Frequently Asked Questions (FAQs)

Who can participate in a clinical study?

All clinical studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical study are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria." These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical study, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical study, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a clinical study?

The clinical study process depends on the kind of study being conducted. The clinical study team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the study, give specific instructions for participating in the study, and monitor the participant carefully during the study.

Some clinical studies involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of studies, the participant works with a research team. Clinical study participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What are the benefits and risks of participating in a clinical study?

According to regulatory authorities, there are benefits and risks associated with participating in a clinical trial, including:

Benefits Clinical studies that are well-designed and well-executed are the best approach for eligible participants to:

Obtain medical care at health care facilities during the study
Help others by contributing to medical research

Risks

There may be unpleasant, serious or even life-threatening side effects to experimental drug.
The experimental drug may not be effective for the participant.
The study may require more time and attention than would a standard treatment, including trips to the study site, hospital stays or complex dosage requirements.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, most clinical research is federally regulated with built-in safeguards to help protect the participants.

The study follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical study progresses, researchers report the results of the study at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Plan ahead and write down possible questions to ask.
Ask a friend or relative to come along for support and to hear the responses to the questions.
Bring a tape recorder to record the discussion to replay later.

Every clinical study in the US must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that helps ensure that a clinical study is conducted in an ethical manner and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Does a participant continue to work with a primary health care provider while in a study?

Yes. Most clinical studies provide short-term investigational drugs related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can help ensure that other medications or treatments will not conflict with the protocol.

Can a participant leave a clinical study after it has begun?

Yes. A participant can leave a clinical study at any time. When withdrawing from the study, the participant should let the research team know about it, and the reasons for leaving the study.

Where do the ideas for studies come from?

Ideas for clinical studies usually come from researchers. After researchers test new investigational drugs or procedures in the laboratory and in animal studies, the experimental drugstreatments with the most promising laboratory results are moved into clinical studies. During a study, more information is gained about an experimental drug, its risks and how well it may or may not work.

What is a protocol?

A protocol is a study plan on which all clinical studies are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the study; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical study, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical studies, experimental drugs are are often compared with placebos to assess the experimental drug's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental drug.

What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical studies, one group of patients will be given an experimental drug, while the control group is given either a standard treatment for the illness or a placebo.

What is a screening process?

All potential clinical study participants must be evaluated by the study doctor to make sure they meet the eligibility requirements. Most clinical study screenings require a physical examination to assess height and weight, temperature, blood pressure, and blood and urine tests. Often, an electrocardiogram is conducted, which is a painless, noninvasive test that records the electrical activity of the heart.

It is also common for a screening to include blood and urine testing as well as other diagnostic evaluations.

What is meant by study design?

Many clinical studies are designed to prevent anyone (including study doctors, nurses, or participants) from affecting the study’s scientifically accurate results. Blinded studies are often designed so that participants do not know which study medication they are taking, so they can describe their reactions without being biased.

Single- and double-blind studies
In single-blind studies, only the participant does not know which study medication he or she was given.
In a double-blind study, doctors, nurses, participants, and other healthcare staff are not informed as well.

Some studies are placebo-controlled, which means that one group of study participants takes a placebo while another group takes an investigational medication. Other studies are active-controlled, where one group of participants receives a recognized effective treatment and the other group receives the investigational medication.

In a medical emergency, it is always possible to find out which study medication group a participant has been assigned to, and to determine which study medication the participant has been taking.

Open-label studies
In open-label studies, both the researchers and participants know which drugs are being used.
The ELOQUENT Multiple Myeloma Program is “open-label,” which means that both you and your study doctor will know which study drugs you are receiving.

What is randomization?

Randomization occurs when a participant is selected by chance (not by choice) to join a study treatment group. This is similar to being chosen by flipping a coin. For example, if an investigational medication is being compared to a currently available drug or placebo (an inactive drug), there may be 2 study groups. One group of participants may receive the investigational medication, while the other would receive a placebo.

The standard drug may be covered with a capsule or the placebo will be made to look the same as the investigational medicine so that study participants are unable to tell the difference between the drugs.

Will there be any cost to me if I participate in a clinical study?

Study medications, procedures and tests, as well as visits, may be provided without cost to participants. Information about costs is included in the informed consent form and the study doctor will answer any questions about cost that you may have.

I am not eligible to participate in this study – where can I learn about other studies?

Click here to visit the study sponsor's Patient and Caregiver Clinical Study website, Bristol-Myers Squibb Study Connect
http://www.bms.com/StudyConnect/Pages/Home.aspx

I am not eligible to participate in any clinical studies sponsored by Bristol-Myers Squibb – where can I learn more about other studies?

Visit www.clinicaltrials.gov to learn about studies not listed on the Bristol-Myers Squibb Study Connect website.

Why can't I find a study listing I previously saw on Bristol-Myers Squibb Study Connect?

When a study has completed enrolling participants, additional people are not permitted to enter the study. At that time, the study listing is automatically removed from Bristol-Myers Squibb Study Connect. Studies that have completed enrollment can be found on the Bristol-Myers Squibb Clinical Trials Transparency website at http://www.bms.com/clinical_trials/Pages/home.aspx or visit www.ClinicalTrials.gov.

Click here to visit the study sponsor's Patient and Caregiver Clinical Study website, Bristol-Myers Squibb Study Connect