What is the best way to test a new treatment or vaccine? The answer is usually clinical trials — a form of medical research that allows doctors to safely and effectively study specific health issues or test new medications, devices, therapies, drugs combinations, and dosages.
Clinical trials are used to help improve quality of life for people who are experiencing both acute and chronic illnesses. Physicians conduct these studies with the help of volunteer participants.
“Clinical research allows us to test new methods and treatments, and determine whether they are both safe and effective,” explains Summit Health Medical Director of Oncology Research Steven Papish, MD. “If you look at the history of cancer treatment, for example, we used to throw everything at patients from surgery to radiation and chemo. Over the years, however, clinical research has allowed us to identify magic bullets that tailored our therapies to individual cancers and patients.”
In general, clinical research helps determine whether:
- A new medication, device, treatment, or dose is safe and effective for a specific type of patient.
- An already marketed medication or device can be used for a different disease or condition than the one for which it was originally intended.
- A new medication, device, or treatment is more effective than the previous ones for a disease or condition.
Every clinical trial includes a panel of experts, known as physician investigators, who decide how to best use the new treatment. The investigators identify the types of patients who they think are most likely to benefit from the therapy. This team closely monitors each patient’s progress every step of the way.
“Many patients who have participated in research trials report having rewarding experiences,” says Dr. Gary Pien, Chair of Medical Research at Summit Health. “They feel extremely proud to be contributing to medical knowledge that will help future generations, and it truly is their participation that creates hope for better treatments and cures.”
Research Studies and COVID-19
Clinical trials have been front and center in the media throughout the pandemic. Over the past year, the public has seen firsthand how clinical research unfolds through the eyes of the COVID-19 vaccine program.
“COVID-19 vaccines are a good example of how we can use clinical research to test a new treatment and then bring it to the public so we can use it safely and effectively,” adds Dr. Papish. “Those 30,000 people in the COVID-19 vaccine trials are heroes—they are the reason we have vaccines available to the masses today.”
Phases of Clinical Trials
Clinical research is a structured process that involves several phases to ensure the safety of the participants and gain essential information.
Any new intervention is studied in several phases. These steps include:
- Phase I - Tests the safety of a new medication or device in a small number of volunteers.
- Phase II - Studies the efficacy of the therapy for its intended use.
- Phase III - Evaluates the potential drug or combination against the current standard of treatment in a large population of participants.
Study Volunteers Make a Difference
Research participants are the cornerstone of clinical trials. Without them, new medications would never be developed. Many participants join research studies because the current standard of treatment is not effective or tolerated well. Others simply want to advance science.
“Patients are the heart and soul of clinical research,” says Michelle Mackenzie, RN, OCN, CRC, Manager of Clinical Research at Summit Health. “I want study volunteers to know that they are not guinea pigs. Participants who test these state-of-the-art treatments are being monitored closely by everyone involved, including physicians, study coordinators, sponsors, and the Food and Drug Administration (FDA).
Safety is the number one priority in any clinical trial. Before a clinical trial can begin, the FDA and an Institutional Research Board (IRB) must approve the study. The IRB ensures that the trial is being conducted in a manner that best protects patient safety. Many participants feel even more protected on a clinical trial because of this extensive monitoring.
During a study, researchers monitor and record any changes the participants may experience as a result of the new intervention. Many trials randomly assign certain patients to receive placebos—pills or injections that do not contain medicine. Comparing patients who received the treatment with patients who did not, helps researchers test if the potential new intervention works.
The data is then used to make decisions about whether or not to use the medication, device, or treatment in a wide range of patients. Participants are also followed after the new therapy is finished. This allows researchers to identify any long-term symptoms or effects from the intervention.
Clinical Trials at Summit Health
Numerous drugs are now available to patients because Summit Health participated in clinical trials. Throughout the medical group’s history, patients have been involved in more than 350 clinical trials. The goal of the Office for Research is to have two percent of patients involved in clinical research at any given time. Learn more about our active clinical trials.
Some of the most notable drugs Summit Health has contributed to studying include:
- Verzenio – a targeted treatment used to treat certain types of metastatic breast cancer.
- KEYTRUDA – an immunotherapy for lung, skin, head and neck, as well as advanced kidney and bladder cancers.
Clinical trials allow patients to have access to potential new drugs before they are available on the market. “A clinical trial isn’t always going to show better results, but it is because of this research that we are eventually able to find the best treatment for each disease and patient,” explains Dr. Papish.
Oncologists and other specialty physicians work with patients to determine if they are eligible for clinical trials. Each trial has specific criteria including the volunteer’s age, type and stage of cancer, along with whether or not they have been treated with certain drugs in the past.
For more information about:
Oncology Trials – Contact Michelle Mackenzie, RN, OCN, CRC at 973-436-1755 or firstname.lastname@example.org.
For All Other Studies — Contact Kelly Ritter, LPN, CCRC at 908-721-5673 or email@example.com.