- What is a clinical research study?
- What are the different phases of clinical research?
- Why would I want to be in a clinical research study?
- What are the potential benefits?
- What are the potential risks?
- Who sponsors a clinical research study?
- Who conducts a clinical research study?
- Who makes sure my rights are protected?
- What is an Informed Consent?
- Who can be in a clinical research study?
- What should I tell my doctor?
- What is a placebo? What does "double-blind" mean?
- Will I be guaranteed to receive the treatment?
- Will the drug be available after the study has ended?
- Will I be paid for my participation? What is a stipend?
- Does my participation in a study affect my medical insurance? Will my insurance be billed, or my participation in a study be reported to my insurance company?
- How frequent and how long are the visits?
- Can I continue my medication?
- What if I change my mind and want to quit the study?
- Can I participate in more than one research study?
- How can I volunteer for a study at your site?
- Where is the research conducted?
- What studies are being conducted at your site?
- What are the typical services provided by your site at no charge?
What is a clinical research study?
A clinical research study, or clinical trial, is a scientific study that tests the safety, effectiveness, and side effects of a potential new or investigational medical treatment, drug, or device. Research studies also test new uses or comparisons of known medications.
What are the different phases of clinical research?
The process of developing and getting a drug to market is extensive and lengthy. Prior to any human studies, Preclinical Testing is done. Once the investigational drug passes the preclinical testing, the drug is eligible to be submitted for approval by the FDA. The pharmaceutical company in charge of the development submits an Investigational New Drug Application (IND). The IND includes information such as:
—The chemical structure of the compound
—How the compound is manufactured
—How it is thought to work in the body
If the IND has not be rejected by the FDA, and has been approved by the IRB, then the drug can begin human trials.
There are four (4) phases of clinical studies:
Phase 1 studies take 20 to 80 normal, healthy adult volunteers, and study the effects of the drug in order to establish a safety profile, including the safe-dosage range. Phase 1 studies also investigate how a drug is absorbed, distributed, metabolized, and excreted by the body, as well as the duration of its effects.
Phase 2 studies are typically controlled studies involving 100-300 volunteer patients affected by the disease. The primary objective of a Phase 2 study is to determine the effectiveness of the drug.
Phase 3 studies involve many more volunteers (between 1000-3000), and the primary objective is to determine its efficacy compared to other established treatments, and identify any potential adverse reactions.
Phase 4 studies are the most expansive studies, the study population is much wider in scope than previous studies, allowing for a more general population to be studied. This gives researchers a clearer picture of how the drug will operate in the "real world".
Keep in mind there are many details that are not within the scope of this FAQ. If you would like more information, please go to The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective.
Why would I want to be in a clinical research study?
If you choose to participate in a research study, you will be contributing towards the development of new treatments and the generation of new knowledge regarding your condition. This information can not only help others who have the same condition, but can help future generations as well. You also receive some benefits that could be helpful in managing your condition.
What are the potential benefits?
By participating you can receive benefits such as:
—Access to study-related medications before the general public
—A better understanding of your condition and overall health
What are the potential risks?
There are risks, known and unknown, associated with research studies. They may include:
—There may be unpleasant and/or serious side effects resulting from the treatment
—The time and effort requirements may be significant
Who sponsors a clinical research study?
The sponsor can be a private organization (phamaceutical companies, academic institutions, voluntary/advocacy groups, etc.) or a government agency (National Institute of Health, U.S. Department of Defense, U.S. Department of Veteran's Affairs, etc.). Occasionally, an individual physician, or health care provider may contribute funding or support for a study.
Who conducts a clinical research study?
Research studies are conducted by the Primary Investigator (PI). In the context of medical studies, the PI is almost always a medical doctor, supported by research staff consisting of other doctors, psychiatrists, nurses, social workers, and other healthcare professionals. Research staff may be responsible for conducting the majority of study procedures, but ultimately, it is the PI's responsibility to oversee the proper conduct of the trial, and ensure volunteer safety.
Who makes sure my rights are protected?
There are many regulations in place to protect your rights and safety as a volunteer. The Food and Drug Administration (FDA) requires minimum standards to be met before further studies of the drug can be conducted, including general reviews to determine the legitimacy of the drug.
There is also an ethics review group called the Institutional Review Board (IRB) who is composed of doctors, nurses, and other members of the community. The IRB is responsible for reviewing all clinical research studies, and protecting the rights and safety of all volunteers.
In addition, the Informed Consent, presented before any study procedures are performed, is accompanied by the California Experimental Subjects Bill of Rights. The CA Experimental Subjects Bill of Rights outlines all the rights you have as a volunteer in a clinical research study.
For more information about the Institutional Review Board's role in a clinical study, please go to FDA Institutional Review Boards Frequently Asked Questions - Information Sheet.
What is an Informed Consent?
Informed Consent (ICF) is a process in which potential volunteers are given information about a clinical study. This information is intended to help volunteers decide if they want to volunteer for, or continue to participate in, the research study.
