Clinical Trials: Knowing Your Options

By Allison Mowatt

When it comes to our health and well-being, complete knowledge, awareness, trust, communication, and understanding are essential in obtaining and achieving an optimum constitution.  When faced with any medical condition or illness, it is important to know all the treatment options available.

Standard treatments may not always work for a given condition, and doctors, nurses, therapists, and other health care professionals are constantly immersed in research to seek additional treatments that are beneficial and cutting edge.  Many facilities and institutions offer clinical trials, which are studies using human volunteers that follow a pre-defined protocol in the hopes of answering specific health questions.  Clinical trials are offered for a wide range of conditions from cancer to depression allowing researchers to study the effectiveness of everything from chemotherapy to antibiotics.  Locally, clinical trials are often offered in oncology, cardiology, and for treatment of depression.  The largest group of trials conducted in our area is in the radiation and medical oncology fields.

“These trials are another way the medical community learns whether a particular treatment (medication, counseling, exercise, etc) is safe and effective,” said Dr. Janet Townsend, Professor and Founding Chair of the Department of Family, Community and Rural Health at The Commonwealth Medical College (TCMC) in Scranton.  Educating people about the benefits of clinical trials will enhance their knowledge about what new treatments and medical advances are available.  Increased awareness helps reduce fears about the unknown.

“Clinical trials are essential to our ability to improve care for our patients in all categories of illness,” said Dr. Samuel Lesko, Medical and Research Director at the Northeast Regional Cancer Institute in Scranton.  “It is a very valuable tool that helps us understand what new treatments do and do not work.  For example, there is a good track record in pediatric oncology because of parents’ willingness to enroll their children in clinical trials, and survival rates in children with cancer have increased dramatically as a result.”  The Northeast Regional Cancer Institute is a non-profit organization working to ease the burden of cancer in Northeastern Pennsylvania.

There are different types of clinical trials, and they are conducted in phases.  The trials at each phase have a different purpose and help scientists answer different questions.  For example, treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy while prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning.

The phases outline the trial’s progression.  For instance, during Phase One, researchers test an experimental drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.  During Phase 2, the experimental study drug or treatment is given to a larger group of people to see if it is effective and further evaluate its safety.  In the third phase, the experimental study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.  In Phase 4, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Studies determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.  Research subjects are assigned by the investigator to a treatment or other intervention and their outcomes are measured.  Clinical trials also address health issues in large groups of people or populations in natural settings and volunteers are observed and outcomes are studied.  “Once a clinical trial is completed and a treatment deemed safe, then it’s released to the larger population,” said Dr. Townsend.

People find clinical trials appealing because they can take an active role in their own health care, gain access to new research treatments before they are widely available, obtain expert medical care at leading health care facilities during the trial, and help others by contributing to medical research.  During a trial, medical professionals check the person’s health at the beginning, give specific instructions for participation, monitor the individual carefully throughout, and stay in touch after completion.

Of course, participants are not able to decide for themselves if they’re a good candidate for a clinical trial.  All trials have guidelines that are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.  A candidate must qualify for the study, which is essential in identifying appropriate participants, keeping them safe, and ensuring the researchers are able to answer the questions they plan to study.  In addition, some studies seek volunteers with illnesses or conditions while others need healthy participants.

Once a person is selected, they must be informed of all the key facts and details of the clinical trial before deciding if they want to participate.  They are asked to sign an informed consent document where all the potential benefits and risks are outlined.  Some possible risks these trials can impose include unpleasant, serious, or even life-threatening side effects to experimental treatment.  In addition, the treatment may not be effective for the participant.  The individual is allowed to withdraw from the trial at any time.

The benefits seem to outweigh the risks if participating in a clinical trial can help the world of medicine develop modern, effective, and safe treatments that could potentially save lives.

“I encourage anyone who is eligible to seriously consider participating,” said Dr. Lesko.  “Ask your physician about clinical trials and be aware of what’s out there.”

