Caring for Carcinoid Foundation - Carcinoid Clinical Trials

"A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective."

Clinical Trials - Cancer Talk Show (video)

Cancer Clinical Trials: The In-Depth Program - NIH

Clinical Trials - National Library of Medicine (multimedia tutorial)

Questions and Answers about Clinical Trials - FDA

What are the Phases of Clinical Trials?

A new drug typically passes through 3 phases of clinical trials before receiving approval, according to the National Cancer Institute:

"Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:

Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide."

Participation

What are the Potential Benefits and Risks?

The potential benefits and risks of a clinical trial, according to the National Cancer Institute, are the following:

Potential benefits include:

Health care provided by leading physicians in the field of cancer research

Access to new drugs and interventions before they are widely available

Close monitoring of your health care and any side effects

A more active role in your own health care

If the approach being studied is found to be helpful, you may be among the first to benefit

An opportunity to make a valuable contribution to cancer research

Potential risks include:

New drugs and procedures may have side effects or risks unknown to the doctors

New drugs and procedures may be ineffective, or less effective, than current approaches

Even if a new approach has benefits, it may not work for you

Should I Enter a Clinical Trial?

Entering a Clinical Trial: Is It Right for You? - Dana-Farber Cancer Institute (video)

Entering a Clinical Trial: Is It Right for You? - Dana-Farber Cancer Institute

Taking Part in Clinical Trials: What Cancer Patients Need to Know - NIH

Clinical Trials: What You Need to Know - American Cancer Society

Clinical Trials: A Chance to Try Evolving Therapies - Mayo Clinic

Who is Eligible to Participate in a Clinical Trial?

Eligibility criteria are unique to each clinical trial, as explained by the National Cancer Institute:

"Each study has its own guidelines for who can participate, called eligibility criteria. To ensure the strongest results, researchers want study participants to be alike in key ways. Examples of eligibility criteria for a treatment trial might be a particular type and stage of cancer, age, gender, or previous treatments. The eligibility criteria are included in the study plan. To find out if you are eligible for a particular study, talk to your doctor or the doctor or nurse in charge of enrolling patients for the study."

Patient Involvement in Research Studies - Health Politics (video)

What is Informed Consent?

Informed consent by a patient is required before participating in a clinical trial, according to the National Cancer Institute:

"Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about:

the study approach

the intervention given in the trial

the possible risks and benefits

the tests you may have

Don't hesitate to ask questions until you have all the information you need. While informed consent begins before you agree to participate in a trial, you should feel free to ask the healthcare team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want -- before the study starts or at any time during the study or follow-up period."

Participating in a Trial: Questions to Ask Your Doctor - National Cancer Institute

A Guide to Understanding Informed Consent - National Cancer Institute

Sample Informed Consent Document - University of Pittsburgh

Where are Clinical Trials Conducted?

Clinical trials are conducted at a wide variety of locations, according to the National Cancer Institute:

"If you were to participate in a clinical trial, you might do so at a large cancer center, a university hospital, or your local medical center or physician's office.

The trial may include participants at one or two highly specialized centers or it may involve hundreds of locations at the same time. You would participate in the trial under the guidance of a team including your physician and other health professionals, who would report your experience during the trial back to the center responsible for the trial's overall coordination. Experts then use the information from all of the participants to evaluate the intervention that the trial is testing."

Carcinoid Clinical Trials

Search CenterWatch

"This is a listing of industry-sponsored clinical trials that are actively recruiting patients. You can use this listing to search for clinical trials by therapeutic area and geographic region."

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Search ClinicalTrials.gov

"ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions."

Search ClinicalTrials.gov

Search National Cancer Institute

"PDQ (Physician Data Query is NCI's comprehensive cancer database) includes the world's most comprehensive cancer clinical trials registry. The registry contains more than 4,000 abstracts of clinical trial protocols that are open/active and approved for patient accrual (accepting patients), including trials for cancer treatment, genetics, diagnosis, supportive care, screening, and prevention. In addition, the registry contains more than 15,000 abstracts of clinical trial protocols that have been completed or are closed to patient accrual."

Search National Cancer Institute