Clinical Research
What is Clinical Research?
Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.
All medicines and treatments have to be researched for many years and FDA approved before doctors can prescribe them. Volunteers are a very important to this process. Without volunteers, we could not conduct these trials.
The more a drug shows positive signs, the more participants will be added to the trial and the research continues to the next phase. Clinical trials can vary in size from a single center in one country to multi-center trials in multiple countries.
Drug, device, and procedure testing begins with extensive laboratory research which can involve years of experiments. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. Once approved, human testing of experimental drugs, devices and procedures can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after each phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
Clinical Trial Phases
Phase I studies assess the safety of a drug, device or procedure. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers. The study is designed to determine the effects of the drug, device or procedure on humans including how it is absorbed, metabolized, and excreted. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the effectiveness of a drug, device or procedure. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About 33% of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III studies involve several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug, device or procedure, the benefits and the range of possible side effects. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
Who Should Participate?
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.
Some people participate in clinical trials because they have exhausted approved treatment options - which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.
Other people participate in trials because they want to contribute to the advancement of medical knowledge. Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a medication.
Why Should I Participate?
• All visits, tests, and procedures related to the study are free of charge.
• You will be compensated for your time.
• Health insurance is not required to participate.
• You have access to the latest medications and treatments that are not otherwise available.
• You may benefit your future and the future of others by helping doctors evaluate new medications.
Is Research for Me?
Clinical Research trials provide people with the chance to improve the quality of their lives, as well as contribute to the discovery of new and improved medications. To be eligible to participate, you must meet the requirements of a particular trial. Each study has different requirements. After speaking to one of our patient specialist, you would know if you fit the criteria or not. For a list of our current studies, visit our website.
For more detailed information and answers to frequently asked questions about participating in clinical trials, view our FAQ Page or call us today at 407-426-9299.
