one of our staff. We 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 our database for notification about upcoming trials.
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.
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.