How You Can Help Advance Medicine With Clinical Trials
Have you ever wondered how new drugs, medical practices, devices, or treatments come to be used widely? In order for them to go public, they need to undergo rigorous clinical trials and pass the federal guidelines successfully. However, researchers need to provide information to any participants and let them know exactly what the hoped outcome of the trial is, any potential dangers or side effects, and the participant must be able to give informed consent before going forward. Informed consent is important enough that it now has its own section (8.02) in the ninth revision of the American Psychological Association’s Ethical Code. So how do clinical trials work? What are they used for? What should I know if I’m about to participate in a clinical trial?
How Clinical Trials Work
Clinical trials are one of the last steps in the research process, whether it’s clinical drug development, medical research studies, or something else. They seek to find out whether the device, treatment, or plan of action is safe and will work on humans. They can also illuminate what kind of approach is most effective for a specific illness or for a certain group of people. Clinical trials are crucial in providing the most accurate data for those who must make decisions regarding health care.
A clinical study and clinical trial are research-focused, so the studies must adhere to strict standards that protect the participants and yield results that are reliable and consistent. Interestingly, though almost half of respondents agreed that participating in clinical trials was as valuable to the health care system as donating blood, over 95% of respondents hadn’t ever participated in a clinical trial.
Clinical trial standards are also ever changing. For example, in 1999, a trial lasted around 460 days, and in 2005, the average clinical trial lasted around 780 days.
What Can Clinical Trials Be Used For?
Clinical trials are most often used for furthering medical knowledge and treatment methods and improving patient care. It only occurs if doctors aren’t certain if a new method or device will be effective for humans and want more concrete results. There are generally three outcomes. Either there will be a positive result that proves the treatment, method, or device is helpful in treating patients, a negative result that shows unexpected harm could occur when used on people, or there’s no result at all, prompting researchers to go back to the drawing board.
In any case, these results can be helpful. A positive result could result in the FDA greenlighting a drug or treatment that could save lives. On the other hand, they could recommend that certain treatments never be used or specifically state what harmful side effects could happen while taking the drug or over the course of treatment, thanks to the clinical trial results.
What Do I Need to Know Before Participating in a Clinical Trial?
In all cases, you need informed consent. If you’re under 18 or researchers want to use your child who is underage, it’s a legal requirement to get consent from their parent or guardian. If you’ve been asked to participate in a trial, it may because you have a disease or condition that they’re researching. Make sure you’re aware of all the risks and possible outcomes, including potentially negative ones, but rest assured that a medical team will be providing you care along the way and monitoring your health carefully.
Know your resources if you feel that your rights aren’t being protected. The Institutional Review Board reviews all the protocol before the trial starts, but you can contact the Office for Human Research Protections or appeal to the sponsors of the trial, who can stop a trial early if there are evident harmful results.
Also keep in mind that even when you’ve given your informed consent, you have the right to remove yourself from the study at any time, for any reason. And you have the right to be informed about any new risks or results over the course of the trial.
Whether you’re participating in a phase 1 clinical trial or a later trial, know your rights and the assistance you’re providing not just the medical community, but the world at large.