Clinical Research Safety: Ensuring Participant Protections

Clinical Research Safety: Ensuring Participant Protections

Clinical research plays an essential role in identifying and developing new drugs and therapeutics. Yet safety is such a major concern that most Americans say they wouldn’t feel comfortable enrolling.

Consider that a recent survey conducted by researchers at Memorial Sloan Kettering Cancer Center (MSK) found that:

  • Only 35% of Americans were ‘likely’ to enroll in a clinical trial 
  • Only 40% of Americans have a positive overall impression of clinical trials
  • Just 4% of cancer patients enroll in clinical trials nationally each year

For members of the general public, these results might not seem very surprising. But for bioscience professionals, these numbers should act as a wake-up call. 

Without a vested public interest in clinical research, it’s much harder to recruit and enroll patients. And, without a steady stream of new trials coming down the pipeline, it’s much more difficult to identify and develop successful treatments for cancer and various other health issues.

Since clinical trial safety is such a concern for many patients, we wanted to take a closer look at some of the security precautions currently in place. Hopefully after reading this article, you’ll have a better idea of how trials are designed and carried out with patient safety at the top of mind.

Safeguards for Patient Health – Official Guardrails for a Positive Research Experience

Americans have a complicated relationship with science, and the COVID-19 pandemic made things even more strained. 

One survey, conducted by Pew Research, found that just 13% of Americans have a “great deal of confidence” in scientists, while 36% said they have “not too much” or “no confidence at all”. 

Unfortunately, these attitudes don’t just show up in Youtube comment sections and other online forums. They have real-world consequences, leaving people hesitant and often afraid to participate in research they perceive as being risky. 

Though there’s plenty of misinformation out there, patient safety in clinical research is highly regulated and there are several safeguards designed to protect patients throughout each trial phase, including:

Institutional Review Boards (IRB)

An IRB is a panel of experts, including doctors, scientists, and members of the public who work together to ensure no trial participant is at risk. 

IRB representatives are responsible for reviewing and monitoring all test results to ensure the potential for harm is outweighed by the studies’ potential benefits. If the IRB determines that patient safety is at risk they can require modifications or disapprove the research altogether.

Informed Consent

Informed consent provides comprehensive information about a trial as part of the pre-enrollment process. It includes key facts about the study, potential safety concerns, and information about what to expect, including how long the trial will last, the required procedures and emergency contacts. 

During the informed consent process, patients are encouraged to ask questions, request additional information and discuss concerns.

Data and Safety Monitoring Board (DSMB)

The DSMB is a group of decision-makers tasked with monitoring the results of the clinical trial as it progresses. If an experimental treatment doesn’t provide the expected results or there are safety concerns, the DSMB can put the trial on hold or stop it from advancing.

Observational Study Monitoring Board (OSMB)

The OSMB is a group of decision-makers who are responsible for monitoring observational studies –– clinical trials that feature large or potentially vulnerable populations. Like DSMBs, OSMBs monitor trial data and make adjustments if patient safety is determined to be at risk. 

Clinical Research Safety – It’s Your Health and Your Choice

As you can see, there are several guard rails in place to ensure patient safety during clinical trials. Still, the decision to enroll and participate is entirely up to the individual.

The best way to make an informed decision is to do your homework. Before signing off on any paperwork, ask yourself the following questions:

  • Am I making this decision on my own? Or am I doing it because I feel forced or pressured by someone else (like a family member or medical professional)?
  • Does enrolling offer me access to an experimental treatment I might not have access to otherwise?
  • How will I feel if the experimental drug or therapy doesn’t work as expected?
  • Do I feel a sense of duty to others who are living with the same condition or disease?
  • Do I have the time, energy, and resources to participate in the trial from beginning to end?
  • Do I trust the institution, doctors, and nurses who will be running the trial?

After answering these inquiries, weigh the pros and cons. Don’t hesitate to ask friends and family members for their opinions as well.

If you decide that the benefits outweigh any risks and you’re interested in participating, proceed with the informed consent forms.  Keep in mind that informed consent is not a binding contract-If you have second thoughts in the future, you can back out of the trial for any reason.

Start Researching Clinical Trials 

Signing up for a clinical trial is a big decision, but when it comes to safety, there’s little to worry about. Biopharmas, sponsors, and other decision-makers take their responsibility to patients seriously and have implemented several features to prevent negative outcomes. 

If you’re interested in enrolling in a clinical trial, check out the database. It features a list of privately and publicly funded studies currently being carried out in various parts of the world.

To access more industry news and clinical trials-related content, check out the Harbor Clinical blog. 

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