FAQs

A clinical trial is a medical study focused on new therapies, vaccines, or new ways of using known treatments. Clinical trials (also called research studies) determine if new drugs or medical devices are safe and effective.

Participants gain access to new research treatments before they are widely available and help others by contributing to medical research. Participants receive free high-quality care and may receive free medications and are compensated for their time.

All clinical trials have guidelines for who can and cannot participate. Criteria are based on age, gender, disease stage, previous treatment history, and more. Some studies seek participants with specific illnesses or conditions that need to be studied in a clinical trial, while others only need healthy participants.

Every trial has different patient activities (things patients do or complete as part of the trial). In our trials, these often include attending study appointments, tracking symptoms, taking study medication, or using study a study device, and providing information to evaluate the effectiveness of the product being investigated. Clinical trial teams including doctors, research staff, and other health care professionals, check participants' health, give specific instructions, monitor participants, and follow up after the trial. Some trials involve more tests and visits than others – all trials feature a dedicated research team. 

Familiarize yourself as much as possible with your clinical trial and informed consent documents and feel comfortable asking the team what you can expect. The following questions might be helpful to discuss with your trial team. 

• What is the study's purpose?

• Who is going to be in the study?

• Why do researchers believe the treatment being tested may be effective?

• Has the treatment been tested before?

• What kinds of tests and treatments are involved?

• How do the study's possible risks, side effects, and benefits compare with my current treatment?

• How might this trial affect my daily life?

• How long will the trial last?

• Who will pay for the treatment?

• Will I receive payment or reimbursement for expenses?

• What long-term follow-up care are included in this study?

• How will I know the treatment is working?

• Will the results of the trials be provided?

• Who will oversee my care?

Yes. As most clinical trials provide short-term treatments for a designated illness or condition, they do not provide extended or complete primary health care. A healthcare provider does oversee the study and works with research team to ensure that other medications or treatments will not conflict with the protocol.

Side effects refer to any undesired effects of a drug or treatment. Adverse effects vary widely and depend on the medication or device that is being evaluated in each study. Specific information about side effects is included in each study’s informed consent.

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

• Gain access to new research treatments before they are widely available. 

• Obtain expert medical care at leading health care facilities during the trial. 

• Help others by contributing to medical research. 

 While all trials help drive results, there are certain realities to trial participation you should be aware of.  

• Treatments may have unpleasant, serious, or even life-threatening side effects. 

• The treatment may not be effective for the participant. 

• The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, or complex dosage requirements. 

Yes. A participant can leave a clinical trial at any time. However, when withdrawing, a participant should inform the research team about their withdrawal and reasons for leaving the study.

Clinical trial ideas often come from researchers. After researchers test new therapies or procedures in the laboratory, the treatments with the most promising results move on to clinical trials. During a trial, more information is gained about treatments and their risks. 

Clinical trials are supported by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA).

Informed consent is not a contract; it is the process of learning key facts about a clinical trial before deciding to participate or not. The Informed Consent Form helps participants decide whether to proceed with a trial by providing information that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits can also be found in informed consent documents.

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

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

Control groups are the standard against which investigational observations are evaluated. In many clinical trials, a group of patients will be given an investigational drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Source:  clinicaltrials.gov 

Clinical trials progress in a series of phases – each phase is designed to answer a different question.  

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety and determine a safe dosage range and any side effects. 

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. 

Phase III: The drug or treatment is given to large groups of people to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect on various populations and any side effects associated with long-term use. 

 Source: http://www.nlm.nih.gov/services/ctphases.html