A clinical trial is a research study used to test the safety and effectiveness of a new investigational medication, medical treatment, devise or new ways of using known treatments in human volunteers. There are typically four phases in the process of testing, receiving approval and marketing and selling a new drug device.
Phase One: This phase/study focuses mainly on evaluating a drug's safety. A relatively small group of volunteers participate in this study to assist in determining what the drug does when it is in the body. It also assesses any side effects associated with the drug.
Phase Two: Involving a larger number of patient volunteers, this phase evaluates the effectiveness of the drug. There are usually two groups of patient volunteers in this study; one that receives the study drug, and another that receives a "placebo" or standard method of treatment. Both groups are then compared to each other to determine the study drug's effectiveness and safety.
Phase Three: This phase involves an even larger number of patient volunteers to further gather and evaluate important data regarding the study drug's possible side effects and effectiveness, usually referred to as "efficacy and safety". With some study drugs, this phase can last several years to complete. After successfully completing this phase of testing, a pharmaceutical company can make application to the federal government to market and make available for sale the drug.
Phase Four: This phase usually involves further evaluation of the study drug in a variety of ways. This could include the ongoing safety and efficacy in a larger patient population, compare the drug to other, similar drugs already in the marketplace for cost-effectiveness and similar benefit, and the overall long term effect of a patient's condition and quality of life.
Each clinical trial has specific guidelines as to who can participate. These guidelines are called inclusion/exclusion criteria and are typically based on factors such as age, sex, medical history, current medical conditions or current medications. After agreeing to be assessed for participation, you will undergo a very detailed screening process to determine your eligibility to participate in a study.
There are various benefits to participating in a clinical trial including health, personal and financial benefits. Study participants will receive medical care that they may not otherwise be able to afford. Additionally, many participants gain personal satisfaction from taking an active role in their health, while at the same time, helping others by contributing to the advancement of medical research.
Usually there is no cost to participate in a clinical trial. In fact, many studies offer study-related tests and medication to participants at no cost.
The FDA imposes strict guidelines and safe guards on all clinical trials to protect those who chose to participate. Each and every clinical trial must be approved and monitored by the Institutional Review Board or IRB. The IRB works to ensure that the risks are as low as possible.
The IRB or Institutional Review Board is a group of medical and non-medical professionals who are mandated to review and approve each clinical study before it begins. The IRB carefully reviews the activities of each study to ensure that the rights and safety of all subject participants are protected.
Occasionally, participants in clinical trials may experience side effects or adverse reactions to the study medications or treatments. Additionally, participants may find the treatment was not effective for them. Before each study, participants are warned of potential risks and must sign an informed consent form.
Informed consent is the process by which a potential study participant learns the facts about the trial before deciding whether or not to participate. Potential participants are provided information on why the study is being done, what is involved in the trial, the duration of the study, the length and frequency of the required office visits, and the know benefits and potential risks. Participants receive an informed consent document which they can review and ask questions prior to signing. After signing the document, participants receive a copy. An informed consent in no way obligates the individual to participate in the study. Participants may opt-out of a study at any time.
Clinical trials can be sponsored by pharmaceutical companies, government agencies and individual physician investigators. Studies usually take place in doctor’s offices, hospitals, universities or independent research facilities.
Innova Clinical Trials takes your privacy very seriously. We adhere to strict guidelines set forth by HIPAA.
Please fill out our Volunteers form to be added to our database for possible inclusion in an upcoming study.
Information on Clinical Trials and Human Research Studies: www.clinicaltrials.gov
US Food and Drug Administration: www.fda.gov
Pharmaceutical Research and Manufacturers of America: www.phrma.org
Institutional Review Boards: http://www.fda.gov/oc/ohrt/irbs/