Background details for this article was based on information from www.clinicaltrials.gov. The website provides up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions.  It currently contains thousands of trials sponsored by the National Institutes of Health, other federal agencies, and private industry.

Local Medical Facilities That Run Clinical Trials and Research Groups

The Commonwealth Medical College (TCMC)- A medical school that serves all of northeastern and part of north central Pennsylvania.  The college educates aspiring physicians and scientists to serve society using a community-based, patient centered, inter-professional and evidence-based model of education that is committed to inclusion, promotes discovery, and utilizes innovative techniques.  TCMC features Core Research Facilities that provide access to state-of-the-art technology, offers a variety of services, provides training and assists in experimental design.  For more information, call (570) 504-7000 or visit www.thecommonwealthmedical.com.

*TCMC is in the process of completing its first clinical trial, the EAGeR study, which is a national trial studying the use of low dose aspirin versus a placebo.  It is a double-blind placebo controlled trial involving the recruitment of women who’ve had one or two miscarriages without previous fertility issues.  About 15 to 30 percent of women will have had a pregnancy that ended in an unexplained miscarriage.  Researchers are hoping to find answers through this study.  The trial attempts to determine if taking a low dose aspirin before and during pregnancy would prevent an early loss.  Since aspirin reduces blood clotting and inflammation, would it bring more blood flow to the uterus, resulting in a healthy pregnancy from the start?  Dr. Townsend and Betsy Mead, RN, BSN worked with about 80 women locally in Wayne, Lackawanna, and Luzerne Counties who participated in this study.  The trial started in 2008 and will close next month.  The results will then be analyzed, shared with participants, and announced to the medical community and general public through a publication in a medical journal.  For more information, visit www.eagertrial.org.

Hematology & Oncology Associates of Northeastern Pennsylvania, PC- Established in 1971, this office specializes in Hematology and Medical Oncology and provides quality care to patients in conjunction with the best technologies and medicines available.  The physicians provide care at two locations, in Dunmore, which is the primary facility on 1100 Meade Street, and the satellite office in Scranton at 5 Morgan Highway, Suite 8.  The physicians are actively involved with clinical research trials and consider all patients for these trials.  For more information, call (570) 342-3675 or visit www.hemonc1.com.

(NROC) Northeast Radiation Oncology Center – NROC offers a level of excellence in cancer treatment and cancer research.  With three sites in Dunmore, Scranton, and Milford, the most advanced radiation therapy options are available throughout the region.  Clinical research is an essential part of their mission, and everyday operations and various radiation trials are frequently offered. The staff is devoted to doing their best to make sure people know their options with a cancer diagnosis.  NROC provides care at 1110 Meade Street in Dunmore, 746 Jefferson Avenue in Scranton at Regional Hospital of Scranton, and 113 Pocono Drive in Milford at the Upper Delaware Valley Cancer Center.  For more information, call (570) 504-7200 or visit www.nrocdoctors.com.

*NROC’s Active Clinical Research Protocols:  An example of several active protocols include: BREAST RTOG: 1005- A randomized Phase 3 trial looking at shortening the treatments for select women with breast cancer.  The National Cancer Institute (NCI) is scientifically looking into ways to reduce the cost and inconvenience of cancer care—this is one such trial. GASTROINTESTINAL RTOG: 0436- A Phase 3 trial evaluating the addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for patients with Esophageal cancer who are treated without surgery.

HEAD AND NECK RTOG: 1016- A Phase 3 trial of radiotherapy plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx cancer.

“At NROC we put an emphasis on enrolling patients in NCI sponsored trials like you’d find in major cities, at no additional cost to the patient,” said Christopher A. Peters, M.D.  “When new patients are seen, members of a clinical research team on the physician level and research associate level are able to screen what trials are available for each patient, and our multi-modality conference group can list the pros and cons of any particular trials for that patient.  This not only increases the quality of care being given, but also facilitates speedier access to key health care providers, and in and of itself, provides intrinsic quality assurance when different members of a given specialty can weigh in on their opinions for each case.”  For more information about these and other trials, visit www.nrocdoctors.com/Research.htm.