Clinical Trials Education Center

Clinical trials for pulmonary fibrosis treatment are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials for pulmonary fibrosis treatment produce the best data available for health care decision making.

With studies currently in various stages of development, there are a variety of clinical trials that are actively seeking the participation of patients. Some of the therapeutic approaches currently being studied include:

• Anti-fibrotic therapies, which may slow or inhibit the production of scar tissue (fibrosis).
• Inhibitors of "growth factor" proteins, which block proteins that stimulate the lungs to make scar tissue.
• Stem cell therapies, which may help damaged lungs to heal.
• Genetic research, which identifies genes and genetic variants that may be associated with the development and progression of PF.

• Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured.
  

• Observational studies are those in which individuals are observed (no intervention in the study) and their outcomes are measured by the investigators.
  

• Expanded access studies are those in which the Food and Drug Administration (FDA) allows manufacturers to provide investigational new drugs (under certain circumstances), to patients with serious diseases or conditions who cannot participate in a clinical trial.

• Basic science studies are done to increase the fundamental understanding of the disease process on a molecular and cellular level. In the long term, this type of research can provide the scientific basis for the development of effective treatments.
  

• Epidemiological research studies a disease within certain populations; research in this area can lead to better understanding of potential risk factors, including occupational or environmental exposures that may lead to development of a disease.
  

• Translational research translates basic research findings into meaningful treatments and clinical applications. This research is becoming increasingly prominent and the National Institute of Health is proposing the creation of a National Center for Advancing Translational Sciences (NCATS).
  

• Clinical research studies are performed to determine the safety and efficacy of medications, treatment regiments, and diagnostic procedures. The different phases of clinical trials for the development of new therapies are described above.
  

• Quality of Life/Social Science studies are a subcategory of Clinical Research, which had been previously often ignored but has gained increased attention by the research community and the regulatory agencies. The term is used to refer to the general “well-being” of individuals undergoing specific treatment modalities, not only including medications but also supportive therapies (nutrition, exercise, respiratory therapy and psycho-social support).

The intervention is a process or action that is the focus of a clinical study, including drugs and medical devices.

• Oral Drug:  A drug taken through the mouth, typically in a tablet or capsule, but could also include liquids.
  

• Inhaled Drug:  A drug breathed directly into the lungs, most often through an aerosol device or nebulizer.
  

• Intravenous (IV) Injection:  A drug injected or infused directly into a vein via needle or tube, typically administered by a trained healthcare professional.
  

• Subcutaneous (SC) Injection:  A drug injected into the tissue layer under the skin via a short needle, typically in the side of the upper arm.