Volunteer Study Subject
Thank you for visiting us. More than likely, you came upon our site because you are interested in clinical trials. If you are interested in being a participant in a clinical trial, we strongly encourage you to gain as much understanding as possible about participating. You can start by reviewing our about clinical trials information on this page. We have also included responses to some questions you may have as well as links to other resources where you can gather additional information.
Clinical Conduct Associates maintains a secured database of potential study participants. If you suffer from an illness or recurring condition and wish to see if any of Clinical Conduct associates Investigators are carrying out trials in your particular therapeutic area and would therefore wish to be considered for these trials, please complete and submit the volunteer data form. We take very seriously your privacy. Any information you provide to us is kept in the strictest of confidence and will only be used for the sole purpose of matching your clinical trial participation interests to present and future clinical trials. If you do not feel comfortable submitting your information online, you can always contact us to discuss your particular interests and provide us with the information we need to include you in our database.
About Clinical Trials
Before a pharmaceutical company can perform a clinical trial in humans, they must first complete very comprehensive research in the laboratory, on human cells, and animals. If, after this extensive effort, they wish to proceed, they must apply for, and receive, approval from agencies within the government. There are typically four (4) phases in the process of testing, receiving governmental approval, and marketing/selling of a new drug or medical 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. Approximately three out of four studies will pass this testing phase.
Phase Two: Involving a larger number of patient volunteers (usually up to several hundred), 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. About one out of three investigational drugs are successful in completing Phase One and Phase Two studies.
Phase Three: This phase involves an even larger number of patient volunteers (upwards of several thousand) 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. About nine out of ten drugs successfully complete this phase.
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.
Questions You May Be Asking Yourself
Why would I want to participate in a clinical trial?
You may wish to participate in a clinical trial for a variety of reasons. It can be a very rewarding and satisfying experience as well as providing you an opportunity to contribute to the development of new and "cutting edge" medical treatment. Study participants will usually receive close and comprehensive medical attention from highly skilled professionals who are readily available to answer any questions you have or if you experience any side effects. Many times you will receive diagnostic testing, examinations and treatment without charge, depending on the study. This can help offset expenses that otherwise would make it difficult for you to receive without insurance coverage.
What is it like to be a volunteer in a clinical trial?
Participation in a clinical investigation takes a commitment on your part as well as the physician and nurses working with you. They take your participation very seriously. You will make regular appointments to see your physician and receive a high level of personal attention. You will be given all the time necessary to answer all of your questions so you have a complete understanding of the study.
Some questions you may want to consider asking when discussing your possible participation in a study
- What is the purpose of the study? What does the pharmaceutical company hope to learn from the study?
- What is the length of time I am being asked to spend participating in the study?
- What are the potential side effects, risks and benefits to me?
- Are there alternative treatments available? If so, what are they?
- What kind of treatment/medication will I be given?
- What medical options are available to me should I be unable to complete the study?
Are my rights as a person/volunteer protected?
ABSOLUTELY. Aside from knowing that a study cannot begin without governmental approval, an independent group of professionals called an Ethics committee also must approve the study before it can be initiated by your physician. An Ethics committee is a group of medical and non-medical professionals whose primary responsibility is to review the study to make sure it poses no undue risks to the study participants. Your physician is also required to provide the Ethics committee with periodic reports while the study is being conducted. Additionally, your medical records are held in the strictest confidence. It is also important to know that you may terminate your participation at any time without jeopardizing your access to other medical treatment.
How do I know if I'm eligible to participate in a clinical trial?
Every study has a different purpose and a specific question it is trying to answer. In order to do that, very specific criteria, or requirements, are developed in order to evaluate an individual's ability to participate. After agreeing to be assessed for participation, you will undergo a very detailed screening process to determine your eligibility to participate in a study.
How can I be considered for a study? How do I find out about available studies?
There are many forums to identify ongoing clinical drug trials. You can ask your personal physician, your local medical centre, hospital, or University. There are many websites available as well that list clinical trials. You can also contact us to inquire as to what studies we are currently seeking volunteers for, as well as register with us for upcoming studies.