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October 19, 2022

Frequently Asked Questions in Joining a Clinical Trial

Introduction

Contrary to popular belief, clinical trials are not entirely new. In fact, it has been around for almost 300 years. One of the earliest known clinical trials in the modern era is performed by a physician named Dr. James Lind. In 1747, Dr. Lind performed a comparative trial about what might be the most effective cure for scurvy [1]. This innovative approach paved the way to form the essential elements of a controlled trial that is still being recognized up to this day. But if clinical trials have been around for a significant amount of time, why are many people still uneducated about this?

Lack of Awareness

According to a published report by the National Institutes of Health (NIH) on their website in 2016, 85% of patients were clueless or doubtful about the option of participating in a clinical trial at the time of their diagnosis [2]. It is a staggering percentage considering that 2016 is already in the digital age where information is free, accessible, and abundant. But the numbers didn’t get lower.

 

As cited in the article written by Richie Kahn, MPH “Clinical Trial Awareness or Lack Thereof” (2022) , 90% of patients never had a conversation or an endorsement with their doctors about participating in a clinical trial [3]. Surprisingly, as also mentioned in another study , the reasons why most physicians or even nurses don’t mention anything about joining a trial are lack of familiarity with trial referrals and inadequate access to trial information [4].

 

While it is true that the internet and mainstream media have the power to inform and influence the public about what clinical studies are, it is also true that clinical operations experts also have the responsibility to spread awareness and bridge the gap between clinical operations and potential patients or participants.

Frequently Asked Questions (FAQs)

1.   If I’ll participate in a clinical study, will I be treated like a guinea pig?

No. Patients are treated with the utmost respect and care. Unlike specimens like rats or guinea pigs, humans are not entirely dispensable. The clinical operations staff highly protect their subjects’ dignity, health, and overall well-being. This safeguarding isn’t only a moral obligation but a legal one, too.

 

There are a set of rules, regulations, and standards that every clinical trial must uphold in order to continue its operation. These laws are strictly enforced by the federal government in order to protect the participants from getting more risks than benefits in joining a clinical trial. Aside from the government, there are also independent associations that have the authority to evaluate and control how patients should be treated. Some of these bodies are the Institutional Review Boards (IRBs) and Data & Safety Monitoring Committees.

 

2.   What are the dangers of participating in a clinical trial?

As the National Institutes of Health (NIH) pointed out on their website , participating in clinical trials and getting new treatments may induce side effects or distress [5]. Moreover, the treatment that is being introduced to a patient might not work at all. Ultimately, joining a clinical trial might bring discomfort due to several tests, procedures, or dosages that a patient might take during the course of the study.

 

Joining a clinical study might sound risky, but it has astounding benefits, too. According to the same article published by the NIH on their website, recruited patients in a clinical trial can receive free medical care, free follow-up check-ups, support groups, reimbursement for the expenses incurred during the trial period, and according to the regulations monetary and other non-monetary compensations.

3.   Who can join clinical trials?

Patient volunteers, healthy volunteers, and or a mixture of both can join clinical trials granted that they fit the criteria of qualified participants in a particular clinical trial. According to an article on the National Institutes of Health (NIH) website updated last March 24, 2022, a clinical trial’s protocol dictates what qualities or standards should a patient possess in order to take part in the research. This is strictly followed in order to not tamper with or alter the course of the experiment which may lead to the study’s failure [6].

 

The criteria for eligibility aren’t the same for every clinical trial. It varies depending on what the study needs to focus on. Some factors can include but are not limited to age, race, sex, type, stage of disease, and other comorbidities. As emphasized in the same article, the eligibility criteria aren’t used to reject participant applications but to protect the welfare of other participants as well as the whole study. Also, the criteria can help clinical researchers get the data that they need.

4.   Why should I participate in a clinical trial?

The primary purpose of clinical trials is to discover new and effective ways of treating diseases through drugs, surgery, or devices. This also includes prevention and approaches to certain medical conditions. In short, clinical trials are an integral part of medical breakthroughs. If a person wishes to participate in a trial, not only is he giving chance for himself but also giving chance to the scientific community to create more ways in making life better by discovering more treatments or health options for certain diseases.

 

Healthy volunteers take part mainly for the purpose of medical advancements. People with existing health conditions take part to make their lives an instrument of change while having the opportunity to receive extra medical attention through clinical trial staff and medical professionals. Whatever the case may be, clinical trials are conducted to improve the quality of life.

5.   How can I join clinical trials?

As reported by the National Institutes of Health (NIH) on their website , the NIH conducts clinical research about several medical conditions including cancer, Alzheimer’s disease, infectious diseases, and neurological disorders, if a potential patient wants to participate in one of these trials, he or she can visit ClinicalTrials.gov [7].

 

Clinical Trials .gov is a searchable registry and results database of government-backed and privately supported clinical trials that are being held around the world. The site can provide a certain trial’s purpose, criteria of participants, locations, contact information, and other relevant details. However, it is also highly recommended that the decision to join a trial should be consulted and influenced by health care professionals.

 

Conclusion

Despite being a multi-billion industry and having a rich and colorful history, clinical trials still remain a mystery even in today’s society. To spread awareness and inform the public of the significance of such scientific studies, the clinical science community, government, and media should work hand in hand in order to get rid of, or at least minimize, the public’s fear, uncertainty, and doubt towards joining a clinical trial.

References

  1. Bhatt A. Evolution of clinical research: a history before and beyond james lind. Perspect Clin Res. 2010;1(1):6–10.

 

  1. The need for awareness of clinical research [Internet]. National Institutes of Health (NIH). 2015 [cited 2022 Oct 1]. Available from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research

 

  1. Clinical trial awareness ... Or lack thereof - glaucoma today. [cited 2022 Oct 1]; Available from: https://glaucomatoday.com/articles/2022-jan-feb/clinical-trial-awareness-or-lack-thereof

 

  1. Stempel D. New tufts research explores barriers to clinical trial recruitment success [Internet]. Patientcentra.com. [cited 2022 Oct 1]. Available from: https://www.patientcentra.com/patient-recruitment-insights/tufts-research-barriers-clinical-trial-recruitment-success

 

  1. Clinical trials: Benefits, risks, and safety [Internet]. National Institute on Aging. [cited 2022 Oct 1]. Available from: https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety

 

  1. Who can participate [Internet]. NHLBI, NIH. [cited 2022 Oct 1]. Available from: https://www.nhlbi.nih.gov/research/clinical-trials/participating

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