Health Break | Published August 2, 2010

Making the Case About Clinical Trials

Did you know that Mount Nittany Medical Center is part of the Penn State Hershey Cancer Institute? Patients are diagnosed with cancer, seen by their Oncologist and then referred to our department for consideration of a protocol, enrolled and treated here. We have many protocols open to meet our patient’s cancer diagnosis.The process begins when we talk with a cancer patient about a protocol for their treatment. We start with the basics! There are so many misconceptions about the words protocol, clinical research, clinical trials or studies that it is important to describe what the words mean and how the process works. Clinical trials are health-related research studies in human beings that follow a predefined set of rules. These rules protect the participants and ensure the integrity of the findings. A common myth is that clinical trials are dangerous. The truth is that patients on clinical trials are watched very closely by their doctors and care team. In fact, many patients have said they appreciated the extra attention they received while participating in a clinical trial. Trials are carefully monitored by the cooperative group, pharmaceutical company, or federal agency sponsoring the trial as well as, in most cases, an independent data and safety monitoring board. Patient data, without individual identifiers, is reported and shared among the sponsors. The local ethics committee or Institutional Review Board ensures that a clinical trial is ethical and that the rights of study participants are protected As part of the monitoring and data-sharing process, clinical researchers identify any irregularities in symptoms or side effects. If an unusual problem develops, the trial can be altered or stopped. A patient may opt out at any time for any reason. Just like all medical treatments, cancer clinical trials are not risk-free. However, the safety of patients is of utmost importance to the researchers.
Patients who participate in our clinical trials are given the best treatment available right here at home. They either receive the current standard of care or the chance to receive a new treatment being considered. The data and outcomes are compared to determine if the new treatment being evaluated is, indeed, better than the current best standard of care. If so the result is proof positive - and that new best standard will become available to other patients. Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Patients go through a process of learning the key facts about the trial before deciding whether or not to participate. Many research centers may be involved in the study, and each uses the same protocols to ensure that data from all centers can be combined and compared.
Each protocol defines specific characteristics, called eligibility criteria that participants need to have in order to participate in the study. Characteristics may include type of disease and its stage, as well as the participant’s age and general health. Eligibility criteria help assure that the study results answer the research questions and identify who will benefit in the future from the approach being studied. The patient needs to understand this information before deciding whether to participate in the treatment. We are fortunate to have the most up to date cancer treatments available to us at Mount Nittany Medical Center. It is a privilege for me to work with the phenomenal patients that I have met and treated. For more information about clinical trials or cancer, visit Barbara Gutch, RN, OCN, is a clinical research coordinator for Penn State Hershey Cancer Institute at Mount Nittany Medical Center