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	Imaginis - Understanding Clinical Trials
		A clinical trial is an organized research study designed to investigate new methods of preventing, detecting, diagnosing, or treating an illness or disease, such as cancer.
		Clinical trials are typically conducted at universities, cancer centers, hospitals, or clinics.
		For example, the STAR clinical trial (Study of Tamoxifen and Raloxifene) is a Phase III trial that is enrolling 22,000 post-menopausal women 35 years of age or older who are at increased risk for developing breast cancer.
	imaginis.com /breasthealth/clinical_trials.asp (1285 words)

	Treatment of Alzheimer's Disease
		Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.
		While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
		Clinical trials are sponsored by government agencies: such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician- investigators; health care institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment.
	www.alzinfo.org /treatment/clinicaltrial/default.aspx (2257 words)

	University of Pennsylvania: School of Veterinary Medicine - Department of Clinical Studies, Philadelphia / Section of ...
		Strict adherence to treatment protocols during clinical trials is of vital importance both to the veterinarian and the pet owner to ensure that optimal treatment and patient care are provided.
		Clinical trials usually limit the use of additional supplements when the patient is being treated with an investigational drug.
		Clinical trials are very rewarding for the pet, its family, the veterinary investigator, and, perhaps most importantly, future patients with the same condition.
	www.vet.upenn.edu /departments/csp/research/clinical_trials (1409 words)

	Lilly Clinical Trial Registry - Terminology
		Clinical Trial / Study: Any investigation in humans intended to discover or verify the effects of an investigational drug or new use of an already marketed drug, and/or to identify any adverse reactions to the investigational drug with the object of determining safety and/or efficacy of the studied use.
		Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are respected and protected.
		This is the scientific institution that is independent of the sponsor of the clinical trial that reviews and approves the study protocol on ethical treatment grounds and ensures that each participant enrolled in the trial has given their informed consent to participate.
	www.lillytrials.com /docs/terminology.html (3236 words)

	West Coast Clinical Research - Clinical Trials
		Clinical trials are important to ensure that individuals receive safe and effective treatments for their health conditions, from heart disease to headaches.
		Clinical trials are performed around the world in various settings, including doctors offices, hospitals, research centers, and teaching institutions such as universities.
		Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.
	www.clinicalresearch.org /trials.html (1928 words)

	Facts About Clinical Trials in Vision Research [NEI Health Information]
		Clinical trials in vision research have led to new medicines and surgeries that have saved or improved sight for thousands of people.
		In other clinical trials, where a new surgery or device (not a medicine) is being tested, patients in the control group may receive a sham treatment.
		In some clinical trials, where the disease or disorder affects both eyes, one eye may be in the treatment group, and the other eye may be in the control group.
	www.nei.nih.gov /health/clinicaltrials_facts/index.asp (2705 words)

	About Clinical Trials
		Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle,) how often, and what dose is safe.
		Some clinical trials will pay people for participating in the research but they are rare, primarily because the National Institutes of Health wish to discourage patients from participating in clinical trials solely for financial purposes.
		Most clinical trial sponsors, however, will reimburse participants for reasonable travel and food expenses accumulated while they are in the trial.
	www.emergingmed.com /pub_AboutClinicalTrials.asp (1522 words)

	What Are Clinical Trials?
		Clinical trials in general, seek to answer specific scientific questions to find better ways to prevent, detect, and treat diseases as well as to improve overall care for people with disease.
		Clinical trials may test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
		In clinical trials, informed consent is the process of providing all relevant information about the trial’s purpose, risks, benefits, alternatives, and procedures to a potential participant, who then, consistent with his or her own interests and circumstances, makes an informed decision about whether or not to participate.
	www.oralcancerfoundation.org /facts/clinical_trials.htm (2111 words)

	ALS and Clinical Trials - The ALS Association
		Clinical trials carry out tests on people to see whether a candidate therapy is safe and works to counter the effects of a disease.
		Clinical trials often are double blinded, meaning neither the clinicians nor the patient knows which drug is taken: placebo (or standard treatment) or candidate treatment.
		Another adverse aspect to clinical trials is participants may have to give more frequent blood samples and keep a detailed record of symptoms than if receiving usual care for their illness.
	www.alsa.org /patient/article.cfm?id=781 (2568 words)

