Vaccines, treatments, cures, and other health technologies must undergo clinical trials. Clinical trials are critical for health innovation and have enabled the creation of antibiotics, cancer treatments, and even the COVID-19 vaccine.
Clinical trials are health research studies conducted on people in a controlled, medical setting to provide knowledge of the efficacy, dosage, response and side effects of a new product. There are many different types of clinical trials, such as:
- Treatment trials: Test the effectiveness of new drugs or treatments1
- Prevention trials: Examine ways to prevent people from developing a disease1
- Screening trials: Determine the best way to test for certain conditions or diseases1
We’ve seen history being made with the rapid vaccine turnaround for the COVID-19 vaccines this past year, because people were willing and eager to participate in this research. In July 2020, Pfizer-BioNTech vaccines went through phase 3 clinical trials with 43,448 participants from 5 different countries2 and only 6 months later, published their results in December 2020, even though it would normally take 1-4 years3 to conduct a similar trial! We owe a big thanks to science, particularly to the researchers who worked around the clock, but also to the amazing research participants who tested the safety, required dosage and efficacy of the vaccine before it became publicly available.
55% of failed clinical trials, fail because they aren’t able to recruit enough participants4
Ultimately, treatments, cures, and preventative care measures wouldn’t exist without people who participate in clinical trials. Participation in clinical research is critical to actually developing treatments, technology, and vaccines as 55% of failed clinical trials fail because they aren’t able to enroll enough participants.4 Without these volunteers, treatments and improved care is delayed.
Understanding the Phases of Clinical Trials
Clinical trials are conducted in phases.5 The goal of clinical trials becomes more refined as they progress through these phases; starting with simply proving that a treatment does not do any harm, to proving that it is actually effective as a treatment or cure.5
Before clinical trials begin, there is a pre-trial process which involves testing on animal subjects to determine if a phase I clinical trial should be conducted. Trials usually have 4 phases, each with a different goal:
- This phase typically involved between 20 to 100 participants and runs from a week to several months3
- The goal is to make sure that a technology, treatment, etc. is not harmful3
- This is the riskiest of all the clinical trial phases
- Participants are closely monitored by trained medical staff when there is any delivery of drugs or treatments and when lab work is completed
- One source notes that participants in this phase are typically paid between $50-300 per day or visit6
- This phase typically involves several hundred participants and lasts between several months to 2 years
- The goal is to help scientists learn more about how safe a scientific technology or treatment is and how well it works
- This phase involves thousands of people, up to 3,000, and typically lasts between 1-4 years
- The goal is to determine that a scientific treatment or technology is effective
- Participants are monitored for any side effects and help scientists determine if the treatment can be taken to market
- This phase involves several thousand people and typically lasts over a year
- The goal is to determine the long-term benefits and side-effects of a treatment or technology
- This phase takes place after a treatment is already available to the public
Why Do Clinical Trials Need Healthy Volunteers?
Healthy volunteers are extremely important for clinical trials for various reasons. 3 areas where they have a particularly important impact are:
- Phase I Treatment Trials: Phase I clinical trials for drug treatments or cures aren’t suitable for people with underlying health conditions because there is an increased risk for participating and it is unethical for scientists to recruit these people for the riskiest part of the clinical trial process. Healthy volunteers are required for this stage because individuals that are sick are not able to participate. Risk is involved, but volunteers are always monitored by medical staff to make sure that serious harm is minimal and rare. A systematic review of 475 clinical trials actually found that participation can cause mild to moderate harm but there is low risk for serious harm.7
- Prevention Studies8: Prevention trials can help scientists learn about factors that can prevent the development of a condition or disease. Healthy volunteers would be those that don’t have the condition that is being investigated; for example, cancer prevention trials might examine how a diet change might reduce a healthy volunteer's risk of getting cancer. Healthy volunteers, in this example, would be defined as somebody that doesn't have cancer.9 These volunteers are necessary because they help scientists learn about ways to help not just those that are afflicted by a certain condition, but those that might be at risk of it, which might even include you.
- Vaccine Development: Vaccines are a specific form of preventative care that are meant to keep a healthy individual from contracting an illness or disease. Healthy volunteers are required for this research because much of the population is defined as ‘healthy.’ The phase III Pfizer BioNTech clinical trials, for example, recruited participants that had no evidence of having contracted the coronavirus, and also those that had shown evidence that they had contracted it previously.10 The parameters for ‘healthy’ can be very broad - in this case it was a ethnically and medically diverse group of participants over 16 years old10 - which is why healthy volunteers are very important; they make up most of the population and are required for a vaccine to complete clinical trials and be approved for market.
