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What is Covance?
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development companies. With the most comprehensive portfolio of preclinical, clinical development and commercialization services, Covance provides industry-leading services, the world’s largest central laboratory network, and a global team of clinical trial and commercialization experts.
With clinical research units throughout the U.S. and Europe, we enroll people to participate in clinical research studies to test new investigational medications, and approved medications for new treatments. Covance Clinical Research Units are part of the Phase I/IIa drug development portion of Covance.
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How are new drugs approved?
Before a medication can be prescribed, it must undergo an extensive testing and approval process. First, the investigational medication goes through rigorous preclinical testing. If it is permitted by regulatory agencies for the next phase of drug development, the investigational medication is then tested for safety in humans through clinical research studies. If endorsed by regulatory agencies after that, the investigational medication is further tested for both safety and effectiveness in patients with the disease or disorder it is intended to treat. The sponsor then submits a report (New Drug Application) to the appropriate regulatory authority, who either approves it, rejects it, or requires more testing.
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What types of clinical research studies do the Covance CRUs conduct?
Covance CRUs conduct Phase I and Phase II/III clinical research studies. Phase I tests investigational medications in healthy people. Phase II/III test investigational medications in people with certain medical conditions. Some clinical studies are conducted with medications already approved by regulatory agencies, and some clinical studies may involve testing on medical devices.
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Who can participate in a study?
The clinical studies conducted at our CRUs generally require that you are at least 18 years of age. Medical eligibility requirements vary with each clinical study. Phase I clinical studies require that you meet the strict healthy qualifying criteria determined by the study protocol - this can include restrictions on smoking, medications, recreational drug use and alcohol. Phase II/III clinical studies also have strict qualifying criteria similar to Phase I clinical studies, with the exception of the need for having certain medical conditions.
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How often can I participate in a study?
For your safety, at Covance there is a minimum timeframe that must be observed after completing a study before you may qualify to participate in another study - in the US it is usually 30 to 90 days, in the UK it is 3 months. In addition, you may only take part in one radiolabeled study per year.
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What are the risks and benefits of participating in a study?
Potential risks and benefits vary from study to study. However, if you are interested in participating in a specific study, potential risks and benefits will be explained to you before you give your consent to participate. You will also be able to ask questions of our clinical staff if you have any concerns that are not addressed.
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What is the Informed Consent process?
You are encouraged to ask questions at any time during the clinical study - from the screening visit through the end of the study. One part of the Informed Consent process involves reading and signing a Consent Form before you participate in any procedures. This form outlines the purpose of the study, what will happen during the study, risks and benefits of study participation, and background information on the investigational medication, including other studies involving the medication, along with other elements to help you decide if you want to participate. You will receive a copy of the Consent Form for your records. Signing the Informed Consent Form does not obligate you to participate; you may decide to withdraw from the screening visit or clinical trial at any time.
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What is the selection process?
To participate in a study, you must first call our Recruitment Call Center. A recruiter will determine if there is a clinical study for which you may be qualified, based upon the information you give about your health and health history. This is called 'phone screening.' If you are eligible, you will then be scheduled for an on-site screening visit at a clinical research unit for further eligibility evaluation. Based on results of the screening procedures, you will be notified as to your eligibility for the study.
Please note we cannot assess your eligibility via e-mail or conventional mail, but if you contact us by either method we will call you back to complete the phone screening process.
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What happens during a screening visit?
Your screening visit will take approximately 2-3 hours. During the screening visit our medical team will explain all aspects of the study to you and allow you to ask any questions that you may have regarding your participation. You will be given a Consent Form which will require your signature before any procedures may occur. If you agree to the screening visit procedures, you will then undergo a thorough medical examination, involving a detailed medical and social history, blood and urine tests, drug screen, measurements of your blood pressure and pulse as well as a heart trace (ECG). You will be asked to provide blood and urine samples to assess your health. Your blood sample may also be tested for HIV and the Hepatitis B virus, and your urine sample may also be tested for nicotine, recreational and other drugs. You may also be tested for alcohol levels. The results of these tests and procedures coupled with the additional study requirements specific to the clinical study will determine whether or not you are invited to participate in that study. All information you provide and your screening results will be treated in the strictest confidence.
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What is BMI?
The BMI, or body mass index, is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is a useful tool to estimate a body mass based on how tall a person is. BMI requirements are defined in each clinical study and must be met in order to become eligible for participation.
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Will I be tested for nicotine, alcohol, recreational drugs, HIV and pregnancy?
Most clinical studies will require the above tests, sometimes more than once during a study.
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What is involved in participating in a study?
Phase I clinical research studies require one or more residential stays at the research clinic, and may require multiple outpatient visits and at home dosing. The length of the confinement periods and number of outpatient visits are dependent upon the requirements of each study.
When you stay at the research clinic, you will have multiple blood draws, ECGs, physical exams and vital sign checks. Between procedures, you may have time to read, study, watch TV, play games, etc. Other recreational items such as a pool table, DVDs, board games and internet service may be available but vary based on the research clinic location.
Phase II/III clinical research studies usually do not require residential stays at the research clinic, and will consist of multiple outpatient visits and follow-up phone calls.
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What rules must I follow while staying at the CRU?
Most of the research clinic rules are based on respectful behavior toward yourself, fellow study participants and Covance staff. Activity will be restricted in that no tobacco, alcohol, caffeine, medications, or strenuous exercise is allowed, unless otherwise specified by study restrictions. You are expected to eat all food as provided by the research clinic, eat only the food provided, and be on time for all study procedures. Typically, visitors are not allowed.
A complete list of rules will be provided at the screening visit or upon check in.
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What should I bring with me if I am staying at the CRU for a study?
You may bring personal care items and clean clothes sufficient for the period you will be required to stay at the CRU. Footwear is to be worn at all times when you are not in bed. You may bring a personal laptop computer, video game system, books and magazines, and craft items. Covance will not be responsible for loss or theft of personal items.
A complete list of items you may and may not bring with you will be provided at the screening visit.
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How is my participation kept confidential?
Your privacy will be respected by Covance staff and no information will be given out about your participation and/or your medical information unless required by law. For example, the Sponsor and its representatives, applicable regulatory agencies such as the US Food and Drug Administration, and the authorized independent ethics board may inspect your clinical research study medical records, which may include your name, address and other personal information that identifies you. If necessary, some or all of your records may be copied during these inspections. Because of the need to use information as noted above, absolute confidentiality cannot be guaranteed.
The results of the clinical research study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.
In Europe, Covance is required to contact your general practitioner to inform them that you have participated in a clinical research study.
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How are the rights and welfare of study participants protected?
Clinical research studies are conducted by qualified medical staff and physicians. Additionally, various worldwide agencies have regulations to protect clinical research participants and standards for how studies are conducted. For example, an independent ethics board reviews each study protocol and associated materials. This review is conducted to make sure the study is scientifically and ethically sound. The independent ethics board oversees the processes that the CRU uses for informing you about clinical research studies, including why the study is being done, what will happen during the study, risks involved and previous study results that may impact an individual’s willingness to participate.
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Where can I find additional information on clinical trials?
Additional resources for clinical trial listings and more information about clinical trials in general can be found at:
ClinicalTrials.gov
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world.
CenterWatch.com
CenterWatch.com provides an extensive list of clinical trials being conducted internationally. The web site also lists promising therapies newly approved by the FDA.
CISCRP.org
The Center for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation and the role that each party plays as a participant in the process.
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