Clinical trials are carefully controlled research studies conducted by doctors and other healthcare professionals with the goal of improving care and quality of life for patients with cancer.1,2 Advances in the diagnosis, treatment, and supportive care of patients with cancer, including chronic lymphocytic leukemia (CLL), depend on clinical trials.2
Reviewers at the US Food and Drug Administration (FDA) use clinical trial data to ensure that any new treatment meets one or both of the following criteria:
- The new medication or combination of medications is more effective—it extends survival and/or improves quality of life—compared with standard treatment.
- The new medication or combination of medications has fewer side effects than standard treatment.2
Most clinical trials of drugs used in the treatment of cancer are funded (sponsored) by government agencies, such as the National Cancer Institute, and nonprofit organizations, such as the Leukemia & Lymphoma Society (LLS), university-based (academic) medical centers, and pharmaceutical companies.2,3 When considering clinical trial participation, patients and families should know the sponsoring organization, as well as which costs associated with the trial will be paid by the sponsor and the patient’s insurance company.2
People of any age and cancer type can participate in clinical trials. Each trial has specific goals and entry (eligibility) criteria, such as type and stage of cancer; the patient’s age, gender, and race; and previous treatments received.2 For example, clinical trials may be specifically looking for patients who2:
- Have already tried standard treatment(s) for their cancer
- Have not yet had any treatment
- Do not have other medical conditions, such as liver or kidney disease.
Healthcare providers may inform their patients about opportunities to participate in a clinical trial, but patients who want to know more about joining a specific clinical trial may want to ask their care providers about it. When discussing clinical trial options, patients are likely to be introduced to a clinical trial team—doctors, nurses, social workers, and other healthcare professionals—that is responsible for the safe and accurate completion of the trial. These clinicians are responsible for:
- Checking each participant's health at the beginning of the trial
- Sharing specific instructions for taking part in the trial
- Monitoring each participant’s health throughout the trial
- In some cases, following up with patients after the trial is over.
A patient’s oncologist and other healthcare providers will coordinate with the clinical trial team to ensure that other ongoing treatments do not interfere with the study treatment.2
To learn more about clinical trial opportunities, patients are encouraged to read the referenced articles, as well as visit the clinical trial website maintained by the National Institutes of Health.1-3 In addition, www.ClinicalTrials.gov is a searchable database of privately and publicly funded clinical trials that are being conducted around the world. It provides details about ongoing trials, including the cities in which the research is being conducted, to help patients learn whether participating cancer centers are near their home.
References
- National Institutes of Health. Why should I participate in a clinical trial? May 30, 2019. www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial. Accessed April 2, 2020.
- Leukemia & Lymphoma Society. Clinical trials. www.lls.org/treatment/types-of-treatment/clinical-trials. Accessed April 1, 2020.
- National Institutes of Health. Learn about clinical studies. https://clinicaltrials.gov/ct2/about-studies/learn. Accessed April 10, 2020.
