When people hear the words ‘clinical trial,’ it’s usually accompanied with raised eyebrows and feelings of apprehension. Clinical trials are at the heart of medical advancements, but many people are weary of participating. What causes these feelings of apprehension and doubt? If you’re someone that’s looking into clinical trials, your first fear may be the safety of the trials. Can anyone participate? What are the criteria? What happens during the clinical trials?
Who can be involved?
Clinical trials are federally regulated and have built-in safeguards to protect participants. Before a participant is eligible to participate, they must pass strict criteria called inclusion and exclusion criteria. Participants must give also give informed consent. This means that they understand the key facts of the trial, and have decided to continue with the treatment. Once the individual has passed the inclusion criteria and given their informed consent to participate, confidentiality is paramount to the trial. The names of participants are kept private and are not recorded in the medical reports.
Are clinical trials safe?
There are risks involved with clinical trials, but there are also many benefits (see misconception #2). Not all clinical trials are created equally. Most clinical trials must follow carefully controlled protocols with a detailed study plan. These plans outline the role of the researcher. Researchers must also report their results to scientific meetings, medical journals, and government agencies as the trial progresses.
The common misconceptions that deter participation
Many proponents of clinical trials will champion the cause by saying that clinical trials advance medical knowledge and propel scientific advancements, but these general statements may not be of concern to you. Although, it is true that clinical trials play significant roles in bringing treatments from theory into practice, it is also true that patients should be aware of the risks. Before making the decision to participate, talk to your doctor to determine if clinical trials are the best thing for you.
- Clinical trials are unethicaland purely for scientific advancement—False
- There are strict guidelines that determine if a treatment will actually make it into a clinical trial. These are the five phases of the clinical trials:
- Phase 1: Researchers test the drug or treatment on a small group of ‘healthy’ volunteers (20-80) to determine its safety, the correct dosage, and any side effects that may arise.
- Phase 2: The drug or treatment is given to a larger group of people with the target illness (100-300). Its safety and effectiveness are further determined.
- Phase 3: The drug or treatment is given to an even larger group with the target illness (1,000-3,000). Its effectiveness and safety continue to be monitored, along with the potential side effects. Information is collected throughout this process.
- Phase 4: The treatment is compared to other treatments for the same illness. Participant safety continues to be monitored.
- Clinical trials are unsafe—False
- There are risks involved when participating in clinical trials:
- Potentially unpleasant, serious, or life-threatening side effects
- Treatment may not be effective
- Treatments may involve a lot of the participant’s time and attention. Some examples include trips to the study site, more treatments, hospital stays, or complex dosage requirements.
- However, there are also advantages:
- Gaining access to new treatments before they’re available to the general public
- Playing an active role in your health management and treatment
- Helping others with the same illness by contributing to medical research
- Proving the effectiveness of the treatment
- Helping to determine its most appropriate use, i.e. when to use the treatment: first treatment or later on depending on the disease’s progression, or used only if other treatments have not worked.
- There are risks involved when participating in clinical trials:
- Being in the control groupmeans no benefits for the participant—False
- Placebo effect: The expectation that you’ll get better has a beneficial effect. Participants who are in the control group do report feeling better.
- Those in the control group are monitored closely, have regular assessments and check-ups, and are able to talk to health professionals on a regular basis.
- Many people get better due to the nature of their disease.
- Some people in the control group report side effects: Although this group is unaware that they are not taking the treatment, researchers can compare these side effects with those experienced by the treatment group to determine if there are other factors at play in the illness.
- Having a control groupis unnecessary—False
- Having both a control group and a treatment group allows researchers to determine that the benefits or side effects of the trial are due to the treatment, itself.
- Placebo groups don’t get any treatment—False
- Besides being monitored and assessed often, some control groups receive medicine that is already known to treat the illness, while the treatment group gets the clinical trial drug or treatment.
- Researchers will unintentionally affect the results with their biases—False
- Double-blinded trials make sure that both the participants and the researchers do not know what group the participants are in, thereby preventing biases from both parties.
- Properly designed trials are randomized. This means that the participant has an equal likelihood of being in either the control group or the treatment group.
Questions to ask before participating in the clinical trial
Being informed and asking questions is paramount to patient empowerment. Here is a list of questions that you should ask before participating:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
Should I participate in a clinical trial?
This is a question that should be discussed with your physician. It’s also advisable to get second opinions from other doctors or specialists in order to get a more in-depth prognosis for your illness. Should you decide to participate in a clinical trial, make sure your concerns are thoroughly addressed. Being fully informed of the benefits and side effects of the treatment will give you a more active role in your own health management.