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Last Updated: 06/22/15

Clinical Trials Questions and Answers for Prospective Participants

Why should I consider a clinical trial?

A clinical trial may be able to offer an option and hope when standard of care treatments have failed. For more information, please see the National Institutes of Health (NIH) Clinical Trials and You website: http://www.nih.gov/health/clinicaltrials/index.htm

What are the different types of early-phase clinical trials?

Phase 0 studies: Researchers study how the body responds to a drug and how a drug behaves in the body. Phase 0 trials expose the patient to less toxicity and can be performed in less time with fewer patients, allowing researchers to weed out the drugs that aren’t producing the desired effects much more quickly and avoid moving those drugs on to phase I, II, and III trials.

Phase I studies: Researchers test a new drug or combinations of drugs or a new treatment in a small group of people to evaluate the safety, determine a safe dosage range, and identify side effects.

Phase II studies: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety, usually in a specific type of cancer.

Answers from http://www.nlm.nih.gov/services/ctphases.html and http://www.cancer.gov/newscenter/qa/2007/phasezeronextqa

Will a clinical trial help me?

We hope that you will get personal medical benefit from taking part in a clinical trial, but we cannot be certain. Because there is not much information about a given drug’s effect on your cancer, we do not know if you will benefit from taking part in a study, although the knowledge gained from clinical trials may help others in the future who have cancer.

What do I have to do/sign to take part?

Taking part in NIH research is entirely voluntary. Therefore, we ask each patient to sign an informed consent form prior to enrolling on any clinical trial. The informed consent process will take place with a research team member and will describe the research study. Before you decide to take part, please take as much time as you need to ask any questions and discuss the study with anyone at NIH, or with family, friends, or your personal physician or other health professional.

Who can participate in National Cancer Institute Developmental Therapeutics Clinic trials?

Clinical trials in the Developmental Therapeutics Clinic (DTC) at the NIH Clinical Center are open to patients with cancer, regardless of where they live in the United States. Our patients have usually been treated unsuccessfully with standard-of-care therapy for their cancer and are seeking alternative treatment options.

How do I know if I am eligible to participate?

Each potential participant is reviewed for preliminary eligibility for DTC trials prior to scheduling a visit to the DTC. While there are some general inclusion/exclusion criteria that must be met by all participants, our providers review each patient’s records individually to determine whether they are potentially a suitable candidate. The referral coordinators will work with you and your physician to acquire all of the necessary records for this review process. For more information, please see the Referral section.

Who should I talk with about participating?

We encourage you to talk with your friends, family, local physicians, or anyone else who might help you make the best possible decision. Before patients begin cancer treatment, it is important that they talk with their health care professional about all available treatment options, including whether enrolling in a cancer clinical trial may be right for them. Participating in a clinical trial is an important decision, and we welcome the chance to discuss any questions or concerns you might have regarding our studies or individual procedures.

Where can I participate?

Patients are required to travel to the NIH Clinical Center in Bethesda, Maryland, to participate in any of the DTC’s clinical trials. However, the frequency and duration of those visits may differ based on the specific trial and whether some procedures, including labs and physical exams, may be able to be completed at your local oncologist’s office. Please review the protocol consent form for the required visit days at the clinical center.

How much does it cost to participate?

There is no charge for medical care received at the NIH Clinical Center. Patients will be responsible for travel costs for their initial screening visit. In most cases, once patients are enrolled in a trial, the NCI will pay some of the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem payment to help offset the costs of meals and lodging if they are being treated as outpatients. It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.

Do I keep my local oncologist?

We encourage you to keep your relationship with your local oncologist and primary care physician throughout the clinical trial in order to ensure that you have care available for all issues or problems outside the scope of the trial. We will work with them to ensure that pertinent information is shared and to monitor your safety while on the trial.