	Marie Osbourne's Interview with Dr. Mark McClellan
		McClellan: Well, Marie, a clinical trial is a research study in people that is designed to answer specific questions about health and there are all kinds of questions that we want to know the answers to today.
		Clinical trials are the best way that we have to learn about what treatments really work to help people improve their health.
		But it's important to keep in mind that clinical trials cover the full spectrum, there are also preventive clinical trials going on now, that help people find better ways to prevent getting illnesses in the first place -- that people who are perfectly healthy can enroll in.
	www.fda.gov /oashi/clinicaltrials/section113/113mcclellan.html (1494 words)

	Glossary of Clinical Trial Management Software (CTMS) Terminology
		A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial.
		The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects.
		Clinical trials are conducted to determine the effectiveness and safety of new drugs or treatments, or to find new applications for existing drugs.
	www.clinicaltrialsoftware.com /glossary.aspx (569 words)

	FAQs about Novartis Clinical Trials
		Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
		Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA).
		While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
	www.novartisclinicaltrials.com /etrials/clinicalTrialFAQs.do (738 words)

	Clinical trial - Wikipedia, the free encyclopedia
		Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions.
		The major difference between clinical trials and observational studies is that, in clinical trials, the investigators manipulate the administrationhole of a new intervention and measure the effect of that manipulation, whereas observational studies only observe associations (correlations) between the treatments experienced by participants and their health status or diseases.
		The power of a trial is not a single, unique value; it estimates the ability of a trial to detect a difference of a particular size (or larger) between the treated and control groups.
	en.wikipedia.org /wiki/Clinical_trial (1852 words)

	Vical: Clinical Trials: Clinical Trial FAQ
		Clinical trials, also known as clinical studies, are research studies in which scientists and doctors test new drugs and treatments to see if they will improve health.
		Phase IV trials: These trials are usually carried out after the drug or treatment has been approved by the FDA and is readily available for use in the general patient population.
		The purpose of Phase IV trials is to continue to study the effects of the drug or treatment on different populations and to look for side effects associated with long-term use.
	www.vical.com /clinicaltrials/faq.htm (1447 words)

	Entering a Clinical Trial
		Patients in a clinical trial, for example, receive their care in the same places that standard treatments are given-at cancer centers, hospitals, clinics, or doctors' offices.
		After patients join a clinical trial and it progresses, the doctors report the results of the trial to scientific meetings, to medical journals whose articles are approved by experts, and to various government agencies.
		Other trials compare two or more treatments in separate groups of patients who are similar in certain ways such as the extent of their disease.
	healthlink.mcw.edu /article/926242077.html (2576 words)

	What Is a Clinical Trial? - National Cancer Institute
		A clinical trial is one of the final stages of a long and careful cancer research process.
		These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occuring in people who have already had cancer.
		Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
	www.cancer.gov /clinicaltrials/learning/what-is-a-clinical-trial (482 words)

	Avastin Clinical Trial Information
		Clinical trials are important because they help doctors learn more about cancer and can lead to better treatments and care.
		Because Phase III trials are the largest, this is the type of clinical trial that cancer patients usually join.
		After a Phase I or II trial is completed, researchers look carefully at the results and decide whether to move on to the next phase of clinical trial or stop studying the treatment because it is not safe or effective.
	www.avastin.com /avastin/crcClinicalTrials.m (1496 words)

	Draft Clinical Trial Agreement (Site not responding. Last check: 2007-11-05)
		Additional questions regarding the agreement or University policies related to negotiation or administration of clinical trial agreements may be directed to the Contracts Officer assigned to your unit.
		Whenever an outside sponsor funds a clinical trial at the University, the parties must sign a written agreement that defines the scope of work and formalizes the understandings between the parties.
		Clinical studies involving the use of a sponsor’s confidential information will be accepted if: (1) the extent of confidential information shared with the University is limited; (2) the information is clearly identified by the sponsor as confidential: and (3) the sponsor agrees that the University will not be financially liable for disclosure.
	www.rgs.uci.edu /ora/sp/standardclinicaltrialagreement.htm (1958 words)

