Would you want to drive a car that hadn’t gone through safety tests, or ride in an airplane that hadn’t been checked by the Federal Aviation Administration? These vehicles are incredibly important tools in our lives, and the stakes are high. It’s important to get them right in order to maximize our safety.
Medications are similar. In the US, the Food and Drug Administration (FDA) is the agency that makes sure the medications, vaccines, and medical devices you use are safe and work the way they should. The FDA relies on clinical research — specifically, results from clinical studies — to do that.
Despite the deep and troubled history of clinical research within and outside of the US1, particularly amongst Black communities and other communities of color, clinical research is now designed to help protect historically marginalized groups. Keep reading to learn more about those protections and why it’s important for people like you to participate in clinical research.
What is the purpose of clinical research?
People throw around the term “research” often, but what does it actually mean? Research consists of planned studies that are designed to answer specific questions. There are two main categories of research when it comes to medications: preclinical and clinical.
- Preclinical research answers the question: “Is this treatment safe?” Preclinical research usually involves animal testing. If the medication is deemed safe, then it may enter the clinical research process.2
- Clinical research answers the questions: “Is this treatment safe in people?” and “Does this treatment work?” In other words, does it do what the drugmaker expects it to do, and if so, how well? Clinical research involves testing the medications in healthy people to make sure it’s safe for human use, and then testing it in patients with a particular illness or condition to determine the drug’s effects on the disease.3
While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people.
- Food and Drug Administration3
During clinical research, scientists follow a step-by-step process to test a hypothesis — an educated guess about how the medication works. Testing their hypotheses helps scientists figure out whether their ideas are actually true. Here are a few examples of the types of questions clinical research could be designed to answer:
- Does Drug A treat Condition X?
- Is Drug A better than Drug B for treating Condition X?
- Are fewer side effects associated with Drug A, compared to Drug B?
Why should Black communities participate in clinical research?
Inclusivity is critical in clinical research. Scientists conduct studies to figure out how well a medical, surgical, or behavioral treatment works in real people.
If scientists study the effects of a medication for a certain condition, the results of that study give the FDA a strong idea of how safe and effective that medication is. The more diversity there is in the people who are enrolled in a study, the more confident researchers and the FDA can be that the medication’s safety and effectiveness are consistent across all those different types of people. And if there are any differences, the researchers are more likely to notice them.
It’s equally important to acknowledge why some people may be hesitant to participate in clinical research. The history is clear. In the past, researchers have taken advantage of Black, Indigenous, and Latinxo communities by experimenting on people within these communities without their permission. In each of these cases, individuals and entire communities were harmed, and this harm has been passed down across generations.
Now, here’s the challenge for today’s generations.
We are fully aware of the past abuses that have occurred. And we’re also aware of the importance of inclusivity and representation of Black communities in clinical research. With those two conflicting ideas in mind, we are responsible for breaking the cycle of mistrust and exclusion from medical progress.
Many of our ancestors didn’t have the opportunity to participate in clinical research in a way that would benefit their communities. They were forced to do so, primarily for the benefit of the people who experimented on them. But Black individuals today do have the opportunity to benefit from clinical research. And if we choose not to be involved, we actually waste the opportunity to improve the health of our communities.
How are people who participate in clinical research protected?
A significant amount of work has gone into revamping the clinical research process so that it’s more equitable, just, and fair, and so that history doesn’t repeat itself. There are a few specific measures in place that help protect clinical research participants, including Black communities and other communities of color:
- The FDA – The FDA has put into place several policies, rules, and regulations that guide the clinical research process. These policies are intended to make sure that every aspect of clinical research prioritizes the safety and fair treatment of participants.
- Institutional review boards (IRBs) – IRBs are responsible for protecting clinical research participants. These committees review and keep tabs on any scientific research that involves human subjects. IRBs determine whether a clinical study is allowed to proceed or not, and whether changes must be made to the study plan, often called a protocol.4 Major changes — or modifications — may be related to the way the study is designed, the goals of the study, or any research activities that could influence the risks and benefits of the study.5 For example, IRB could request changes to who is allowed to be included in or excluded from the study, or could ask for changes to the dose of a drug that’s given during the study.
- Informed consent – Informed consent is another protective element within the clinical research process — specifically recruitment. Informed consent means that anyone who decides to participate in a clinical study does so with an understanding of why the research is being done, what their role is, how the study works, and what the potential risks are.6 They must also acknowledge their understanding that participation is completely voluntary and participants can choose to stop participating at any time, with no penalty. Informed consent is a very detailed, thorough process, and study participants are required to sign a consent document that indicates their agreement to participate.6
Conversation starters: Which of these protective measures are you most interested in learning more about, and why?
What are the most important steps in the clinical research process?
When it comes to clinical research, there are quite a few steps researchers must follow.3,7
Step 1: Choose a research question. Simply put, the researcher must decide what question about a medical, surgical, or behavioral treatment they want to answer.
Step 2: Design a study that can answer the question. A clinical study must be conducted according to a specific protocol, and researchers must develop the protocol before the study can even be allowed to begin. Designing the study involves deciding things like:
- how many people should participate
- how participants should be grouped
- what kinds of treatments participants will get (and in what doses if medications or vaccines are involved)
- what kinds of tests will be performed
- how long the study will last
- what criteria will be used to determine whether the study should continue or be stopped early, and much more.
Step 3: Apply for IRB approval. Keep in mind that IRBs protect people like you who are involved in clinical research, and an IRB must approve the study protocol before a study can begin.
Step 4: Recruit and enroll participants into the study, and conduct the study. Once a study is authorized to proceed, researchers will need to recruit participants. As you learned above, getting informed consent from participants is a key part of the recruitment and enrollment process.
Step 5: Analyze and distribute the results. Once the study ends — and to some extent, even while it’s still going on — scientists gather results from the study and analyze them. They use the results to determine the answers to their original research question and healthcare providers determine how to apply those results to patient treatment in the real world.
By the way, there are several phases of clinical studies a treatment must go through. This video from the National Cancer Institute explains them in more detail, using cancer treatments as an example.8
How can you learn more about clinical research and your role in it?
If you’re ready to discover what clinical studies you might be eligible to participate in, ask your doctor if they know of any clinical studies that might be available.
If you’re still in the exploratory phase and want to learn more about clinical studies, there’s no shortage of information. Consider these resources from the National Institutes of Health (NIH):
- Website on clinical studies and participation
- Glossary of clinical research terminology
- ClinicalTrials.gov, a website that provides free access to information about a wide variety of clinical trials
References
- Scharff, D. P., Mathews, K. J., Jackson, P., Hoffsuemmer, J., Martin, E., & Edwards, D. (2010). More than Tuskegee: understanding mistrust about research participation. Journal of health care for the poor and underserved, 21(3), 879–897. https://doi.org/10.1353/hpu.0.0323
- Food and Drug Administration. Step 2: Preclinical Research. https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research
- Food and Drug Administration. Step 3: Clinical Research. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
- Food and Drug Administration. Institutional Review Boards Frequently Asked Questions https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
- Columbia University. Institutional Review Board: Common Types of IRB Modifications. https://www.tc.columbia.edu/institutional-review-board/irb-blog/common-types-of-irb-modifications/
- Food and Drug Administration. Informed Consent for Clinical Trials. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
- UW Medicine Health System. Steps for Conducting Clinical Research. https://depts.washington.edu/anesth/research/irb/steps.shtml
- National Cancer Institute on YouTube. What are Clinical Trial Phases? https://www.youtube.com/watch?v=dsfPOpE-GEs
