LVHN's Network Office of Research and Innovation has the info you need to know
While many people have heard about clinical trials, there are a lot of myths surrounding them and their benefits.
To set the record straight, Leslie Baga, administrator of Lehigh Valley Health Network (LVHN)’s Network Office of Research and Innovation (NORI), shares information about clinical trials and their importance:
“Clinical trials are research studies that evaluate medical, surgical and sometimes behavioral interventions,” Baga says. “Clinical research is the best way to find out if certain treatments, devices, vaccines and screenings are safe and effective.”
In the United States, all medical treatments must go through clinical trials prior to being approved for regular use.
“Without clinical trials, you wouldn’t be able to take aspirin or other medications,” Baga says. “You also wouldn’t be able to receive regular cancer screenings or preventive vaccines.”
Clinical trials also may be conducted to see if standard-of-care treatments can be improved.
Because clinical trials evaluate medications, devices, screenings and vaccines before they are available to the general public, one benefit of participating is having early access to potentially new and successful treatments, screenings or preventive medications. This was the case for participants in the COVID-19 vaccine trials and cancer patients who participated in early trials for immunotherapy drugs (which were later approved and integrated into standard-of-care treatment plans for certain types of cancer).
“While this is a possibility, it’s important to know that not all trials lead to a breakthrough treatment, screening or vaccine,” Baga says. “As a participant, you won’t necessarily experience a significant health benefit from the trial. However, you will be followed closely by a team of clinicians involved with the research, so you will have an added layer of medical support. If you experience any health concerns, even if they aren’t related to the trial, that team will determine your next steps for care and help you connect with other clinicians.”
Future patients benefit most from clinical trials, as the information obtained from studies often leads to improved preventive care, screening and treatment guidelines later on.
“Participating in a clinical trial has never been safer,” Baga says. “There are many safety guidelines in place for research studies that take place in the United States, and many of these originated from the National Research Act of 1974.”
Before a drug, vaccine, screening method or device can be studied in clinical trials, the research must be proposed to the Food and Drug Administration (FDA). Once the FDA approves, the drug, vaccine, screening method or device will undergo preclinical testing, which does not involve humans. Once a certain level of safety has been proven by preclinical testing, it will go through various phases of the clinical trial process.
“Throughout all of the phases, participant safety is the No. 1 focus,” Baga says.
Organizations that offer research studies follow strict protocols as well.
“All institutions that offer clinical trials are required to have an institutional review board or an ethics committee that reviews all studies to make sure the risk–benefit ratio is acceptable for patients,” Baga says. “If the risks outweigh the benefits, the board or committee will not approve the trial.”
Baga and her colleagues hear many myths associated with clinical trials, including:
Myth: Clinical trials are only for people with no other treatment options.
Fact: While this is sometimes true, it isn’t the case for all clinical trials. Some studies evaluate new preventive drugs or screening guidelines, and others look to improve existing standard-of-care treatment regimens. The bottom line is, there’s a spectrum of clinical trials for all types of individuals, not just those who have tried all currently approved treatments for their condition.
Myth: Once I enroll in a clinical trial, I can’t leave without financial or medical consequences.
Fact: Participants can withdraw from clinical trials whenever they would like to and for whatever reason. There is no financial consequence, and they are still able to receive medical care at the institution hosting the trial.
Myth: If I’m enrolled in a treatment trial, I might get the placebo and not receive any care.
Fact: Clinical trials evaluating a new treatment option may have a placebo arm (meaning that certain participants will not receive the active treatment and instead will receive a sham or nonactive treatment), but this is only the case for conditions that don’t have any other approved treatment options.
If there is an approved therapy available, some participants may receive that instead of the treatment being investigated.
“If you are facing a medical condition and you are interested in learning more about available clinical trials, start by talking to your care team,” Baga says. “They will be happy to discuss the pros and cons with you, and they will also inform you of other treatment options you are eligible for.”
LVHN has been offering clinical trials for almost 40 years, and at any given time, we offer hundreds of research studies. These trials are overseen by NORI, the network’s full-service research office which is made up of various clinical and administrative professionals who work collaboratively to support research participants.