The need for healthy volunteers from ALL backgrounds is also very important for clinical trials because biases still exist for these clinical trials. One study found that globally the percentage of phase I cancer trial volunteers that were White was 62% but in the USA the percentage of White participants was 84%.11 Unfortunately, this is the case for most clinical studies in the USA; about 80-90% of the enrollment for drug clinical trials is made up of White participants.12
An anti-stroke drug is prescribed at 5.0 mg even though that is only a compatible dose for White patients13
This becomes extremely problematic because it means that drugs can get approved after being tested in a primarily White population, meaning we don’t know how any other ethnic and racial groups will react to the medication. This is not simply a possibility, but a fact.
For example, a drug that’s used to treat people that have had blood clots and prevent stroke is, on average, prescribed at a starting dose of 5.0 mg by doctors.13 However, this dosage is only valuable for White people, as they require, on average, a 5.1 mg dose.13 Asians, on the other hand, only require a 3.4 mg dose on average, while Black patients, on average, require 6.1 mg.13 Most people, except for White patients, are misprescribed this drug likely because the clinical trials were conducted on a primarily white population.13
Why Should Healthy People Participate in Trials?
There are many reasons why researchers need healthy volunteers for their studies but it’s also beneficial for you to participate in them too!
- Financial incentive: One big benefit for participating in clinical trials is the financial incentive. You are taking on (supervised) risk which means that researchers will typically pay you quite well for your time; usually hundreds of dollars for your completion of their study. One study found that people who participated in 1-2 phase I clinical trials per year, on average, earned about $4000 USD.14
- Philanthropy: As valuable as money is for philanthropic endeavours, our time is just as valuable, if not more! By participating in clinical trials you could contribute to potential treatments for serious health conditions and help others while helping yourself too; all by donating your time.
- Contribute towards inclusive research: Your participation can help create a more inclusive sample for clinical research. Your contribution to clinical research could help prevent issues that have arisen due to lack of diversity in data, such as in the case of anti-stroke medication.
The power of participating in clinical trials is revolutionary; the rapid development of the COVID-19 vaccines has shown us how quickly science can change our lives. Your participation in clinical research drives faster health innovation and you get to help yourself while helping others at the same time. And it’s easier than ever to participate in this research with Honeybee, just check out the clinical trials you can enroll in today.
Connects the community with research. Honeybee is a web and mobile app to participate in research, discover yourself, and earn cash and rewards.
1. Types & Phases of Clinical Trials. Published June 17, 2021. Accessed July 23, 2021. https://www.lakeridgehealth.on.ca/en/trainingandresearch/Types---Phases-of-Clinical-Trials.asp
2. Fact check: COVID-19 vaccines did have clinical trials | Reuters. Accessed July 23, 2021. https://www.reuters.com/article/uk-factcheck-vaccines-clinical-trials-idUSKBN2A22D3
3. Clinical Trials Phases: Definition of Phase 1, 2, 3 & 4 | pfpfizeruscom. Accessed July 23, 2021. https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases
4. Desai M. Recruitment and retention of participants in clinical studies: Critical issues and challenges. Perspect Clin Res. 2020;11(2):51-53. doi:10.4103/picr.PICR_6_20
5. Clinical Trial Phases: What Happens in Phase 0, I, II, III, and IV. Healthline. Published February 22, 2018. Accessed July 23, 2021. https://www.healthline.com/health/clinical-trial-phases
6. FAQ | How do Paid Clinical Trials Work and How Much Clinical Trials Pay? Accessed July 23, 2021. https://clinicalhero.com/faq/
7. Johnson RA, Rid A, Emanuel E, Wendler D. Risks of phase I research with healthy participants: A systematic review. Clin Trials. 2016;13(2):149-160. doi:10.1177/1740774515602868
8. Types of Cancer Clinical Trials - National Cancer Institute. Accessed July 23, 2021. https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/types
9. US Department of Health and Human Services; National Institute of Mental Health. If You Want To Find Ways To Prevent Cancer...: Learn About Prevention Clinical Trials: (411312005-001). Published online 2004. doi:10.1037/e411312005-001
10. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | pfpfizeruscom. Accessed July 23, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
11. Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials | Future Oncology. Accessed July 23, 2021. https://www.futuremedicine.com/doi/10.2217/fon-2020-1262
12. EDITORS T. Clinical Trials Have Far Too Little Racial and Ethnic Diversity. Scientific American. doi:10.1038/scientificamerican0918-10
13. Johnson JA. Ethnic Differences in Cardiovascular Drug Response: Potential Contribution of Pharmacogenetics. Circulation. 2008;118(13):1383-1393. doi:10.1161/CIRCULATIONAHA.107.704023
14. Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment? - Jill A Fisher, Lisa McManus, Julianne M Kalbaugh, Rebecca L Walker, 2021. Accessed July 23, 2021. https://journals.sagepub.com/doi/full/10.1177/17407745211011069