Clinical Trials: Safety is Key

If you are considering volunteering in a clinical trial, the first question you may think of is: Will this be safe?

Participant safety is the number one concern of all physicians and researchers conducting clinical trials. Many laws, requirements and safety commissions have been established to ensure every single participant in a clinical trial remains safe throughout the entire trial.

How You Are Kept Safe

1. Informed Consent

The first step to participant safety in clinical trials happens before the trial even begins with the informed consent process. All trials must have this step, in which a member of the research team will explain to the potential participant exactly what the trial will entail – including possible side effects or risks from the treatment – and give the individual the chance to ask questions. Participation in a clinical trial is completely voluntary, which is why this step is so important[1].

2. Rules and Regulations

The government has passed many laws and established multiple commissions that are solely dedicated to participants‘ protection during trials. They have constituted that anyone in a trial always has the option to withdraw at any time, and that all participants are monitored by medical professionals throughout the entire trial[2]

3. Approval

All clinical trials are also required to be reviewed and approved by Institutional Review Boards (IRBs), which are boards made of scientists, doctors, and regular people who review the entire study and its protocol and determine whether every part of the study is safe and ethical for humans to participate in[3].

4. Continuous Safety Monitoring

Trials also have Data and Safety Monitoring Committees, which monitor the study while it is in progress and if the study is not working or is resulting in harm to participants, they will halt the study[4].

“You are followed very closely at every visit with safety testing,” Amanda Salisbury, regional director of clinical operations for Wake Research in North Carolina, said. “Some examples are ECGs, labs, physical exams, etc. during the study. Patients are monitored closer while participating in a clinical trial than by their normal primary care physician. “

Risks vs. Benefits

An attractive couple with brown skin, hair, and eyes affectionately embrace; the husband smiles and the wife kisses his cheek.Participating in a clinical trial will have some risks, such as experiencing side effects from the treatment or therapy being examined, which can range from mild to severe. But you will always be aware of whatever risks a trial might present, Salisbury said.

“These are presented during the informed consent process,” she said. “Potential participants are allowed to take the consent that lists risks and benefits home to discuss with other family members and even their own primary doctor.”

Clinical trials also present large benefits, such as the potential improvement of your medical condition through access to new treatments and therapies that can help you and others. You’ll also receive no-cost study-related drugs, study-related medical care by highly trained medical professionals and possible compensation as well[5].

Ultimately, it is important for anyone considering signing up for a clinical trial to know that everything possible will be done throughout the process to ensure they stay safe and do not experience anything harmful.

“Phase 2-3 clinical trials are performed on individuals that have been diagnosed with the condition the trial is treating, and only if the potential benefits outweigh the potential risks,” Dr. Marieke Cajal-Berman, director of patient engagement for Wake Research, said.

Deciding to participate in a clinical trial is a big decision, but it is something that can provide a lot of benefits to you and to the population.

“Participating in a clinical trial is always voluntary and a participant can withdrawal from the study at any time,” Salisbury said. “It is up to each participant to decide if participating in a clinical trial is right for them.”

Staying Safe During COVID-19

The COVID-19 (Coronavirus) crisis has brought all new risks and fears to everyday life. When venturing to the grocery store carries its own risks, coming in for a clinical trial may seem even more frightening.

But clinical trials are essential businesses; they are important in helping individuals receive treatment for chronic conditions and are vital in discovering new treatments and prevention for diseases, including COVID-19.

When you come in for a clinical trial, your health and safety is Emerging Medical Research and Wake Research’s top priority. In accordance with CDC guidelines, we have the following health and safety protocols in place:

  • Minimizing exposure at our research sites and facilities – All trial volunteers, employees, vendors and sponsors will have their temperature checked prior to entry to our facilities. Volunteers will go through an additional phone and in-person questioning before conducting a study visit. We have also limited all non-essential access to all our facilities and are testing our employees periodically. Our intent is to minimize potential exposure while ensuring clinical trial continuity to the maximum extent possible.
  • Virtual appointments – When possible, appointments can be done virtually so the patient or participant does not have to come into the office.
  • Enhanced cleaning protocols – We have increased the frequency of disinfecting and cleaning services at our research sites and have provided additional hand sanitizer stations.
  • Education and communication – We are in close communication with our potential and on-trial volunteers and are providing them with information about how they can stay safe and healthy during this time. We are also preparing them for what to expect when they visit our facilities, given our enhanced screening and safety measures. Our employees receive frequent updates on the COVID-19 situation, including precautionary tips and best practices to stay safe.

[1] “Clinical Trials: Benefits, Risks, and Safety.” National Institute on Aging. U.S. Department of Health and Human Services, May 17, 2017. https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety.
[2] “Tuskegee Study – Research Implications, How Tuskegee Changed Research Practices.” Centers for Disease Control and Prevention. U.S. Department of Health & Human Services, December 14, 2015. https://www.cdc.gov/tuskegee/after.htm.
[3] Ibid.
[4] “Clinical Trials: Benefits, Risks, and Safety,” (2017).
[5] “Patient Education: What Are Clinical Trials (The Basics).” UpToDate. UpToDate, Inc. . Accessed February 12, 2020. https://www.uptodate.com/contents/what-are-clinical-trials-the basics?search=clinical%20trial%20patient%20safety&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.

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