- What is West Coast Clinical Trials?
- What are Clinical Trials?
- Why are clinical research studies important?
- Why volunteer for a clinical trial?
- How safe are clinical trials?
- What are the risks/benefits to participating?
- Are there costs?
- Is there compensation?
- How long do studies last?
- How often can I participate in a study?
- What is a Contract Research Organization (CRO)?
- What are the different phases of clinical trials?
- What happens during a screening visit?
- What should I expect from a Clinical Trial?
- How do I participate in a clinical study?
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What is West Coast Clinical Trials?
West Coast Clinical Trials is an independent Phase I-IV CRO located in southern California. WCCT has been conducting clinical trials since 1998 and has been audited by the FDA and numerous pharmaceutical and biotechnology companies. Our location and access to a demographically ethnically diverse patient population allows us to do a wide variety of studies as well as specialize in ethnic bridging studies. With 120 beds and 30,000 square feet, a well-trained and qualified staff, and advanced technological procedures, we offer the experience, technology, and knowledge to conduct a wide variety of studies including:
• Bioavailability
• Bioequivalence
• Cardiac Safety (serial ECG)
• Drug-Drug Interaction
• Drug Delivery Systems
• Food Effect
• First in Human
• Single and Multiple Dose Pharmacokinetic
• Dermal Pharmacokinetics
• Single and Multiple Dose Pharmacodynamic
• SAD/MAD
• Vaccines
• Asian Bridging
• Age, gender, and race -
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What are Clinical Trials?
Clinical Trials are research studies designed to answer specific questions about medicines, devices, vaccines, or new ways of using known treatments. They are conducted at hospitals, universities, and doctor's offices and are the fastest and safest way to prove which treatments work best in patients.
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Why are clinical research studies important?
Clinical trials are essential to the development of new and potentially life-saving medications and treatments. Before the Food and Drug Administration (FDA) approves a medication for use, it must undergo three phases of clinical trials to assure its safety and efficacy. Therefore, study participants are essential to the development and release of medications and treatments, which are likely to improve the quality of life for millions of people across the country and around the world.
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Why volunteer for a clinical trial?
Participating in a clinical trial will provide essential information about how a medication is metabolized. Participants will find it a worthwhile experience for the following reasons:
• possible therapeutic benefit
• financial compensation for time and travel related to trial
• free physical exam
• new medical and pharmaceutical knowledge
• meet new people
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How safe are clinical trials?
At West Coast Clinical Trials the safety of volunteers and patients is our highest priority. Ethical and legal codes, which also apply to medical practices, are regulated by the government, and have safeguards to protect the participants. All clinical trials must be approved and monitored by institutional review boards and independent ethics committees to ensure low risk and high, positive results. Detailed protocols are written and followed closely by researchers. Furthermore, throughout the clinical trial, researchers must report and update their findings to government agencies and medical journals.
The names of the participants remain confidential, and participants have the right to refuse medication and leave at any time during the study for any reason.
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What are the risks/benefits to participating?
Participating in a clinical trial is a great way to play an active role in your own healthcare. You will receive information about the latest medical management for your condition and may have access to medications and treatments years before they become accessible to the public.
In the trials that have a placebo group, you will be informed if there is a possibility you will receive placebo medication. Placebo is an inactive pill, liquid, or powder that does not provide any treatment. It is often called a "sugar pill" by researchers and it is used in comparison to the treatment being tested to determine the treatment's effectiveness. Not every clinical trial uses placebos; some provide every participant with an active medication. Also, if at any time during a clinical trial you feel your condition is worse, you are free to withdraw from the study.
The same ethical and legal codes that govern medical practice also apply to clinical trials. Participants are protected by federal regulations and every clinical trial must be approved and monitored by an independent Institutional Review Board to ensure that the risks are as low as possible.
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Are there costs?
There are no medical costs. Study participants receive expert medical care, including blood tests, EKGs, x-rays, and more, at no cost during the course of a study.
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Is there compensation?
At West Coast Clinical Trials we understand your time is valuable, compensation may be provided for time and travel depending on the study. Please note that every study has different rates of compensation.
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How long do studies last?
