Thinking about participating? Let’s review some basics and frequently-asked questions.
What is a clinical trial?
– A scientific process designed to test the safety, effectiveness, and side effects of an investigational medicine or device. Today, medications require FDA approval before they become available for purchase, and FDA approval requires clinical trials to demonstrate that the medications are effective and safe. Nearly 80% of clinical trials fail simply due to under-enrollment. Without participation, many potentially life-saving treatments would never reach patients.
Participating has both risks and benefits. Please see our FAQ below.
Contact us today to see what studies we have for you.
– Treatment may not be effective for everyone; some individuals simply do not respond to study treatment.
– There may be adverse reactions or side-effects to the study medication.
– Some study-specific protocols may require a lot of time, if frequent clinic visits or particular dosages are required, for example.
– Take an active role in your own medical care; especially if current treatment is ineffective or adverse.
– Obtain expert medical care form leading health-care professionals during the trial.
– Gain access to treatments not available to the public.
– Access to diagnostic procedures required by the study at no cost to you – MRI, PET Scan, X-Ray, etc.
– Help others by furthering medical research. – Meet others battling the same illness as you during clinic visits.
– Clinical trials are a process by which all modern medications get tested before they are released to the general public. Modern medicine and research relies on these studies and their participants to advance our understanding and treatment of disease. Gaining access to promising new medications may indeed help the individual participant, but the knowledge the scientific community gains from trial data will become indispensable in developing medications for future generations.
– Nearly 80% of clinical trials fail due to under-enrollment. Meaning that too many highly promising treatments and medications never see the light of day simply because the trial does not have enough patient data to satisfy FDA requirements.
If you have any interest in participating in a clinical trial, you will schedule an Initial Screening Visit with our clinic. During this visit, we take a personalized approach to each individual, and interview you about various medical and personal factors that will help determine whether you are eligible to participate in a particular study. Each study has specific eligibility factors which determine a patient’s admittance. These eligibility factors are predetermined by the group developing the clinical study, and are centered around the hypothesis (expectations and goals) of the study. We will go over study-specific eligibility criteria with each individual during their Initial Screening Visit.
Yes, even once you agree to participate in a study, you can withdraw at any time and for any reason. Furthermore, before you join, the study team will explain the study, everything required, and all potential benefits and deterrents to participating. This is called “Informed Consent”, and is required by the FDA and IRB before any individual may join an active clinical trial.
No, participating in a clinical trial has no cost to you. In fact, reasonable financial compensation for time and travel is often provided to study participants for each visit.
We always recommend you consult with your primary care physician about any medical treatment options you may be exploring, including clinical trials. Overall, participating in a clinical trial normally has no effect on your health insurance. Meanwhile, current treatment is examined on a case-by-case basis during the pre-screening interview, to determine if a patient’s medical history and current medication would be conducive to clinical trials participation.
– There are several ways to learn about clinical trials enrolling in your area. The most direct resource available is www.clinicaltrials.gov— a free public database containing information about all active clinical trials in the United States.
– Additionally, some researchers place ads in newspapers, radio, local television, or social media—searching for these online is always beneficial.
– Your own healthcare provider may also be hosting trials themselves, or may have been contacted by a research team—it is always good to ask your regular doctor about any possible clinical trials you may be eligible for.
– Researchers often host educational events throughout various support groups, advocacy groups, and community/church events—inquiring around your immediate community and peers may be a great way to learn about some personal experiences your friends or colleagues may have had with clinical trials.
In a clinical trial, researchers are testing a new treatment—vitamins, exercise, a new drug, or a new treatment device—and comparing it to a standard treatment and/or placebo. In short, clinical trials are studies that evaluate the effectiveness of a new medical intervention. Whereas, observational studies involve no intervention—participants are only observed while their health and some special factors are monitored quantifiably, like cholesterol or insulin level. Simply put, observational study participants don’t take any medications, they help researchers gather information to better understand a medical problem—such as answering a questionnaire about lifestyle choices like diet and exercise to determine common patterns in people who develop lung cancer as opposed to people who do not.
– The development of a new medical treatment usually takes several steps, to help researchers ask and answer questions in a controlled way, which expands their understanding of the treatment itself and its effects on people. Researchers separate a trial in to several phases, carefully designed to study specific hypothesis(questions) about the treatment.
– Phase I: These first studies in people determine how a new drug should be administered (orally, by injection, ect.), how much of the drug is appropriate (dosage range), and how often the drug should be administered (frequency). A Phase I trial usually enrolls a small number of people for a short amount of time.
– Phase II: These studies provide information about how well the drug works, what additional effects the drug may have, and information about their safety and/or potential benefit. Phase II studies usually enroll a larger amount of patients, and extend for several weeks or months.
– Phase III: There late-stage trials compare the effects of a new drug that has been demonstrated to be promising, with the effects of the standard treatment for a given illness and/or a placebo. Phase III trials usually involve numerous patients and doctors across a range of clinics nationwide, and last several months.
– A placebo is an inert form of a study medication. It looks exactly like the study medication but has no active ingredient or physiological effect on the patient.
– A placebo is a standard scientific practice used for a “control group” in any given research, it allows researchers to compare actual physiological effects of a drug with the perceived psychological effects experienced by a patient.
The FDA monitors all study protocols to ensure all practices are safe and appropriate, the IRB reviews all information about each study to ensure information is truthful and presented ethically. The IRB also requires informed consent prior to study admittance, to certify that each participant has been fully informed of and fully understands and agrees to all steps, potential risks, and requirements of study participation. Patient health and wellbeing is consistently monitored throughout each study visit, and any signs of adverse reaction stops treatment immediately.
Study participants are compensated for their time and travel. Typically, the compensation is per clinic visit. In some clinical trials, sponsors may also provide compensation for lodging, meals, or transportation.
Modern medical research is driven mostly by the private sector, which means drug companies that fund our research teams, along with trials volunteers are the driving force behind scientific progress in the fight against various diseases. Almost any modernmedicine you may be familiar with or comfortable with using today has gone through several clinical study phases, and was tested by numerous trials participants before it became available to you or your doctor. These study participants are treated as individuals, who are taking an active role in their own health care, while simultaneously contributing to our fight against their illness. Participant health and safety are closely monitored throughout the entire study process, and any negative signs or changes cause study treatment to be stopped immediately. Participants can also quit the study at any point and for any reason; and are also provided all study specific information prior to even consenting to participate in the study.
If you agree to join a clinical study, you go through a process called informed consent. By informed consent, you are given all key facts about the study before you decide whether or not to participate. These facts include details about the study approach, the intervention actually given in the study, the possible risks and benefits, and the tests you may have. The researcher will give you written information called a consent form that goes over all these key facts. If you agree to take part in the study, you will be asked to sign this form. You are encouraged to take the form home and discuss it with your family, friends, or doctor before you make your decision. We want you to feel comfortable with participating, and know exactly what is going on and why, every step of the way; thus, you are always encouraged to ask any questions you may have for the study team at any time.