What is a study protocol?
Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol. The protocol explains what the study will do, how it will be carried out, and why each part of the study is necessary. For example, the protocol includes:
- The reason for doing the study
- How many people will be in the study
- Who is eligible to participate in the study
- What study drugs participants will take
- What medical tests they will have and how often
- What information will be gathered
Every doctor or research center that takes part in the trial uses the same protocol. This ensures that patients are treated identically no matter where they receive treatment, and therefore information from all the participating centers can be combined and compared.
How can I participate in a clinical trial?
In order to participate in clinical trials, patients must usually meet certain criteria. These criteria can include gender, age, severity of illness, lifestyle behaviors such as smoking or not smoking, or whether or not you are currently taking any medications or a particular medication. Some clinical trials require healthy volunteers. There is often a screening process where your eligibility is determined.
Patients usually hear about clinical trials from their health care providers. You can also find out about existing trials on the internet at sites such as http://www.centerwatch.com/ or http://www.clinicaltrials.gov/. To find out if you are eligible for any of the research trials conducted by the National Heart Lung and Blood Institute, click here and select "Heart and Vascular Diseases."
Before entering the trial, you will receive information about the clinical trial, explaining its process. Before you can participate, you must sign an informed consent form stating that you understand the process and voluntarily agree to participate. You will be told of any follow-up studies you may be needed to participate in and whether you are responsible for any costs associated with the treatment, such as a diagnostic test.
You can choose to leave the trial at any time because your participation is completely voluntary. To be included in the final results, participants should remain in the study for the full time and be available for follow-up studies. Often, you must live close to where the clinical trial is being conducted so that your progress can be monitored closely and you are readily available for follow-ups.
What is informed consent?
Informed consent is a process in which you learn the key facts about a clinical trial before deciding whether or not to participate. In addition to talking about these facts with the research doctor or nurse, you will be given a written consent form to take home and study. The consent form will include details about:
- what the study entails; what is being tested?
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have
Don't hesitate to ask questions. While informed consent begins before participation in a trial, you should feel free to ask the health-care team any questions at any point. Informed consent continues as long as you remain in the study.
What are the benefits of participating in a clinical trial?
There are several significant benefits to participating in a clinical trial. The treatment that you receive in a trial may not otherwise be available, and if the treatment is successful, study participants receiving it can be among the first to benefit from it. In addition, you will receive closely monitored medical treatment from a well-respected physician or hospital. Participating in a study should not affect your relationship with your primary health care provider. Some trials provide all treatments, tests, and medications at no cost, and others provide financial compensation to study participants.
What are the risks of participating in a clinical trial?
There are, of course, risks from any treatment or procedure. However, under federal law, every research trial with human participants has to be approved by a committee, known as an Institutional Review Board (IRB). The IRB is composed of volunteering physicians from a broad range of backgrounds and is responsible for ensuring that participants' rights are protected, that they are given adequate information about the study, and that the risk of harm is as low as possible.
Despite these measures, agreeing to participate in a clinical trial always comes with risks. For example, the treatment being studied may not be as effective as the current standard of care. Not every study participant actually receives the treatment—if a participant is in the control group, she may receive a placebo and thus miss out on the investigational treatment while in the trial. However, in most randomized trials, the control group is given the treatment or medication that is the current, accepted standard of care. An additional risk is that participants who receive the investigational treatment may experience side effects.
Why is it important for women to participate in clinical trials?
In general, women are underrepresented in clinical trials for heart disease-related drugs and treatments. The majority of these research studies have included only, or primarily, middle-aged men. It is only in recent years that it was questioned whether the results of these studies really applied to women. It is important for women to participate in research studies so that researchers can be sure that new medications and treatments work as well in women as they do in men before they are given to the population at large. Since 1990, the National Institutes of Health (NIH) has required that NIH-funded research trials include women, and since 1994, it has required that results be analyzed based on sex.1 Even so, it is still rare if more than 35% of participants in a clinical trial of heart-related treatments are women.
1. Wenger NK. You've come a long way, baby: cardiovascular health and disease in women: problems and prospects. Circulation. 2004;109:558-560.