Pros and Cons of Clinical Trials

Pros and Cons of Clinical Trials

Each clinical trial has its benefits based on the type of trial and what it is trying to do. However, certain possible advantages and complications are common to most clinical trials. In this article, we are going to learn about the pros and cons of clinical trials. Also, we will talk about the cons of clinical trials.

Key Facts about the Pros and Cons of Clinical Trials:

  • Clinical trials as the term refer to real patients’ medical care
  • They are a medical study method that follows a defined protocol that has been specifically created to answer a specific patient care question
  • Clinical trials are in place to assess cancer therapies, cardiovascular disease treatments, the safety and effectiveness of new drugs, and various other conditions. These are some of the pros of clinical trials.
  • Clinical trials may investigate the efficacy of new drug treatments, new drug formulations, surgical procedures, or behavioral and lifestyle changes
  • Clinical trials are broken down into stages, each stage having a different purpose in the study
  • Institutional Review Board (IRB) consisting of doctors, statisticians, researchers, and patients
  • Advocates and others would pre-approve every drug trial in the U.S. This means that the trial is legal and protects patients’ rights. And that it is sufficient to answer the question from a scientific and statistical point of view
  • Each clinical trial has a protocol that describes the groups of individuals who may participate in the trial. It details the exact schedule of tests, treatments, drugs, and doses used in the trial; and specifies the study’s duration
  • Each trial has specific participation and exclusion criteria to determine the exact patient population that may participate. Criteria for inclusion can depend on age, gender, underlying illness, health status, or other factors

What are clinical trials?

Clinical trials are a clinical research method that follows a defined protocol. The protocol specifically exists to evaluate a medical question. 

A clinical trial is a prospective biological or behavioral analysis of human subjects to a certain substance. It is designed to answer particular questions about biomedical or behavioral therapies. These include medications, treatments, devices, or new methods of using known drugs.

People commonly associate clinical trials with drug trials in which new medications or combinations of drugs are tested for their efficacy against illness. But, clinical trials may also determine whether treatments such as counseling or lifestyle modifications impact disease development.

Clinical studies are performed on patients who have a disease or on healthy people. It depends on the research’s purpose.

The U.S. NIH describes the following types of clinical studies:

  • Treatment trials are testing new treatments, new formulations of drugs, or new forms of surgery
  • Prevention studies identify ways to prevent illness through medications, lifestyle improvements, nutritional supplements, such as vitamins, or immunizations
  • The purpose of diagnostic studies is to identify improvements in the procedures or techniques used to diagnose the disease
  • Screening tests look at ways to diagnose specific diseases before the patient shows the illness’s signs
  • Quality of life trials intend to improve comfort and quality of life for individuals suffering from chronic illnesses or diseases

The Pros and Cons in Clinical Trial

1. The Pros of Clinical Trials

Access to treatment is not yet available. This treatment could be more successful or have fewer side effects than currently available treatments. This is one of the major pros of clinical trials.

Daily and careful treatment from some of the best cancer clinicians. The research team that performs clinical trials usually includes top doctors and scientists. They are from all over the United States and the globe, all of whom will be working with you. Because of this rigorous monitoring, any side effects might have been detected and treated immediately.

Treatment that could be free or low cost. This is one of the major pros of clinical trials. Some clinical trials may cover part or all of the medication, other medical care, travel, etc. But not all clinical trials do so. Learn what you’re going to have to pay for before you agree to be part of a clinical trial. 

Lead to research that will save lives in the future. Breast cancer drugs that we have today—include Herceptin, tamoxifen, aromatase inhibitors, and more. They are available because many women have agreed to take part in clinical trials to test them.

Feeling that you have an active role to play in your treatment. Deciding to participate in a clinical trial may help some people feel more control over their situation. This can lead to a more positive outlook and an improved quality of life.

2. The Cons of Clinical Trials 

Not being able to select a treatment for yourself. This is one of the major cons of clinical trials. In randomized trials, you are randomized to receive a specific treatment. You may be assigned to placebo in some trials (sugar pill). In a randomized, double-blind experiment, neither you nor your physicians know the treatment you are receiving (but if the information is needed, it is available).

New treatment may not succeed for you, even though it benefits other patients during the study. It can also turn out that the new treatment is not as successful as what is currently available. This is one of the major cons of clinical trials. 

More extreme side effects than current treatments. This is most likely to happen in Phase I or Phase II trials.

The insurance company may not bear any of the costs. Be sure to talk to both the health provider and one of the clinical trial coordinators to know exactly what you’re going to have to pay for BEFORE you agree to be part of a clinical trial.

More frequent tests and visits to the doctor. Because you’re going to be closely monitored, you may have to undergo tests more frequently. This could mean more travel and time for you in the doctor’s office or hospital.

Benefits of science and future health care:

  • Lead to the development of new medicines and guidelines for treatment
  • Lead to the discovery of ways to prevent or treat illnesses or disorders of health
  • Improve the training of doctors, nurses, and other health professionals
  • Impact of health policy and support for health services

Should you agree to take part in a clinical trial?  

This may be a very difficult question. The answer is not going to be the same for everyone. When you try to make a decision, ask yourself a few questions first.

  • Why do I want to participate in a clinical trial?
  • What are my goals, and what do I expect if I decide to participate? How realistic are they?
  • How sure are my physicians about my future if I decide to participate (or not participate) in this clinical trial?
  • Do I have all the information that I need to make an informed decision?
  • Have I measured up the benefits against the risks?
  • Am I thinking about other factors, such as travel, time, and money?
  • Have I been looking at my other options?

Some of these questions may not have clear answers. But they can help you start thinking about these topics. Every participant’s situation is unique. And the reasons for wanting or not wanting to take part in a trial might be different.

The Bottom Line: Pros or Cons of Clinical Trials

Regardless of whether you are prescribed a placebo or a new medication, you will be carefully monitored during the trial. Suppose the situation gets worse at any moment. In that case, the researchers will consult with you and your care team to decide the next steps. Please remember that the trial does not take priority over your health.

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