FAQ

People considering participating in a research study often have many questions. Here are some of the most frequently asked questions.

What is a Clinical Trial?

A clinical trial is a study conducted with volunteer participants, usually to evaluate the safety and effectiveness of a new drug or new medical device or treatment. Each study is designed to answer scientific questions, and to find new and better ways to help patients. The doctors who conduct clinical trials follow a carefully designed treatment plan called a “protocol.” A protocol specifies the medications, dosages, and length of treatment, and details such matters as frequency of visits, and which tests will be required to monitor progress. Of course, in addition to providing answers to research questions, all Dean Foundation studies are designed to safeguard the medical and psychological health of patients. Medications used in treatment are strictly monitored by the Food and Drug Administration (FDA), the government agency that approves all medications used in the United States.

Why should I participate in a Clinical Research Trial?

By becoming involved as a volunteer clinical research participant, you will have the opportunity to benefit from unique, state-of-the-art methods of care. And in the process, you will be helping to enhance the quality of life for future patients, too.

Who benefits from a Clinical Trial?

All Dean Foundation clinical trials are comprised of volunteer participants. People choose to participate for many different reasons. As you might imagine, many people take part to improve their personal health. They may hope for a cure to a disease to live longer or feel better. On the other hand, many also wish to contribute to a research effort which may help others in the future.

Volunteer participants in clinical trials are among the first to receive new research treatments or drugs before they are widely available. Thus, they have the first opportunity to benefit from them.

The volunteer participants in our studies receive the benefit of the combined expertise of our physicians. Participants become part of an invaluable network of researchers combined with physicians who pool their ideas and knowledge from many disciplines. All participants are carefully monitored during and after a trial.

Will I be paid to participate?

Some drug studies offer compensation to volunteer participants. Oftentimes, studies provide access to free medical and laboratory evaluations or costly medications. And if a study involves a number of clinic visits or involved procedures, patients are likely to receive financial compensation for their time and effort.

Are there risks or side effects?

With any new drug, there may be risks as well as possible benefits. Because clinical trials involve research into new areas of treatment, the risks cannot always be known ahead of time. The Dean Foundation makes every effort to determine what those risks might be.

The drugs and treatments used can sometimes cause side effects, depending on the type of drug and the patient’s own condition. Side effects vary from participant to participant, just as they do with standard treatments and standard prescribed medications.

What is Informed Consent?

Informed consent means that, as a volunteer participant, you are provided with complete information about what is to be involved in the trial. This information includes such issues as the purpose of the trial, potential benefits and risks, number and type of visits or procedures required, those responsible for the study, and how to get more information. Informed consent is required in all studies that are conducted within the Foundation. The nature of the treatment is fully explained by the doctors and nurses in the trial. You are given an informed consent form to read and consider carefully. You are encouraged to ask questions so you can decide freely to take part in the trial or not. If you agree, you can sign the form. Of course, you may also decline participation.

Is everything confidential?

During the study, complete confidentiality of your records will be maintained. You will be identified by a number or initials – never by your name.

Are there strict guidelines?

There are a few basic guidelines that help ensure successful research. They include:

  • Follow labeled directions on investigational drugs exactly.
  • Notify personnel of any adverse reactions.
  • Inform research team of all current medications.
  • Return all unused investigational medications.
  • Keep accurate records in the diary cards.
  • Get instructions from the team if you miss a dose/treatment.

What happens if I want to participate?

If you are interested in becoming part of a clinical trial, you will first need to be screened for eligibility. Next, you will be asked to sign the consent form, which provides details about the research. You will also be assigned a contact person.

Can I withdraw from a study?

Participation in research is voluntary and can be discontinued at any time. A follow up visit is necessary upon termination to assess your health status. All unused drugs must be returned. You can then resume your regular care routine.