Clinical Trials - Understanding the Process

Created with content provided by Jessica Severt, RN, BSN, Clinical Research Nurse Coordinator at Thompson Cancer Survival Center

Have you ever wondered how patients are selected to participate in a clinical trial or how they know where to start? Maybe your doctor has mentioned the possibility of you or a loved one being in a study, but you are hesitant because you don’t know what to expect? Have you questioned whether a clinical trial is a good and safe fit for you? This blog describes the initial processes of joining a clinical trial. We hope the information empowers you and dispels any fears you may have of the unknown.

Clinical Research at Thompson

Perhaps your doctor has mentioned that one of the studies available here, at Thompson Cancer Survival Center, may be an option for you. Should you choose to explore the option, we have an experienced Clinical Research team that will be with you every step of the way. The study nurses keep you fully informed and are a resource for you during the consenting, screening, and on-study treatment processes.

Informed Consent

Many times a serious diagnosis causes patients or physicians to seek out clinical trial options. One way the process begins is when a physician discusses a potential study with a patient during one of their appointments. If that patient is interested in receiving more information about the study, one of our clinical research nurses will either call or meet with the patient on-site.

The clinical research nurse provides the patient with printed information about the study, including informed consent. These documents detail important information the patient needs to make the best decision. The study nurse and the patient review the documents and discuss the study details together. Before committing to joining the study, the patient has the opportunity to take the documents home to review with friends, family, or anyone who assists in their medical decisions.

If the patient is still interested in participating after reviewing the information, the research nurse sets up a follow-up phone call or another on-site visit to answer additional questions. When the patient is comfortable that they fully understand the information and want to move forward, then the patient will sign the consent. The patient will receive a signed copy of this consent form, which includes a patient calendar. This calendar details what the patient can expect at each clinic visit. Once the consent is signed this will start the screening process.

Screening

The screening process is the second phase of beginning a clinical trial. During the screening process, labs (bloodwork) will be drawn, additional radiologic imaging may be obtained, and other initial testing will be completed. These things are completed to confirm that it is safe for the patient to continue to the treatment portion of the clinical trial. Preliminary screenings can typically take anywhere from 1-3 weeks.

Each clinical trial has established a strict and standardized set of guidelines a patient must meet to qualify for participation. These guidelines are in place to ensure patient safety. The defined parameters usually include ranges within which screening results must fall. As these screening tests are reviewed, it is possible that the results are out of the accepted range for the study. If this happens, the patient will not proceed to the treatment phase. If however, all of the screening results fall within the acceptable guidelines, the patient then moves forward to the next phase: treatment.

On-Study Treatment

The next phase of the study begins with planning the patient’s treatment visit. The study nurse stays in constant contact with the patient and their doctor to ensure everyone has all the needed information. The study nurse remains a constant resource for the patient and the medical team for all study-related questions or concerns.

Throughout the treatment, the patient is closely monitored and assessed by their physician and the study nurse to ensure safety and to intervene early if needed. The study nurse attends all of the patient’s doctor appointments and may contact the patient between visits just to check-in. The study nurse encourages the patient to reach out if they ever have concerns, issues, questions, or simply need some reassurance!

The More You Know

Patients are able to explore the clinical trials available in our local area and abroad by visiting www.clinicaltrials.gov.

Clinical trials allow patients access to treatments that are not available outside of the study and patients are closely monitored while on-study. Our Clinical Research team here at Thompson encourages each patient to explore clinical trial options, ask their physician questions, and use the information they find to take an active role in their own healthcare.

Visit Thompson Cancer Survival Center’s Clinical Research page to learn more about clinical trials and our fantastic team.

Learn more about Clinical Trials in the blog: 7 Myths about Clinical Trials Dispelled.