Each study involves a specific amount of time, which varies by the drug that is being tested. There are three phases in the life of the drug before the drug is released to the public.
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How often can I participate in a study?
For your safety, at West Coast Clinical Trials there is a minimum time period between each study you participate in which varies between 30 and 90 days.
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What is a Contract Research Organization (CRO)?
Sponsors (whose drugs are being researched) often partner with CROs like West Coast Clinical Trials (WCCT) to manage their clinical research, provide operational management, recruit investigative sites, design and write protocols, complete administrative paperwork, and monitor sites throughout a trial.
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What are the different phases of clinical trials?
Phase I: A small group (few dozen) of normal, healthy volunteers try a new drug or treatment for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: A larger group (few hundred) of volunteers that have a particular disease or condition try the new drug to determine its effectiveness and to further evaluate safety and side effects.
Phase III: This is usually the final phase of testing before a drug is approved by the FDA. Hundreds to thousands of participants help in providing the efficacy, risks, and side effect information that is used to determine how physicians will prescribe the drug once it is approved.
Phase IV: Occasionally studies are done after a drug has been released to the public in order to gather additional information to determine a drug's optimal usage or to compare it to other existing therapies.
What’s involved in qualifying for a clinical trial?
Participants will be eligible for a number of clinical research studies depending on the following:
• age
• height
• weight
• medical history
• lifestyle habits
• availability (such as time or location—we are located in Southern California)
These criteria are used to identify appropriate participants and to keep them safe. Examples of these guidelines may include age, gender, type and stage of a disease, previous medical history, and co-existing medical conditions. It is important to understand that these criteria are not used to reject people personally, but to ensure that researchers are able to answer the specific questions they plan to study. -
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What happens during a screening visit?
For a screening visit, participants will come into our clinic located in Cypress, California (click here for a map) for 1-3 hours. Each participant will be informed of all aspects of the study and then able to ask any questions he/she may have. A participant will be handed an Informed Consent Form and asked to sign before any examination starts. If the informed consent formed is signed, the patient will undergo a medical examination, which includes detailed medical and social history, blood and urine tests, drug screen, blood pressure and pulse measurements, and a heart trace (ECG). The blood and urine samples are taken for a more extensive assessment of your health to test for HIV, Hepatitis B, nicotine, recreational and prescription drugs, and alcohol levels. The results of these tests as well as additional requirements specific to the study will determine whether or not you are eligible to participate. All information and all screening results for each participant will be treated in the strictest confidence.
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What should I expect from a Clinical Trial?
First, a potential participant must participate in an initial screening; call one of the numbers here to give your primary information. Then, an informed consent form will be signed (in order to educate each participants on the details of the study), and a physical exam will be conducted; this includes the following:
• measurement of height, weight, temperature, and blood pressure
• electrocardiogram (ECG) – a heart trace
• blood and urine test
• other possible diagnostic tests depending on study protocolPhase I/IIa studies may require one to several overnight stays at the clinic; these overnight stays vary by the requirements of each study. Once you begin a clinical trial, you may have blood draws, ECGs, physical exams, vital sign checks, and scheduled drug administration, but between procedures there may be a lot of free time to use the amenities we provide such as foosball table, cable tv, wireless internet, pool table, DVDs, board games, and others.
How are the rights and welfare of participants protected and what is informed consent?
If all conditions for a clinical trial are met, participants will be asked to sign an informed consent form, which recognizes a patient’s need to know about any procedure or treatment before he/she decides to have it and provides a full and extensive summary of the clinical study and the rights of participants. This form doesn’t require participants to enroll and stay in the study, and under no circumstances does this document ask a participant to give up his/her legal rights, but rather assists and informs participants.Clinical trials are conducted and led by qualified, experienced medical staff and doctors. Also, the government has regulations and standards to protect clinical trials participants and preserve the integrity of the study. Government agencies reviews and monitors the design and trial to ensure that each study is conducted scientifically, effectively, and ethically.
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How do I participate in a clinical study?
If you are interested in finding out if you qualify for a clinical trial please visit our Participants page.
Our representative will take your primary information, such as contact information, date of birth, height, weight, and types of studies you are interested in. If there is a study that you may qualify for, our specific research coordinators will contact you for further information for study specifics.