Clinical Trials: A Pathway to Treatment

Written by

Pierluigi Porcu, MD, Sidney Kimmel Cancer Center, Jefferson University Hospitals (At time of Publication: Associate Professor of Internal Medicine, Division of Hematology, Ohio State University Comprehensive Cancer Center)

Clinical trials can offer a promising treatment option

Clinical trials can offer a promising treatment option for people living with cutaneous lymphoma, especially when a patient finds their disease is unresponsive to therapies that are currently approved by the Food and Drug Administration (FDA).

Clinical trials are research studies that investigate new or experimental treatments in patients living with a specific disease.1  

These studies are not only important because they contribute to the overall knowledge and progress in understanding diseases such as cutaneous lymphoma, but they also play an instrumental role in the development and FDA approval of new therapies. Most importantly, a patient may benefit from an investigational treatment they are receiving as part of a clinical trial – they may experience a complete response, see improvement in their quality of life or find relief from symptoms. To continue expanding the treatment landscape for cutaneous lymphoma and potentially make a difference in the lives of patients, it’s imperative that individuals living with cutaneous lymphoma participate in clinical trials1.

For illustrative purposes only.
Clinical Trial Phases

There are various types of clinical trials including treatment trials that test experimental therapies or combinations of drugs; prevention trials that look for better ways to prevent disease and/or disease reoccurrence; diagnostic trials that identify better tests for diagnosing a disease; screening trials that work to detect disease; and quality of life trials that aim to improve comfort for individuals with a chronic illness.2 Regardless of the type, all clinical trials follow a defined protocol and are divided into phases:

  • Phase I involves a small group of subjects that are initially tested to determine the best method for administering the drug and the appropriate dosage amount;
  • Phase II works with a slightly larger group of patients to test the efficacy or effectiveness of the drug;
  • Phase III is an even larger group that usually involves comparing the new treatment to a traditional or current standard treatment;
  • If the results from phase III are favorable for the new drug, the results of the trial may be presented to the FDA for approval of the treatment; and
  • Phase IV, or post marketing studies, assess information such as the drug’s risks, benefits and optimal use.
When Should I Consider a Clinical Trial?

EXPERT PRESENTERS

Larisa Geskin, MD, Director, Cutaneous Oncology, Columbia University Medical Center (At time of publication: Associate Professor of Dermatology, University of Pittsburgh)

Stuart Lessin, MD, Medical Directory, KGL Skin Study Center

Pierluigi Porcu, MD, Director, Hematologic Malignancies and Hematopoietic Stem Cell Transplantation Division, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital (At time of publication: Associate Professor of Internal Medicine, Division of Hematology-Oncology, Ohio State University Comprehensive Cancer Center)

Marianne Tawa, RN, MSN, ANP, Nurse Practitioner, Dermatology and Cutaneous Oncology, Dana Farber Cancer Institute

Questions to Ask 

If you are interested in participating in a clinical trial, the decision is one that can be made with your physician and the help of a support network. Since your doctor knows your health history, he can assist you in locating a trial and answer any questions you may have.

A few questions to ask your doctor might include:

  • What are the potential benefits and risks of the study?
  • What side effects may occur?
  • May I continue with my current treatment regimen for CTCL?
  • In what ways will I be limited in my daily life as a result of the study?
  • If I withdraw, will it affect my normal care?
Finding a Trial

In addition to asking your doctor, online resources such as www.ClinicalTrials.gov,  www.nci.gov and the Cutaneous Lymphoma Foundation’s website can help you find current cutaneous lymphoma clinical trials. These sites provide information about both federally and privately supported clinical trials available in your area and they also include contacts and methods to request more information on a specific study.

Once you and your doctor have identified a cutaneous lymphoma trial that’s right for you, the trial’s team of doctors and nurses will explain the study protocol, and you will learn about trial details through an “informed consent” document prior to enrolling, which outlines the trial’s purpose, duration, required procedures, key contacts and risks as well as potential benefits. If you agree to join the trial, you will be asked to review and sign the informed consent document. Additionally, many trials require a medical screening beforehand to ensure that you meet the study’s health requirements.

Participating in a Clinical Trial

Over the course of the trial, you will be working closely with the trial’s team of doctors, nurses and researchers. Do not hesitate to ask them any questions you may have or raise concerns. Additionally, you may wish to bring a friend or relative with you for support. It is also important to ask if the study is covered by insurance, and to find out in advance what costs will be covered as health insurance and managed care providers do not always cover all patient costs depending on your individual plan.

Like any study, clinical trials do pose potential risks, which should be discussed in detail with your physician.

However, the potential benefits can be long-lasting and life-changing. Clinical trials empower patients to play an active role in their own care and open them up to access new treatments before they are widely available. During the course of the trial, patients will often receive care at leading health care facilities and be under the supervision of expert physicians within the cutaneous lymphoma field.

Ultimately, participation in clinical trials helps all cutaneous lymphoma patients by contributing and potentially furthering medical research.

 

(1) “Should You Join A Clinical Trial?” US Oncology Website.  Accessed on August 31, 2011.

(2) “Understanding Clinical Trials” Clinical Trials Website. Available at: http://clinicaltrials.gov/ct2/info/understand#Q18. Accessed on August 31, 2011.

What you should know about clinical trials: A Nurse's Perspective

EXPERT PRESENTER

Marianne C. Tawa, RN, MSN, ANP, Nurse Practitioner Dermatology & Cutaneous Oncology, Dana Farber Cancer Institute

Learn More

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Since the development of the “scientific method,” people have been engaged in research in efforts to answer questions, solve problems, and add to our overall knowledge. Nowhere is this more evident than in the medical field, and in the study of cutaneous lymphoma.

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