It is the multi-stage process by which new medications are brought to market. This translates into a new medication being made available for prescription or over-the-counter sales. Clinical research trials on an individual drug are conducted in a step wise fashion, whereby information is collected and evaluated for safety and effectiveness in patients before the next step is undertaken. The entire process is a system of checks and balances where the drug company (development and funding), the research site (clinical medicine) and the human ethics committee (participant protection) work together on each study under the regulatory oversight of the US FDA. In other words, this is the research and development of medical products required by the US Food & Drug Administration. Any medicine that your doctor can write a prescription for or that you can obtain at a retail pharmacy has been though clinical research and received FDA approval prior to being made available to you.
Study participants, or volunteers, are individuals from the general public with the symptoms or medical diagnosis that a particular study intends to treat. Under FDA Regulations, a study participant must be thoroughly educated about the research program by way of a written description about the study. They must be given an opportunity to review all available information about the study and to ask questions before deciding whether or not they wish to participate.
Information Provided to a Potential Research Study Participant
The written information that will be presented to a potential research study candidate, as required by the FDA, must include a comprehensive description about the study drug, including the potential benefits and risks associated with the study, as well as notification of alternative treatments available besides the study. This regulatory requirement of obtaining written informed consent from a potential study participant is central to the regulatory and ethical guidelines for involving humans in biomedical research. In order to make an informed choice, as to whether or not a person wishes to participate in a clinical research study, they must first be given an opportunity to read and understand what they are committing to. Equally important, a study participant can always withdraw from study participation, for any reason, without any penalty or loss of benefit. However, it is always advisable to exit from study participation in the same orderly fashion as described in the enrollment process above.
Once You Agree to Participate in a Clinical Study
Once an individual decides that they want to take part in a clinical study, their health history is thoroughly reviewed and their current medical state is assessed to determine if they meet selection criteria for study enrollment. A patient that is enrolled into a study is followed under the direction of a licensed medical doctor for the duration of the study or until such time that they withdraw for personal or medical reasons. All studies vary in the type of participant being sought, the medical indication and timeframe. However, the regulatory and ethical requirements related to clinical research apply under every circumstance regardless if the study is for a nuisance symptom,
like athletes’ foot, or a life threatening condition such as cancer.
Provisions for Clinical Research Participants
Individuals who participate in clinical research with our clinic are provided with study-related clinic visits,
diagnostic tests and study treatment at no cost. In addition, study participants are paid a pre-determined amount of money for completing planned study visits. This payment is intended to reduce or eliminate any out-of-pocket costs associated with time and travel. Clinical research studies make no claim of benefit to a study participant, as in being able to relieve or cure a medical condition, but under no circumstances would a participant be continued in a study if it is not in their best interest from a medical perspective. If the condition under study does not improve, or even worsens, the participant would be discontinued and every effort would be made to facilitate a conventional treatment plan using currently available medications or therapies. Ultimately, any benefit an individual study participant derives is of their own determination, sort of like beauty being in the eye of the beholder. If the study medication relieves symptoms or improves one’s quality of life, that may be considered a benefit. If the no cost healthcare received by a study participant is of value to the individual, this too may be considered a benefit. However, any perceived or realized benefit from study participation is entirely subjective.