What is clinical research?
Clinical research involves experimental studies to determine the safety and effectiveness of medical treatments. Clinical trials rely on the participation of volunteers and involve a research team which directly observes the volunteers (also known as research subjects) and collects data about the safety and potential benefits of a medical intervention. Examples of medical interventions include medications, tests and medical devices.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations including medical institutions, pharmaceutical companies, foundations, physicians and federal agencies such as the National Institute of Health (NIH) and the Department of Veteran's Affairs (VA).
Is clinical research right the right way to proceed?
Participating in a clinical research trial allows one to take a more active role in his/her medical health as well as potentially having access to treatments that are not available to the general public. While there may or may not be direct benefits to a participant in clinical trials, participation also affords an opportunity to assist in the future of medicine.
Who can participate in a clinical trial?
There are many different types of people who become involved in research. Some individuals are healthy volunteers while others may have known illnesses. Each clinical trial has certain guidelines about who can participate; these are called inclusion and exclusion criteria. Inclusion criteria are those factors which allow a person into the study and exclusion criteria are those that disallow a participant in the trial. Inclusion and exclusion criteria are very important as these guidelines are used to ensure the safety of the participants. It is also important to note that being included or excluded from one trial does not mean that a person may not be eligible for a different trial.
What should a person consider before participating?
Potential participants should know as much as possible about the clinical trial and should also feel comfortable asking a research team any questions they may have. The following is a list of questions that may be helpful in a discussion with a research team.
- What is the purpose of this study?
- What type of tests and experimental treatments are involved?
- What are the responsibilities of participants who enroll in the trial?
- Has there been previous testing done with this treatment?
- What are the potential benefits and risks of participating in this trial?
- How do the possible risks, side effects and benefits in the study compare with current treatment options?
- What are treatment options if there is no participation in the trial?
- How long will the trial last?
- Who will pay for the study?
- Are there any out of pocket expenses for participants?
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having a health care provider work with a research team, the participant may ensure that other medications and/or treatments will not conflict with the study protocol.
What are the benefits and risks of participating in a clinical trial?
There are both benefits and risks associated with clinical trials.
A participant may benefit from:
- Playing an active role in his/her own health care
- Gaining access to new treatments that are not available to the general population
- Helping others (family members as well as the general populace) by contributing to the advancement of medical research
There also may be risks with clinical trials:
- The treatment may not be effective for the participant
- Participation in a clinical trial may require more time than would be involved if only a course of non-protocol treatment was chosen
- Drug side effects are commonly referred to as adverse events in research. Adverse events can be anticipated (known to occur from previous phases of testing) or unanticipated complications which are side effects that were not anticipated.
Since risks are anticipated in clinical research, the Institutional Review Board (IRB) is very interested in the risk/benefit analysis. The IRB ensures the potential benefits of the research far outweigh the potential risks involved. (The IRB is discussed below.)
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The research team follows the protocol when conducting the trial. Information such as the purpose of the trial, inclusion/exclusion criteria and the schedule of tests and procedures are found in the protocol.
What is an informed consent?
Informed consent is the process of learning all the important facts about the trial before you decide whether or not to participate. Before any study procedures begin, the doctor and research team will explain the trial in full detail so that the participant is able to make a fully informed decision. The informed consent document includes details about the study, including the purpose, length of the trial, required procedures and key contacts. Potential benefits and risks are explained in this document. Participants are given a copy of this document and are encouraged to take the document home to read and review, as well as to prepare questions for the study team, before the document is signed and the trial is begun. The informed consent is NOT a contract and a participant may withdraw from a trial at any time.
What is a placebo?
A placebo is an inactive treatment that has no treatment value. It is commonly referred to as a "sugar pill". In clinical trials, experimental treatments are often compared with placebos to test the treatment's effectiveness. Subjects in the control group receive a placebo and subjects in the treatment group receive the active drug/treatment.
What is the Institutional Review Board (IRB)?
An IRB is a group of volunteers that serves on a committee to ensure that a trial is ethical and that the rights of study participants are protected. The committee may be comprised of physicians, nurses, pharmacists and community advocates. Every clinical trial in the U.S. must be approved and monitored by an IRB to make sure the risks are as low as possible and are worth the potential benefits. It is federal regulation that the IRB approves the trial initially and provides periodic reviews of the findings throughout the trial.
How will a participant's private information be protected?
Every effort is made to keep a participant's personal information confidential. Each subject is given a study number as an identifier (ID). When communicating with the sponsor/sponsor's designees, personal information is removed and a participant is identified only through his/her study ID. However, a participant's personal information may be disclosed if required by law. When the results of the research are published or discussed in conferences, no information will be included that might reveal a participant's identity.
The only people who will know that a person is a research subject are members of the research team and, if appropriate, your physicians and nurses. No information about, or provided by a participant during research, will be disclosed to others without the participant's written permission, except if necessary to protect the participant's rights or welfare (e.g.,if the participant was injured and in need of emergency care).
Clinical research at Neurological Associates of Albany, P.C. (NAA)
NAA has been involved in clinical research for over 30 years. Our practice has conducted over 125 successful clinical trials and has played a significant role in the investigation of all four drugs currently approved by the Federal Drug Administration (FDA) for the treatment of Alzheimer's disease. At NAA we believe our dedication and commitment to clinical trials allows us to provide you, our patients, with the most cutting-edge technology and most effective treatments presently available. We believe our patients deserve access to ground breaking new treatments and discoveries in Alzheimer's disease. Clinical trials many times lead to new therapies, techniques and devices that improve the quality of life and, ultimately, may also extend life. Participating in research proffers the advantage of knowing about treatment options before those options are available to the general public.