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What Are the Pros and Cons of Clinical Trials?

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pros and cons of clinical trials
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If you’ve ever taken a medication for a health issue, chances are, it’s because someone like you signed up to participate in a clinical trial. Without rigorous clinical trials and testing, medical research would be extremely limited, as researchers wouldn’t understand the efficacy of specific medications and devices. Participating in a clinical trial isn’t just beneficial for you; it can also support the health of your community. 

Joining a clinical trial, however, is a personal decision you should make with care. Each clinical trial has its own potential benefits and risks. If participating in a clinical trial is something you’ve considered or would be interested in, it’s important to understand both the pros and cons of the experience to help you make an informed decision. 

What Is a Clinical Trial?

When a research team needs to evaluate a new medication or treatment, they use clinical trials to safely test their product on volunteer participants. Some trials require subjects to meet certain criteria, such as having a specific condition. Others may involve otherwise healthy participants or individuals at risk for a certain disease. 

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Clinical trials can test for:

  • Drugs
  • Procedures
  • Treatments
  • Medical devices
  • Preventative care
  • Lifestyle or behavioral changes

Clinical trials are comprised of different phases. If you join a clinical trial, you typically participate in only one phase. Some phases may just take a few months, while others can take years. 

  • Phase 1: In this phase, researchers test a small group of participants, usually fewer than 100. The goal is to test the drug or treatment for safety, best dosages, and potential side effects. 
  • Phase 2: Researchers expand the group to about 100 to 300 individuals and continue testing safety and efficacy.
  • Phase 3: The drug or treatment is now administered to a much larger group of people, around 1,000 to 3,000. In this phase, researchers compare the treatment to others, watch for side effects, and continue to monitor participants. 
  • Phase 4: The drug has now been approved by the FDA and can be sold to the public. This phase can last for decades as researchers continue to monitor the treatment’s efficacy and long-term safety. 

Simran Padam, MD, serves as Executive Director, Medical Affairs – Oncology for Worldwide Clinical Trials. According to Dr. Padam, the multiple phases of clinical trials help researchers to better understand how a treatment can be used in the real world. 

“One thing I always like people to understand is that an earlier-phase trial isn’t necessarily ‘better’ or ‘worse’ than a later-phase trial,” Dr. Padam says. “It simply means we know less about the treatment, so there may be more uncertainty.”

RELATED: 4 Common Myths About Clinical Trials

What Are the Potential Benefits of Joining a Clinical Trial?

Below are the potential benefits of participating in a clinical trial:

Access to Cutting-Edge Treatments or Therapy

Clinical trial participants may be able to try a new medication or treatment for their specific condition. 

“This can be especially important for someone who has already tried the standard treatments available to them,” Dr. Padam says. “I think it’s important to be very clear about something: participating in a clinical trial doesn’t guarantee that the new treatment will work for you. That’s why we are doing the research in the first place.”

Health Monitoring

Along with a new treatment, participants usually receive a dedicated research team that conducts check-ups and closely monitors their health. This monitoring is often more detailed than standard medical care and includes safety and side-effect checks.  

Contributing to Community Health

Krishna Sai Penumarthi, PharmD, PGDipRA, MSRA, CCRP, is a clinical research manager for Advanced Foot Care in Scottsdale, Arizona. Drawing on his clinical trial experience, Dr. Penumarthi emphasizes the importance of clinical trial participation to the community. 

“Almost every treatment we routinely use today exists because patients before us agreed to participate in research,” Dr. Penumarthi says.

Financial Compensation

While this varies by clinical trial, some trials offer the potential for financial compensation and coverage of medical costs. Some trials may also reimburse participants for travel. 

“At the same time, I would never tell a patient that joining a trial means the new treatment will

help them,” Dr. Penumarthi says. “If we already knew with certainty that it worked and understood all of its risks, we wouldn’t need the clinical trial. That uncertainty is part of research. I think patients deserve to hear both sides clearly: there can be hope without making a promise.”

What Are the Potential Risks and Disadvantages?

All clinical trials carry some potential downsides. 

These can include:

Side Effects

A study participant may experience negative side effects from their specific medication or treatment. While a dedicated research team closely monitors a subject, uncomfortable or unwanted side effects are still possible, depending on the treatment. 

No Effective Treatment or Randomized Group

If you participate in a clinical trial, there is a chance the medication or treatment you receive does not affect your condition. Depending on the study, randomization may also place you in a placebo group. 

Time Commitment 

Participating in a clinical trial often requires committing time for weeks, months, or even years.

“A protocol may require repeated visits, blood draws, imaging, procedures, diaries,

questionnaires, transportation, time away from work, childcare, or long follow-up periods,” Dr. Penumarthi says. 

Financial Loss Due to Transport

As noted, some clinical trials may require transportation to and from clinics for testing and check-ups. Unless the specific study offers to cover these costs, this can burden some individuals and their families. 

“I always encourage patients to ask what participation will look like in their everyday life,” Dr. Padam says. “This includes how often they will need to come in, how long the visits will last, whether they will need someone to drive them, whether travel will be necessary, and what will happen if they develop a side effect.”

What Does Clinical Trial Participation Really Involve?

In a typical clinical trial, a participant can expect screening and an eligibility assessment, which includes informed consent if they are deemed eligible for the study. Throughout the trial, a subject will complete study visits, tests, procedures, questionnaires, and symptom tracking. Some trials offer remote visits, while others may require travel. After a treatment, participants will typically receive follow-up appointments with medical providers. 

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Questions to Ask Before Joining a Clinical Trial

It is always encouraged to ask questions to your provider or the research team before joining:

  • Why is this study being done?
  • What treatment options do I have?
  • What is already known about this treatment?
  • Why do you think this trial may be appropriate for me?
  • What are the possible benefits and risks?
  • How often will I need to come to the clinic or hospital?
  • Is transportation available?
  • Who should I contact if I’m having side effects or problems?
  • What happens if the treatment isn’t working for me?

Why Representation in Clinical Trials Matters

In clinical research, trials need participants from different racial and ethnic backgrounds, as treatments can affect individuals and populations differently.

Historically, Black Americans have been underrepresented in many areas of clinical research, from oncology trials to brain research. When members of a marginalized or underrepresented community participate in clinical trials, they can help researchers better understand whether new treatments work across diverse populations.

“Ultimately, we want the evidence behind a treatment to represent the people who will actually be receiving that treatment once it becomes available,” Dr. Padam says. “This is why representation isn’t just about meeting a diversity goal. It’s part of doing better science and providing better care.”

RELATED: The Hidden Costs of Missing Diversity from Clinical Trials

How to Find a Clinical Trial

If you or a loved one are hoping to find a clinical trial, here are a few resources to consider:

Final Thoughts

Since participating in a clinical trial is quite a personal choice, knowing the ins and outs of the process is vital for a potential participant. A patient may experience beneficial treatment, negative side effects, various risks, financial compensation, or transportation costs. In short, a clinical trial isn’t just one appointment, Dr. Penumarthi says.

“It’s an ongoing partnership between the participant and the research team, guided by a carefully designed protocol,” he added.

If you’re unsure of where to start when it comes to searching for an appropriate clinical trial to take part in, you can visit BlackDoctor’s Clinical Trials Resource Center to view open trials.

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