Clinical Trials Frequently Asked Questions

With the goal of helping patients live healthier and longer lives, Main Line Health's scientists and physicians conduct clinical trials that involve participants who are willing to help advance medicine into new frontiers. This partnership between participants and researchers can lead to a better understanding of how to diagnose, treat, and prevent certain diseases or conditions.

During a clinical trial, researchers are trying to determine, for example, how new medications, detection or diagnostic tools, or devices work in humans. When you participate in a clinical trial, you may:

• Gain access to potential new treatments for a disease or condition
• Take advantage of an innovative health care choice
• Advance medical knowledge
• Help others who may develop or have a similar disease or condition

The ideas and therapies developed in clinical research often result in significant advances in science and medicine. Indeed, many treatments that are now standards of care were first proven to be effective in clinical trials. And when there are already-approved treatments for a particular cancer, a clinical trial may provide you the opportunity to get a treatment that we hope may be better than the available standard, often by comparing a new approach to that standard.

When no standard treatment is available, clinical trials offer you the chance to get a potentially effective therapy in a setting where no therapeutic has so far proven to be beneficial. Even if the therapy proves ineffective, the information obtained in a carefully done trial will help future patients.

Perhaps most importantly, participants in clinical trials gain access to the highest level of care and monitoring possible. Indeed, hospitals that conduct research are known to have the best patient outcomes.*

Lastly, all patients treated on clinical trials are followed very carefully by Main Line Health's clinical trials staff, in addition to the patient's care team. So you gain an extra layer of care and the satisfaction of knowing you're helping clinicians learn how best to treat future patients.

_{* Majumdar, SR, Roe, MT, Peterson, ED, et al. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med. 2008;168(6):657-662).}

Observational study — A type of study in which no formal treatment intervention takes place. Instead, participants are observed and/or certain outcomes are measured. No attempt is made by the researcher to affect the outcome—for example, no treatment is given by the researcher.

Clinical trial (interventional study) — During these types of clinical trials, researchers learn if a new test or treatment is safe and effective. Treatments studied in these clinical trials may be new drugs or new combinations of drugs; new surgical procedures or medical devices; or new ways to use existing treatments.

Medical records research — This type of research involves only the use of information collected from patient medical records. This is research done with the highest regard for patient privacy and usually requires anonymity. By studying the medical records of large groups of people over long periods of time, researchers can see how diseases progress and which treatments, interventions and surgical procedures work best for certain patient populations.

Adaptive trial — This type of study is flexible and allows modifications after the trial has started without undermining its validity or integrity. Researchers have an opportunity to change one or more specified aspects of the study design and hypothesis based on data analysis from participants in the study.

These terms refer to patient criteria such as age, gender, the type and stage of disease, previous treatment history, if any, and other medical conditions. To standardize the test results, each clinical trial is designed to have guidelines about participant criteria. While not everyone is a candidate to participate in a study, you should check with your health care provider to see if a study is available for your condition.

Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

The act of setting inclusion and exclusion criteria is not meant to reject people from a study, but rather to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the specific questions they seek to answer.

All studies have checks and balances for research to be done properly and for the results to be reported with a high degree of confidence. For example, oftentimes a control group of people provides the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group (who may have the same condition) is given the currently standard treatment for that illness.

When you learn as much as you can about a clinical trial and decide to participate, you are giving consent to be studied. The Main Line Health clinical trials team will ensure you understand the requirements of the protocol, as well as have a clear awareness of the potential benefits and risks of participation. The research study team will provide you with a consent document that includes details about the study: its purpose, duration, required procedures and key contacts.

Note that a consent form is not a contract, and you are free to withdraw from a trial at any time and for any reason. Withdrawal will have no effect on your current or future medical care at Main Line Health, or your current or future relationship with your physician.

Yes. Each type of trial must follow specific guidelines to ensure patient safety and privacy.

Every clinical trial conducted in the United States must be approved and monitored by an institutional review board (IRB) to ensure the risks to participants are kept at an absolute minimum. An IRB is an independent committee of physicians, statisticians, community advocates and others who make sure a clinical trial is ethical and patients' rights are protected.

Clinical trials follow detailed rules called protocols that explain exactly how researchers must conduct the trial, including the criteria for participation, schedule of procedures and treatments, and the length of the study. As the trial progresses, researchers often report the results to a number of government agencies and to other key people within the medical community. This would include any safety issues that arose during the course of the study.

While participating in a clinical trial, patients are under the close supervision of a team of experts and are closely monitored for any positive or negative reaction.

Before joining a research study, we encourage you to learn more about your rights as a research participant and the risks and benefits of being in research. Learn more by visiting the Main Line Health website for the Office of Research Protection.

No. Clinical trials are not intended to replace all ongoing treatment with a primary physician. Most clinical trials provide short-term treatments related to a specific illness or condition. They do not provide extended or complete primary health care. Your health care provider will work with the research team to help ensure that the trial protocol is safe and compatible with your other medications or treatments.

Clinical studies are available across Main Line Health, which comprises Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital, Riddle Hospital and Bryn Mawr Rehabilitation Hospital. Not every trial, however, is offered at every Main Line Health facility. Our clinical trials coordinators can direct you to the site at which a particular trial that would suit your specific needs is offered.

At any given time, various clinical trials are taking place within Main Line Health.

• The Center for Clinical Cardiology conducts studies on heart disease.
• The Center for Clinical Cancer Research conducts oncology studies.
• LIMR's Clinical Research Center conducts studies on other disorders.

For cancer clinical trials, contact cancertrials@mlhs.org or call 484.476.2649.

For cardiovascular clinical trials, contact Ann Marie Chikowski, MBA, RN, CCRC, division manager of cardiovascular research, at chikowskia@mlhs.org, or cardiologytrials@mlhs.org, or call 484.476.3030.

For other types of clinical trials, contact John Wellenbach at wellenbachj@mlhs.org, or call 484.476.3545.