What is Clinical Research?
Clinical research is the scientific process of testing new medications or the combinations of existing medications, to ensure a medication is of significant benefit and minimal risk. All Food and Drug Administration (FDA) approved medicines from pain killers to antibiotics are put through exhaustive research and testing before they can be made available to the public. It is the final stages of research that volunteers are needed to participate in these trials. There is no such thing as a completely safe medication. However, through research many safer medications can be made available.
Why should I volunteer?
Participating in a clinical trial is an important decision. After identifying a potential study, please call and discuss it with one of our staff members. We encourage participants to bring a family member or friend to the first visit. All of your questions and concerns should be adequately addressed before agreeing to participate in a study.
Clinical research offers an opportunity to participate in the study of new medications and treatments that are in development. In exchange for your participation in a clinical trial, you will receive medical care for the condition under study, medication, and comprehensive evaluation, all at no charge. You will be compensated for your time and effort.
Participating allows you to be more involved in your own health, gives you the chance to try new treatments that may be more effective prior to them being widely available to everyone else, and helps improve quality of life for your community, your children, and future generations by contributing medical knowledge. In any event, you will have the satisfaction of participating in something that may not only benefit yourself, but society as well. Optimum Clinical Research, Inc. makes the process of participation easy and efficient.
Who can participate in a clinical trial?
Before participating in a research study, a participant must qualify for the trial. Some clinical research trials seek participants with a specific illness or condition to be studied, while others need perfectly healthy volunteers. All clinical research trials have criteria regarding who is qualified to participate. Following an inclusion/exclusion criteria is imperative to produce reliable results and protecting patients from unnecessary risk. The qualifications that someone must have to participate in a clinical study are called ‘inclusion criteria’. Conversely, criteria that bars someone from participating are called ‘exclusion criteria’. These are based on factors such as severity of the disease, possible interactions with current medications, and other medical conditions that might put someone at an increased risk of complications. Protecting patient safety is the primary reason someone would not be allowed to participate. However, just because someone doesn’t qualify for one study, doesn’t mean they wont qualify for the next. Don’t be overly disappointed if you don’t qualify to participate. We would love to see you in one of our studies but we are never willing to risk your safety or corrupt the research data to do it.
What are the risks and benefits of participating in clinical research?
Studies that are well-designed and well-executed are the best approach for eligible participants to:
- Be more involved in your own health.
- Have time to ask questions. We love to teach! Research visits are not as time constrained as regular medical appointments. If you want, we take the time to teach you about your condition and what you can do to help yourself .
- Have the Opportunity to try new treatments, that may be more effective, before they are made available to everyone else.
- There is never any cost to participate in a legitimate clinical research trial (don’t get scammed!). Even if you have medical insurance, it is never billed for research related activities.
- All labs, exams,procedures, tests, and medications are provided at no cost to you. Depending on the study, things like diabetic test strips and blood pressure monitors are also supplied.
- Participants are paid for their participation.
- Participating in clinical trials helps add to the sum of medical knowledge. Disease and suffering will be reduced for people around the world.
- Studies are confidential. Participation is never reported to insurances, employers, etc.
- The study medication may not work for you. Everyone is an individual and some may not respond to the treatment.
- The study may require more time and attention than other medical treatments, including visits to the study office, more medications, or recording information on a daily log.
- There can be side effects to the new medication, ranging from mildly annoying to life-threatening.
How will participant safety be protected?
The ethical codes and laws that govern medical practice also apply to clinical research. All of the studies OCR conducts are federally regulated. Mandated safeguards are in place to protect participants. The Studies adhere to a strictly controlled protocol, a research plan which outlines what researchers will do during the study. During the progression of the clinical trial, researchers report the results of the trial to the F.D.A., sponsors, and independent review boards. Study protocols are continually being reviewed and revised with patient safety in mind. Patient’s names are never reported with the study data, names will remain confidential, and are never revealed to the public, sponsors, or governmental agencies. Participants may withdraw from a study at any time for any reason. Study doctors may also discontinue participants if they ever feel a patient’s safety is a risk.
What should people consider before participating in a clinical research study?
Get informed. Call or email and ask questions. We always want you to understand the study and feel comfortable participating. Here are some of the common questions that may help you decide if participating is right for you.
- What is the purpose of the research?
- What does the medication do?
- What are the benefits of participating in this study?
- What are the possible side effects?
- How long is the study?
- How many visits are there?
- How much will I be compensated?
- Who will be in charge of my care?
What is informed consent?
The purpose of informed consent is to give you all the details you need to make a decision about participating in a clinical trial. Informed consent is not a one time event. It is an ongoing process throughout one’s study participation. An informed consent document contains information such as the study’s purpose, length, procedures & tests, risks, and potential benefits. The study is discussed with participants and the informed consent document will be reviewed. Participants are given as much time as they need to read through the document and the participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Still have questions? Please contact us anytime. We look forward to hearing from you!