PARTICIPANT INFORMATION

Below you’ll find information and answers to questions that will help give you a better understanding of clinical trials and the benefits of participating. If you have any questions about participation or qualifying for trials you can contact the BTC team at info@btcsites.com.

CLINICAL TRIAL FAQS

Clinical trials are the last stretch of the long road of research and development that new drugs go though. In this final step, people volunteer for research studies that will test the safety and effectiveness of new medicines. Investigational drugs are given to clinical trial participants only after the drugs have gone through a rigorous testing process and the evidence indicates that the drug is likely to be safe and effective in people. Through clinical trials, we find innovative ways to improve the prevention and treatment of diseases.

Every medicine and treatment available today once went through a clinical trial. Whether it’s a lifesaving cancer drug, or a popular pain reliever, volunteers tested it in a clinical trial at one point! Through clinical trials, researchers determine if new treatments are safe, effective, and work better than existing medicines. Clinical trials can also uncover better ways to prevent and detect diseases. Modern medicine has helped millions upon millions of people but there are still lots of diseases without cures and effective treatments. Without clinical trial participants, there would be no forward medical progress.

Besides contributing to medical research, clinical trials give you an opportunity to gain access to new medical treatments that aren’t yet available to the public. Clinical trial participants also receive expert medical care and play more active roles in their own health. Studies often offer reimbursement for your time and medical care at no cost.

Patient safety is a top priority for everyone on the clinical trial research team. While many safeguards are put in place to protect clinical trial participants, clinical trials are testing investigational medicine. As with any medical treatment there may be some risk of side effects and there is no guarantee that treatment will be effective.

  • What is the purpose of this trial?
  • Can I continue taking my regular medications when I volunteer for a study?
  • What happens if I decide to withdraw from the study?
  • How can I involve my regular doctor in the clinical trial process?

Clinical research studies are most often sponsored by drug and biotech companies.  Typically they will work together with medical centers, academic institutions, or doctors’ offices to conduct research on their investigational medications.

An ethics committee must review clinical research studies before they begin. In addition the FDA (Food and Drug Administration), a department of the US government, sets requirements for drug testing. They also review the results from certain clinical research studies to decide if an investigational drug should be made available to the general public. An ethics group that reviews a clinical research study is called an IRB (Institutional Review Board). The IRB is a group of doctors, nurses, and people from the community. The IRB’s job is to review all clinical research studies to help protect participants’ rights and safety.

A research team led by a doctor, known as the Principal Investigator, conducts the research study. The team may include nurses, coordinators and others. This team may conduct the clinical research study in a hospital, university, local medical center, or doctors’ office.

Each clinical research study has different requirements for participants such as age, sex or medical condition. It is important that different kinds of people are involved in each trial since everyone does not respond to medicines and treatments the same way.

Informed consent is the process that takes place before you join the study. A doctor, nurse or study coordinator on the team will explain why the study is being done, and what you can expect. You can ask any questions about the study at this time.

You will be told about who will see your personal medical information and how it will be kept confidential. You will also be given a consent form to read. You should ask questions about any part of the consent form you do not understand. If you decide to take part in the study, you will be asked to sign the consent form. Even after the consent form has been signed, you are able to drop out of a clinical trial at any time.

During the study, the study team will review your medical history, give you instructions on participating, and monitor your health. Some clinical research studies may involve more tests and doctor visits than you would normally have for an illness or condition.

If you are interested, you can talk to your doctor or healthcare provider to see if a clinical research study is right for you. To learn more about being in a clinical research study, please call 857-284-7574.

CLINICAL TRIAL MYTHS

Do you know which Clinical Trial myths are true or false? Test your knowledge by hovering over the answers below.

PATIENTS ON CLINICAL TRIALS ARE TREATED LIKE GUINEA PIGS.

  • TRUE

    This is False.

    Patients often report they are treated with respect and the highest degree of care during their clinical trial experience. Many safeguards are put into place to protect patients involved in trials. They typically receive more frequent and careful medical attention.

  • FALSE

    This is False.
    Patients often report they are treated with respect and the highest degree of care during their clinical trial experience. Many safeguards are put into place to protect patients involved in trials. They typically receive more frequent and careful medical attention.

PATIENTS WHO PARTICIPATE IN CLINICAL TRIALS RECEIVE BETTER QUALITY CARE THAN THOSE WHO DON’T

  • TRUE

    This is True.

    Research shows that people involved in clinical studies do somewhat better than people in a similar stage of their disease who are not enrolled, regardless of whether the experimental treatment works. This may be due to the general high quality of care provided during clinical studies. Many safeguards are put in place to protect patients in clinical trials. They typically receive more frequent and careful medical attention.

  • FALSE

    Actually, this is True.
    Research shows that people involved in clinical studies do somewhat better than people in a similar stage of their disease who are not enrolled, regardless of whether the experimental treatment works. This may be due to the general high quality of care provided during clinical studies. Many safeguards are put in place to protect patients in clinical trials. They typically receive more frequent and careful medical attention.

HEALTHY PATIENTS CAN PARTICIPATE IN CLINICAL TRIALS

  • TRUE

    This is True! 

    There are lots of important clinical trials that require healthy volunteers. Healthy volunteers provide researchers with important information for comparison with people who have specific illnesses.

  • FALSE

    Actually, this is True! 

    There are lots of important clinical trials that require healthy volunteers. Healthy volunteers provide researchers with important information for comparison with people who have specific illnesses.

CLINICAL TRIALS ARE ONLY FOR THOSE WHO HAVE NO OTHER OPTIONS

  • TRUE

    Actually, this is False. 

    No matter where you are in your treatment process, there may be a clinical trial that is right for you. A clinical trial may be a patient’s best available treatment option. Be sure to discuss all options for treatment with your physician, and ask if there are clinical trials available to you.

  • FALSE

    You’re right! This is False.

    No matter where you are in your treatment process, there may be a clinical trial that is right for you. A clinical trial may be a patient’s best available treatment option. Be sure to discuss all options for treatment with your physician, and ask if there are clinical trials available to you.

ONCE I START A TRIAL, I’M STUCK AND CANNOT BACK OUT

  • TRUE

    Actually, this is False. 

    A participant may decline to participate at any point of the trial. Involvement in a clinical trial is entirely voluntary. If you were to begin a clinical trial you can stop at any time for any reason and return to the standard treatment.

  • FALSE

    You’re right! This is False.

    A participant may decline to participate at any point of the trial. Involvement in a clinical trial is entirely voluntary. If you were to begin a clinical trial you can stop at any time for any reason and return to the standard treatment.

Learn more about clinical trial participation in this video:

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