Guinea pigs or the hope of science: the pros and cons of participating in clinical trials in the US
Clinical trials are studies of health conditions, disease dynamics, and treatment options. These studies involve patients who have voluntarily agreed to provide themselves to medical scientists. Participation in such studies has many potential benefits, but the risks should not be forgotten. So is it worth the risk? You can read about the pros and cons of participating in clinical trials on the website National Institute on Aging, USA.
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"I wanted to benefit future generations"
One day, 68-year-old Adin Asher felt a suspicious lump in her left breast. Her mammogram two months earlier had been negative, but now that she had it checked again, there was no doubt. It was breast cancer.
“I wanted to do everything I could to save my life,” Adin explained. She worked as an advocate for children with cerebral palsy, but she said it was “terrifying to be your own advocate and do everything you can to fight for your own survival.” She was acutely aware of how breast cancer impacted her community (African Americans have the highest mortality rate of any racial group). So her first step was to find an oncologist she could trust.
Adin’s friend had been treated by Dr. Joseph Sparano at Albert Einstein Cancer Center for 20 years for advanced cancer. Adin met with the doctor, and they eventually discussed a clinical trial called TAILORx, which involved women with early-stage breast cancer. The study was testing whether hormone therapy alone was as effective as hormone therapy combined with chemotherapy.
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Adin returned home and thought about what being a part of TAILORx could mean for other women and all African Americans.
“My participation in a clinical trial now could benefit someone like me in the future,” she decided. Adin joined the study in 2008, and in 2018, the results of the study changed treatment guidelines: 70% of women with this common type of breast cancer do not need chemotherapy after surgery.
Coordinated by the NCI's National Clinical Trials Network (NCTN) group, Dr. Joseph Sparano said, "The landmark TAILORx study has given us more clarity about treatment—we're probably overtreating some patients and undertreating others."
Adin was in the group that received chemotherapy. Now in her 12s and XNUMX years cancer-free, Adin has no doubt that she made the right decision.
"Doctors don't do anything without patients' knowledge or force them to agree to trials. For me, it was a conscious step. I knew that such research was important for other patients."
Breaking stereotypes
“Some people think they will be guinea pigs,” Dr. Raymond Osarogiagbon said, voicing the concerns of members of rural and minority communities. He recalled conversations with one woman’s family when he approached her about participating in the trial.
“Thirty relatives came with her – angry, scared and wanting to know why I wanted to experiment on their mother,” the doctor noted. When he explained how the tests were actually conducted, their fears were dispelled and the woman agreed. Ten years have passed since then, and she feels well. Some of her relatives even asked if they could take part in some of the tests.
Where did fears come from?
It must be said that concerns about clinical trials are not unfounded. There have indeed been cases in the past where subjects were treated almost like “guinea pigs.”
One notable example is the Tuskegee Syphilis Study conducted by the United States Public Health Service (USPHS) between 1932 and 1972.
The clinical trials of syphilis, known as the Tuskegee Experiment or the Tuskegee Syphilis Study, were among the most controversial medical experiments in U.S. history. Numerous ethical and human rights violations were committed during the experiments.
The experiment began in 1932. The goal was to study the natural history of untreated syphilis in African-American men in the Tuskegee, Alabama, area. About 600 people initially participated in the study. Of those, 399 had syphilis and 201 did not. Researchers promised participants free medical examinations, meals, and burial services, but did not inform them of the purpose of the experiment or whether they had syphilis.
The scandal of the experiment was that an effective treatment for syphilis, penicillin, had been available since 1947. However, participants with syphilis were deliberately not prescribed this drug in order to track the natural progression of the disease. Participants were not informed of their diagnosis or treatment options, which led to long-term health consequences for not only them but their entire family.
The experiment was made public only in 1972, when journalist Jean Heller published an article about it. The public was shocked by the facts of deliberate refusal of treatment and deception of participants. After this, the research was stopped, and legal proceedings began. In 1974, the United States passed the Law on Research Morals and the Rights of Participants in Clinical Research. In 1997, President Bill Clinton made an official apology to the victims and their families.
The Tuskegee Experiment scandal was a turning point for medical ethics and the rights of clinical research participants.
But every cloud has a silver lining. This incident contributed to the creation of the institute иinformed consent, which requires participants to receive full information about the risks and purposes of the experiments. The National Institute of Bioethics was founded to develop ethical standards.