	Epilepsy clinical trial information - a list of ongong seizure research, therapy, and treatment evaluations in all 50 ...
		If you are interested in participating in a clinical trial, information can be obtained from the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland as well as many pharmaceutical, biotech and medical device companies, universities and other organizations.
		Participation in clinical trials offers the potential for new treatment options and allows patients to participate with researchers in driving the discovery of effective therapies for epilepsy.
		Clinical trials are done under the supervision of the FDA.
	www.epilepsy.com /clinical/clinical_trials.php (310 words)

	Wallis Stabilization System Clinical Trial
		The Wallis clinical study is a multi-center, prospective, randomized study comparing the safety and effectiveness of the Wallis device to the latest non-surgical treatment regimen including medication, physical therapy and spinal injections.
		The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is superior to non-surgical care at treating mild to moderate degenerative disc disease at one or two levels between L1 and L5 of the lumbar spine.
		Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
	www.spine-health.com /research/trials/wallis/wallis.html (844 words)

	Clinical Trials and Parkinson's Disease from MedicineNet.com
		You may have heard about clinical trials from your doctor, read or heard advertisements in the newspaper or on the radio, or found out about trials in your area through a support group or association.
		A clinical trial is a research program conducted in patients to evaluate a new medical treatment, drug, or device.
		The purpose of clinical trials is to find new and improved methods of treating diseases and special conditions.
	www.medicinenet.com /parkinsons_disease_clinical_trials/article.htm (383 words)

	OXiGENE - Clinical Trial Results
		Phase I clinical trials are designed to investigate a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
		The trial demonstrated that Combretastatin A4 Prodrug can be given safely at doses that significantly diminish the blood flow to malignant tumors, as evidenced by MRI (magnetic resonance imaging).
		The dose-limiting toxicity in the University Pennsylvania trial was tumor pain as assessed by the investigator.
	www.oxigene.com /vascular/trialresults.asp (475 words)

	ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: resources
		Choosing to participate in a clinical trial is an important personal decision.
		In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial.
		For those considering participation in a clinical trial, the following frequently asked questions are important in understanding the role of the participant and the unique process of clinical trials.
	www.clinicaltrials.gov /ct/info/resources (214 words)

	GlaxoSmithKline Clinical Trial Register - Welcome
		The GlaxoSmithKline (GSK) Clinical Trial Register provides an easily accessible repository of data from GSK-sponsored clinical trials, supplementing communications in journals, at scientific meetings, in letters to healthcare professionals and in approved prescribing information.
		GSK-sponsored trials are those for which GSK is ultimately responsible for all aspects of the study (e.g., regulatory approvals, site selection, protocol development, initiation, monitoring, safety reporting, and data analysis), even if some or all of these activities are transferred to another party.
		The Register provides scientific, non-promotional summaries of clinical trials in a consistent format, irrespective of whether the results may be viewed as positive or negative for GSK medicines.
	ctr.gsk.co.uk /welcome.asp (563 words)

	Clinical trial management - Wikipedia, the free encyclopedia
		Over the last ten years, getting patients and doctors into clinical trials has become the most delay-ridden aspect of the drug discovery and development process.
		A "straw poll" during a clinical project management training course revealed that virtually all clinical protocols have at least one amendment during the study.
		Attention to clinical protocol design, thus, is at least as critical as in phases I-II.
	en.wikipedia.org /wiki/Clinical_trial_management (1626 words)

	Lilly Clinical Trial Registry
		Clinical studies on Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.
		Trial Results by Therapeutic Area: Provides summaries of completed clinical studies and/or references to publications or scientific presentations for marketed products by therapeutic area.
		Trial Results by Product: Provides summaries of completed clinical studies and/or references to publications or scientific presentations for marketed products by product.
	www.lillytrials.com (407 words)

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