Questions to Ask Before Participating in Clinical Research

Participants want answers and solutions when they have a health problem. Sometimes participating in a clinical trial can allow a person to play an active role in their own healthcare, gain access to a new treatment before it becomes widely available, and help others by contributing to medical research.

With that said, it's important to be informed about a clinical trial — its purpose, duration, necessary procedures, who may or may not be qualified to participate, key contacts, and potential risks and benefits. Agreeing to participate in a study and signing the informed consent document is not a contract. The participant may withdraw from the trial at any time.

If you're considering participating in a clinical trial, ask your doctor some basic questions before participating. This blog provides a list of essential questions about clinical research and the answers you should expect from your doctor.

Question: What is the purpose of the clinical trial?

Volunteers should clearly understand the differences between the study drug(s) and other available treatment options. They should ask why study investigators think an experimental therapy could be better than standard-of-care treatment approved by the Food and Drug Administration and why the new drug might not perform as hoped.

In addition, volunteers should understand the overall objective of a study, including the clinical trial’s phase and what that means. For phase 1 clinical trials, volunteers must understand that the goal is to look for a safe dose in humans. It’s fine to hope the treatment might help, especially if it’s a personalized, or targeted, therapy, but if volunteers want something with higher effectiveness and a more known side-effect profile, then phase 1 clinical trials may not be for them.

In phase 2 or 3 trials, treatments are tested for effectiveness, sometimes with certain volunteers getting the experimental treatment and others receiving a different therapy for comparison. In some cases, the trial design keeps patients from knowing whether they’re getting the experimental drug, another aspect they should ask about in advance.

If they are going to be randomized to receive standard treatments, or standard of care plus the experimental treatment, or even placebo, they’ll need to understand this before anything else. They need to make sure they’re informed about the goal of the study and that they don’t have any false pretenses about what the study is going to do for them.

Question: How long will I be in the clinical trial?

The length of a clinical trial or research study is different depending on the study. When volunteering for a trial, you will be told the duration before you decide to participate.

Question: What kinds of tests and treatments are involved?

Treatment Trials

Test new treatments, combination drugs, or procedures.

Prevention Trials

Looks for better methods to prevent disease in people who have never had the disease or to prevent the disease from returning in people who were already diagnosed.

Diagnostic Trials

Finds better tests or procedures for diagnosing a disease or other medical conditions.

Screening Trials

Tests the best way to detect the presence of a disease or health condition.

Quality of Life Trials

Explores methods to improve comfort and quality of life for individuals with chronic illnesses.

Question: How will I be told about the clinical trial's results?

Ask your researcher about the progress of the results. Some trials are completed in weeks or months, and these results are available quite quickly. Other trials are carried out over several years, and it may be a long time before the final results are known, but you may be able to find out how the trial is progressing.

Question: Who can I speak with about questions I have during and after the clinical trial?

Anyone interested in participating in a clinical study should know enough about the study and feel comfortable asking the research team questions about the study, the required procedures, and any costs. Answers to some of these questions are provided in the informed consent form. Many of the questions are specific to clinical research trials, but some also apply to observational studies.

Question: Who will be in charge of my care?

Every clinical trial is led by a principal investigator, who is often a medical doctor. Clinical research studies also have a research team that may include doctors, nurses, social workers, medical institutions, and other health care professionals.

Question: What are the new treatment's possible side effects or risks?

Risks to taking part in clinical trials include the following:

• The experimental treatment may have unpleasant, serious, or even life-threatening effects.
• The study may need more time and attention compared to the standard treatment, including multiple visits to the study site, more procedures, hospital stays, or complex dosage schedules.

Question: What are the possible benefits?

There are possible risks and benefits associated with many clinical trials. The benefits include:

• helping contribute to knowledge about new treatments or procedures
• gaining access to new research treatments before they become widely available
• receiving regular and careful medical care from a research team that includes doctors and other healthcare providers

Question: How will my health information be kept private?

Several protections are in place to ensure clinical trials are safe for participants. The informed consent form is one of the most important components of a trial that protects patients. When participants decide to join a clinical trial, they sign this form, which outlines all relevant details and privacy aspects of the trial. Also, an Institutional Review Board (IRB) assesses every trial's protocol to ensure it's ethical and that patient rights are protected. Also, the FDA provides oversight for clinical trials testing new medicines or medical devices. Before clinical trials start, the FDA reviews applications for new medications and makes sure studies have protections in place for participants.

Question: What happens if I decide to leave the trial?

Ask about what's happening to your care if you decide to leave the study before it ends and what side effects you might incur from potentially coming off an investigational drug.

Question: Who pays if I'm injured in the trial?

It’s important to ask about your personal health and safety before joining a trial.

Question: How could the trial affect my daily life?

There’s another way that clinical trials could have a significant impact on your life. By participating in a clinical trial, you could help us in our pursuit of life-enhancing discoveries. Also, you may qualify for a free comprehensive medical screening. You may be compensated for your time if chosen to continue the trial.

Question: How often will I have to come to the hospital or clinic?

Your doctor will inform you about your time commitments if you decide to take part in a trial. This will vary from trial to trial and will often involve more visits than usual to the hospital. You should be told how often you will need to visit the hospital and how long the visits will be. Extra visits may cost you time and money; ask if there is money available to cover your fares.

Your doctor or researcher should be able to provide a plan for you, but, as with all treatments, this may need to be adjusted as situations change. The plan should tell you what tests to expect. These may include blood tests, X-rays, and interviews.

If the clinical trial is not at a hospital near you, ask if you can attend your local hospital for any trial treatments. For example, you may be able to have a blood test locally.

Question: Will I be compensated for participating in the clinical study?

Clinical trial volunteers are often compensated for their participation. The amount of compensation will vary and is usually determined by the clinical trial's time commitment and any physical discomfort that may result from the study.

Question: Will I have check-ups after the trial?

Ask any questions about what happens after the study is over before signing up, especially if the intervention ends up helping you!

Contact Santos Research Center, Corp.

Participating in clinical trials helps in discovering the medicines of the future.

If you are interested in Paid Medical Trials at Santos Research Center, Corp., please contact us at (813) 249-9100 or visit us at 5927 Webb Rd Tampa FL 33615.