Frequently asked questions.

What types of Clinical Trials are there?

There are many different types of clinical trials, including:

  • Prevention trials that look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

  • Clinical trials that test new treatments, new combinations of drugs, or new approaches for therapy.

  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening trials test the best way to detect certain diseases or health conditions.

  • Quality of Life trials (or Supportive Care trials) explore and measure ways to improve comfort and the quality of life for individuals with a chronic illness.

Usually, clinical trials compare a new product or therapy to something else to see if it works as well or better to treat or prevent a disease or condition. In a blinded study, a participant may be randomly assigned to receive the test product, or an existing, approved therapy.

In some clinical trials, participants may be assigned to receive a placebo (a product with no therapeutic action that looks or acts like the test product). Comparison with a placebo can be the fastest and surest way to demonstrate therapeutic effectiveness of new products.

Potential participants are told before they enter a trial whether placebos are going to be used in the study and the risks and benefits of the study medication(s).

Will my personal information be kept confidential?

The clinical research team will keep your Personal Health Information (PHI) extremely confidential. Your information will not be shared without your permission, except when required by law.

If you choose to submit your information to use through this website, with your permission, this information will be entered into our clinical research database for both current and future study opportunities. You can ask to have your information removed at any time. If you choose to call in and speak to one of our research specialists over the phone, your information will be captured in the same electronic database. Again, this is voluntary and can be removed at any time.

What is a Clinical Trial protocol?

A clinical research study is conducted according to a research plan known as a study protocol which is designed to answer specific research questions and to assure the safety of the participants. The protocol includes the following information:

  • The reason for conducting the study

  • Who may participate in the study (inclusion/exclusion criteria)

  • The number participants needed

  • The schedule of tests, procedures, investigational product and their dosages

  • The length of the study

  • What information will be collected about the participants.

What is informed consent?

To help you decide if you want to be in a study, the MHRA requires that study participants are given complete information about the study before they agree to take part.

Informed consent forms should be written so the participant can easily understand it and should include:

  • purpose of the research

  • how long the study will take

  • what will happen in the study and which parts of the study are experimental

  • possible risks or discomforts

  • possible benefits

  • other procedures or treatments that the participant might want to consider instead of the treatment being studied

  • that MHRA may look at study records, but the records will be kept secret

  • whether any medical treatments are available if the participant is hurt, what those treatments are, where they can be found, and who will pay for the treatment

  • the person to contact with questions about the study, participant rights, or if the participant can get hurt

  • the participant can quit at any time

If you don’t understand the information included in the informed consent form, be sure to ask the doctor or other research staff member to explain it. This discussion should take place in private, and you must be given enough time to make an informed decision. In most studies, you should be allowed to take the consent form home for further discussion with others, such as family, caregivers and primary care physicians. Make sure you understand all of it before you agree to be in the study.

Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason. You may ask questions at any time throughout the study.

In addition, you must also be informed of any new information learned during the study that may affect your willingness to continue to participate in the study.

What questions should I ask?

Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:

  • What is the study trying to find out?

  • What kinds of test and exams will I have to take while I’m in the study? How much time do these take? What is involved in each test?

  • How often does the study require me to go to the doctor or clinic?

  • Will I be hospitalized? If so, how often and for how long?

  • What are the costs to me? Will my health insurance pay for it?

  • What follow-up will there be?

  • What will happen at the end of the study?

  • What are my other treatment choices? How do they compare with the treatment being studied?

  • What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?

  • How long will the study last?

Will it cost me anything and will I get paid?

In most clinical research studies all visits, tests, and procedures related to the study are free of charge. If you qualify for one of our research studies, you may be compensated for your time and travel.

The amount of compensation (as well as any expenses not covered by the study) will be reviewed during the enrolling and informed consent process.

Who conducts a clinical trial?

Every clinical trial is led by a Principal Investigator who is often a licensed medical doctor, and a clinical research team that may include doctors, nurses, social workers, and other health care professionals. In general, the clinical research team roles and responsibilities will include:

  • Principal Investigator (PI): A person responsible for the ethical conduct of the research study. This includes protecting human subjects’ rights, safety and welfare, protocol (study) compliance, and adherence to institutional, state and federal regulations and guidance. The PI is responsible for ensuring informed consent is appropriately obtained from each participant and for appropriately maintaining study records. The PI is also responsible for complying with the financial and administrative policies and regulations associated with the award, overall fiscal management of the project, and conflict of interest disclosure. The PI oversees all aspects of a clinical trial from protocol design, recruitment, data collection, analysis and interpretation of results, but some tasks can be delegated to other research team members (Co-Investigators and Key Personnel). The PI is responsible for ensuring that all research team members have appropriate education, training and qualifications to assume delegated study tests. All study team members are responsible for ensuring that the conduct of the study is compliant with institutional, state, federal and industry guidance and regulations.

  • Sub-Investigator: The Sub-Investigator may perform all or some of the PI functions, but they do not accept primary responsibility for the research study. The sub-investigator is under the supervision of the PI and is responsible for performing study–related procedures and /or to make important study-related decisions in compliance with the ethical conduct of the study.

What happens during a clinical trial?

The following process generally occurs during the conduct of a clinical trial:

Pre-Screening

The clinical research group will review their existing patient databases or medical charts to identify potential patients who may be eligible to participate in the clinical research study. They may also place advertisements on the internet, newspaper, radio, or television to recruit interested participants. They may also conduct seminars, free health screenings, or forums.

Potential participants from these pre-screening efforts are contacted and briefly interviewed to confirm if they are potentially eligible to participate in the clinical research study.

Informed Consent

If you are potentially eligible to participate in a clinical research study, an appointment will be scheduled for you to come to the clinical research site and meet with one of the research staff members. Before any study related procedures are performed you will be required to sign an informed consent form which details the study design, risks and benefits, your rights as a study participant and who to contact in case of an emergency. During the informed consent process, you will have an opportunity to ask questions you may have regarding the study and your participation. You should receive a copy of the signed informed consent form for your records and future reference.

Screening Visit

Once you agree to participate in the clinical research study and have signed the informed consent form, the study screening procedures will be administered. The purpose of the screening visit is to determine if you meet the specific inclusion and exclusion criteria for the specific clinical research study you agreed to participate in. Generally, during the screening visit you may be asked to answer questions regarding your medical history, medications and other treatments you are taking, and complete questionnaires. A member of the research team may also assess your general health by performing a physical examination, EKG and collect blood/urine samples.

Generally, the investigational product is not dispensed during the screening visit.

Study Visits (Treatment Visits)

If you meet the specific inclusion and exclusion criteria (which includes a study acceptable laboratory and medical results) for the study you will be asked to return to the clinic for a series of study visits sometimes referred to as Treatment Visits. It is generally during these study visits that a study participant will be receive the investigational product or the comparator product (which sometimes can be a placebo). The number of study visits and the interval in which the visits occur varies from study to study.

End of Study Visit

Once you have reached the end of the treatment visit, an End of Study Visit is conducted. Generally, the same or similar assessments conducted prior to you receiving the investigational product is repeated. The research team will also discuss you follow-up treatment options (which may include receive standard of care treatments for your illness) and if required by the study you may be asked to return to the research site for a follow-up safety visit.

Follow-up Safety Visit

The number of follow-up safety visits and the interval in which the visits occur varies from study to study. The purpose of this visit is to assure you are not experiencing any lingering side-effects from the investigational product or from the overall participation in the study.