Here at Preferred Clinical Research, we strive to provide cutting-edge clinical research to our community. In order to provide the best care for our patients, we want to offer more information as to what clinical research studies are, how they can help you, and where to go for more information. If you have any any questions, please do not hesitate to contact us.
What is a Clinical Trial?
Clinical trials, or clinical studies, are designed to add to medical knowledge by testing treatments or potential treatments in human volunteers. The treatment may be a drug, a vaccine, a device, a blood product, gene therapy, or behavior modification. Investigators (the study physicians) are trying to determine if the new product or approach is helpful, harmful, or no different from the current therapies. Clinical trials are required by all regulatory agencies (e.g. The Food and Drug Administration) before a new product can be brought to market.
Who Conducts Clinical Trials?
Clinical studies can be funded or sponsored by pharmaceutical companies, federal agencies, academic medical centers, or other organizations. In addition, health care providers or other individuals can also sponsor clinical research.
Each study is led by a principal investigator and may be supported by a research team that can include doctors, nurses, pharmacists, regulatory personnel, and other health care professionals.
Who Can Participate in a Clinical Study?
Clinical studies have specific standards regarding who may participate. These standards are known as eligibility criteria. Some studies seek participants who have certain illnesses or conditions where others look for healthy participants.
- Eligibility – Inclusion criteria are the factors that allow a person to participate in a trial and exclusion criteria are factors that my disqualify participation. These are based on things such as age, race, sex, type of disease, stage of disease, and other medical conditions
Considerations for Participation
The results of studies can make a difference in the care of future patients. Clinical trials also provide the basis for the development and marketing of new drugs, medical products, and devices. Some trials may provide the prospect of receiving direct medical benefits while others do not. Most trials involve some risk of harm or injury although it may not be any greater than the risks related to routine medical treatment or disease progression. Many trials require additional tests, procedures, and assessments based on the study protocol. The risks of participation have been minimized and are considered reasonable in relation to anticipated benefits. All of the risks and potential benefits will be described in the informed consent document for each trial. A potential study participant should also discuss these issues with the members of the research team, family members, and with his or her usual health care provider.
Where Can I Go to Learn More?
To learn more about clinical research, visit CISCRP (The Center for Information & Study on Clinical Research Participation).
To learn more about clinical studies going on at Preferred Clinical Research, please visit us at one of our five locations in southwestern Pennsylvania, to let us know what diseases you are interested in. We’ll then notify you when a study becomes available.