These events led to the creation of laws that provide clinical trial participants with several levels of protection.
Vital access to treatment
While clinical trials can provide vital access to treatment, there are “historical moments that people look back on when the research community didn’t serve people as well as they should have, and we continue to carry that burden,” said Dr. Raymond Osarogiagbon, director of the multidisciplinary thoracic oncology research program at Baptist Cancer Center in Memphis, Tennessee.
Raymond sees patients from states with the highest rates of lung cancer cases and deaths, as well as "some of the worst social determinants of health: high rates of tobacco use, poverty, and poor health care infrastructure."
Clinical trials are helping to expand access to cancer treatments by offering patients options like immunotherapy that did not exist 50 years ago.
They see about 12 patients a month, many of whom are underserved.
For Patty, a Spanish translator who helps patients, her work is important.
“What’s the point of having the best doctor giving you the best advice if you can’t understand it?” she said, noting that older patients, those without insurance, immigrants, or those who don’t speak English may be rejected by the health care system. For them, clinical trials offer a real chance to get effective treatment.
Benefits of Participating in Clinical Trials
- You will have the opportunity to help scientists better understand your disease, improve treatments, and improve ways to prevent it in the future.
- You may feel like you are taking a more active role in your recovery.
- You can learn more about your disease or condition.
- You can get information about support groups and other resources.
Additionally, some people participate in clinical trials because they hope to gain access to a potential new treatment for a disease before it becomes widely available.
What are the potential risks of participating in clinical trials?
- Some physical tests may increase the chance of injury, and X-rays may cause a small increase in the risk of cancer.
- Participating in a study will cause some inconveniences for you. For example, you may need additional or longer doctor visits, more procedures, complicated instructions for taking medications, or a hospital stay.
- Experimental treatments sometimes cause side effects (ranging from mild to serious).
- An experimental treatment may not work or may be no better than standard treatment.
- In trials that test an experimental treatment, such as a new drug or device, you may not be in the group that gets it. Instead, you'll be assigned to a control (or comparison) group. In some studies, the control group gets a placebo. In many cases, you won't know this until the end of the trial.
Participant privacy is an issue in any experiment. Research sponsors or safety experts may have access to medical information related to a particular study. There are safeguards in place to ensure that researchers tell potential participants what information may be shared and how their privacy will be protected before they agree to participate in the study.
What happens if a clinical trial ends earlier than planned
Most clinical trials go according to plan from start to finish. However, sometimes researchers end them early. Clinical trials can be paused or stopped entirely for a number of reasons:
- There is clear evidence that one intervention is more effective than another. When this happens, the trial can be stopped so that the new treatment can be made available to other people as quickly as possible.
- A trial shows that a treatment does not work or causes unexpected and serious side effects.
- Researchers cannot enroll enough people in the trial to provide meaningful results.
Even if a clinical trial ends early, it can still provide valuable information to researchers. For example, scientists can gain insight into how best to design and conduct clinical trials in a particular area of research. In some cases, health information collected during a trial leads to potential new treatments that researchers can test in the future.
How the safety of clinical trial participants is ensured
Every clinical trial follows a careful study plan called a protocol.
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Safeguards to protect clinical trial volunteers include institutional review boards, informed consent, data and safety monitoring boards, and study monitoring review boards.
- Most clinical trials in the United States must be approved by an institutional review board (IRB). The IRB is made up of doctors, scientists, and members of the public who ensure that study participants are not exposed to unnecessary risks.
- Informed consent helps protect participants. Informed consent is the process by which you learn basic facts about a study before you decide whether to participate. You can ask questions, request additional information, or withdraw from the study at any time.
- Clinical trials that test an intervention are closely monitored by a Data and Safety Monitoring Board. The board is made up of experts who review the results of the study as it is conducted. If they determine that the experimental treatment is not working or is causing harm to participants, they can stop the study early.
- Observational Research Monitoring Boards monitor the safety of observational studies with large or vulnerable populations or risks associated with tests or standards of care.
NIH conducts clinical research into many diseases and conditions, including cancer, Alzheimer's disease, allergies and infectious diseases, and neurological disorders.
Where to find clinical trials
If you decide to participate in clinical trials, you can find one that is suitable for you on the following websites:
Before participating in a study, talk with your doctor to learn about the risks and potential benefits.
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