Clinical Research| Lancaster General Health

Clinical research gives you access to leading-edge methods of preventing, diagnosing, and treating diseases and conditions. At Penn Medicine Lancaster General Health, we have been helping people participate in clinical research and observational studies for more than 30 years.

We offer local opportunities to people in the Lancaster County community. We also offer the opportunity to participate in groundbreaking research at other Penn Medicine hospitals without having to travel to Philadelphia.

What Is Clinical Research?

Clinical research is the study of health and illness in people. There are two main types of clinical research:

Observational studies: Observational studies watch participants in their regular environment over time. These types of studies look at behavior and trends instead of testing an intervention (drug, device, or behavior). Observational studies can function on their own or serve as the first step in creating a clinical trial.
Clinical trials: Clinical trials are a type of clinical research that tests an intervention in human study participants. Clinical trials aim to answer important questions that could lead to improvements in care, treatments, and quality of life.

A randomized trial is one that randomly assigns treatments to participants. They could receive an active treatment, standard medical care, a placebo (an inactive treatment that has no effect on participants’ health), or a combination of treatments. Randomized trials are the gold standard for obtaining the best and most unbiased evidence to prove an intervention’s effectiveness.

Regulators require researchers to conduct clinical trials for all new investigational drugs and devices before they can be approved for widespread use. Treatments currently considered the standard of care were first tested by researchers as investigational products in clinical trials. Clinical trials couldn’t be successful without human participants. Learn what to expect during a research study.

Your participation helps researchers understand the safety, efficacy, and effectiveness of new:

Drugs
Devices
Lifestyle modifications
Prevention, diagnosis, and treatment methods
Procedures

How Clinical Research Works

Before researchers can do human testing, they must first test their idea in something that mimics how it might affect humans. Only the safest, most promising ideas then make it to the clinical trial stage.

The care method or investigational product then undergoes even more testing. For drugs, there are four clinical trial phases (I, II, III, and IV):

Phase I: This phase assesses a drug’s safety, side effects, and dosage among relatively healthy volunteers.
Phase II: This phase assesses the drug’s efficacy (whether it does what researchers think it will do) and side effects among a larger group of effected participants.
Phase III: This phase determines a drug’s long-term efficacy among a new, more diverse group of participants. It also compares the drug with other treatments. If a clinical trial reaches phase III, researchers are comfortable moving forward to assess efficacy in a larger sample of patients. Drugs are eligible for U.S. Food and Drug Administration (FDA) approval after successful completion of this phase.
Phase IV: During this phase, researchers continue to study the drug’s safety and effectiveness.

Types of Clinical Research Offered at the Penn Medicine Lancaster General Health Research Institute

We conduct clinical research in many areas of medicine, including:

Behavioral health
Cancer care
Cardiothoracic surgery
Diabetes and endocrinology
Family medicine
General surgery
Medical and device therapy for heart and vascular care
Nursing
Orthopaedic and musculoskeletal care
Pediatrics
Pulmonology (lung and respiratory care)
Trauma and acute care surgery
Vascular surgery
Women’s health

Find Clinical Research Studies at Penn Medicine Lancaster General Health

Learn more about our actively recruiting studies

See all Penn Medicine clinical studies

What Are the Benefits of Clinical Research?

There are many advantages to joining a research study, including:

Early access to the latest advances: Research participants are among the first to benefit from the latest medical breakthroughs.
Improved care: Research studies involve detailed care plans (protocols). As a result, you may have more frequent check-ups and other services you normally wouldn’t receive.
Free or low-cost health care: Most studies at Penn Medicine Lancaster General Health don’t involve added costs for you or your insurer. The study's sponsor usually covers costs that are specific to the study and not standard of care.
Making a difference: When you participate in research, you help providers learn better ways to prevent, treat, and care for people now and in the future. You can also help improve medical care for our community. Many of the studies at Penn Medicine Lancaster General Health focus on conditions that affect people in the Lancaster area, including heart disease, stroke, and diabetes.

Patient Safety in Clinical Studies

To keep research participants safe, federal, state, and organizational regulations and laws set the structure, goals, and activities of these groups:

Human Research Protection Program (HRPP): The Penn Medicine Lancaster General Health Human Research Protection Program includes the Lancaster General Hospital Institutional Review Board. Together, they ensure all research studies follow ethical, federal, state, and Research Institute standards and regulations for human research. Penn Medicine Lancaster General Health has maintained accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) since 2015. AAHRPP accreditation shows that our research exceeds standards established by regulatory organizations like the U.S. Food and Drug Administration (FDA).
Institutional Review Board (IRB): The IRB is made of more than a dozen representatives, including physicians, nurses, PhD scientists, and other nonmedical professionals. The primary purpose of the IRB is to protect the rights and welfare of research participants and monitor ongoing studies for safety and patient privacy concerns. Periodically, internal and external monitors inspect individual study records for compliance with the protocol and other safety standards.
Data and Safety Monitoring Boards (DSMBs): Studies that test specific devices, treatments, or procedures have their own independent Data and Safety Monitoring Board. DSMBs regularly meet to review study data and monitor protocol compliance and patient safety. They are sometimes called Data Monitoring Committees (DMCs).