The ICF process should provide the volunteer with sufficient information for the volunteer to understand the risks of, benefits of, and alternatives to the study. In addition to the ICF document, the PI or a member of the research staff will answer any questions, and make any necessary clarifications to ensure volunteer understanding.
An ICF is almost always signed prior to the performance of any study procedures, showing that the volunteer understands the risks of, benefits of, and alternatives to the study.
Signing an ICF is not a contract, and the volunteer may withdraw from the study at any time, for any reason.
Who can be in a clinical research study?
Participation in a clinical study is limited by eligibilty criteria, which can be found in the protocol. Eligibilty criteria is distinguished by two categories. Inclusion criteria are the requirements that need to be met in order to qualify for the study. Exclusion criteria are restrictions on who can qualify for the study. In order to fully qualify for a study, all inclusion criteria and no exclusion criteria must be met. The PI and the Sponsor can make exceptions to the eligibility criteria on a case-by-case basis. However, exceptions are rare, and should not be expected.
Eligibility criteria are important because different studies have different needs. Some studies may require volunteers who have the illnesses or conditions under study. Other studies may require normal, healthy volunteers. Please understand that we cannot reveal any of the eligibility criteria, as that may indirectly affect the results of the study.
What should I tell my doctor?
What you wish to tell your doctor is up to you. If you wish to discuss your participation with your doctor, we will be happy to work in conjunction with your doctor or primary care provider. If you wish to keep your participation in the research study private, we will respect your wishes, and reveal only the information you want revealed.
However, while participation in a research study provides you with some medical products or interventions related to the illness or condition being studied, it is not intended to provide you with extended or comprehensive health care. By working with your regular health care provider, we can ensure that the study protocol will not conflict with any other medications or treatments being received.
What is a placebo? What does "double-blind" mean?
A placebo is a tablet or capsule with no active ingredients. A placebo is necessary in order to distinguish a placebo effect from a real effect. This is an important part of any FDA trial.
Double-blind means that both you and the medical staff conducting the research study are unaware of whether you are receiving a placebo or the investigational product. This is important to account for placebo effects and expectancy effects.
Both placebos and a double-blind design are standard practice in all clinical trials designed to show safety and efficacy of an investigational product.
Will I be guaranteed to receive the treatment?
Whether or not you receive the treatment depends on the design of the study. Some studies are cross-over studies, which means that you will receive both a placebo and the investigational product during the study. Others are not, in which you will be assigned to a treatment, and remain in that treatment until the conclusion of the study. The treatment you are assigned to is done randomly, and out of the control of the PI.
Will the drug be available after the study has ended?
If the investigational product is found to be beneficial, there is a chance that an open-label extension (OLE) study, or post-trial access (PTA), may be offerred. An OLE or PTA is not guaranteed and is offerred at the discretion of the study Sponsor.
Will I be paid for my participation? What is a stipend?
If you are enrolled in a study, a stipend will be provided to cover your time and expenses due to your participation in the study. Stipends are fixed amounts and vary according to the study. At our clinic, stipends are paid bi-monthly.
Does my participation in a study affect my medical insurance? Will my insurance be billed, or my participation in a study be reported to my insurance company?
No, your insurance provider will not be involved in any manner. Your participation in the study is completely voluntary and you will not be billed for any procedures. Furthermore, your participation in the study will be kept confidential. No third party will be informed of your participation, unless you specifically request it.
How frequent and how long are the visits?
The schedule of visits varys considerably from study to study. The length and frequency of your visits can be discussed with your CRC, and is addressed in the ICF.
Can I continue my medication?
It depends on the medication and the requirements of the study protocol. Some medications are restricted and may require authorization to continue use of the medication. Other studies may require you to discontinue a medication before and/or during the study. For more specific information, you will have to speak with a CRC about your individual situation.
What if I change my mind and want to quit the study?
Your participation in any study is completely voluntary at all times. If you wish to discontinue at any time, for any reason, it is your right to do so. This will be reiterated in the ICF as well as by your PI/CRC at the time of enrollment, but holds true for the duration of the study.
Can I participate in more than one research study?
Yes, you may participate in more than one study over your lifetime, but you may not participate in more than one research study that involves an investigational product at the same time. For further clarification, please contact a CRC.
How can I volunteer for a study at your site?
Just contact us! You can call us, email us, or simply visit us to get the process started. All of our contact information can be found here: San Francisco Clinical Research Center - Contact Us.
Where is the research conducted?
Most procedures are done on-site at the San Francisco Clinical Research Center. Some procedures may require travel to an off-site location, depending on the protocol of the study.
What studies are being conducted at your site?
Our active and enrolling studies are always changing. For the most up to date information, please go here: San Francisco Clinical Research Center - Clinical Trials.
What are the typical services provided by your site at no charge?
We offer complimentary Mini-Mental State Examinations (MMSE) and Free & Cued Selective Reminding Tests (FC-SRT) as a service to the community. We believe that early detection of potential dementia is critical in preserving cognitive abilities and Quality of Life. Please call our office to arrange an appointment.
If you have other questions that are not answered here, please feel free to contact us. We would be happy to answer any questions you may have.