Clinical Trials

Information and availability of federally and privately supported clinical trials conducted in the United States and around the world.

Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

During the clinical trial, the investigators: recruit patients with the predetermined characteristics, administer the treatment(s), and collect data on the patients' health for a defined time period. These data include measurements like vital signs, amount of study drug in the blood, and whether the patient's health gets better or not. The researchers send the data to the trial sponsor who then analyzes the pooled data using statistical tests.

The U.S. National Institutes of Health (NIH) organizes trials into five different types:

* Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

* Screening trials: test the best way to detect certain diseases or health conditions. * Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.

* Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

* Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).

* Compassionate use trials: provide experimental therapeutics prior to final FDA approval to patients whose options with other remedies have been unsuccessful. Usually, case by case approval must be granted by the FDA for such exceptions.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Participating in a clinical trial

Phase 0 and Phase I drug trials seek healthy volunteers. Most other clinical trials seek patients who have a specific disease or medical condition.

Locating Clinical Trials

Depending on the kind of participants required, sponsors of clinical trials use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go (such as doctor's offices), and personal recruitment of patients by investigators.

Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials.

Steps for Clinical Trial Volunteers

Before participating in a clinical trial, interested volunteers should speak with their doctors, family members, and others who have participated in trials in the past. After locating a trial, volunteers will often have the opportunity to speak or e-mail the clinical trial coordinator for more information and to answer any questions. After receiving consent from their doctors, volunteers then arrange an appointment for a screening visit with the trial coordinator.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization.

For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases the male partners of these women are also excluded or required to take birth control measures.

Search for current U.S. clinical trials at http://clinicaltrials.gov/ct2/search

Information Regarding Clinical Trials

Stroke Treatment Passes Safety Stage of Clinical Trial - Novel stroke treatment passes safety stage of UCI-led clinical trial - Sequential-growth-factor therapy holds promise for improving recovery outcomes...

MIRAPEX ER Approved for Treatment of Early Parkinson's Disease - FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinson's Disease...

VLP Pandemic Influenza Vaccine Study - Novavax - NOVAVAX Presents Positive Clinical Results at The World Health Organization Conference, Geneva, Switzerland - Positive Clinical Results from Pivotal Study of H1N1 Virus-Like Particle (VLP) Pandemic Influenza Vaccine in Mexico. Immunogenicity responses at all dose levels meet U.S. and European regulatory authorities recommended criteria for seroconversion and seroprotection - More than fifty percent of the volunteers already enrolled in Stage B of study.

Stroke Clinical Trial in UK - ReNeuron receives final regulatory approval to commence landmark stroke clinical trial in UK - ReNeuron Group announces that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final Favourable Opinion to ReNeuron’s proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke...

TOPICA'S Luliconazole IND to Begin Clinical Trials in Onychomycosis - FDA Accepts TOPICA'S Luliconazole IND to Begin Clinical Trials in Onychomycosis - TOPICA to Start Phase 1/2 Trial in Onychomycosis with Novel High-Concentration Luliconazole Solution.

Treatment of Advanced Waldenstrom's Macroglobulinemia - Clinical Trial - Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia.

Link to "Clinical Trial Volunteers and Drug Research Information" - http://www.disabled-world.com/medical/clinical-trials/