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Clinical Trials: Volunteers & New Drug Research

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

Definition: Clinical Trial

Clinical trials are defined as research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

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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:

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.

You can search for current U.S. clinical trials for a range of conditions at https://clinicaltrials.gov/ct2/search

Quick Facts: Clinical Trial






Latest Clinical Trials Publications

  1. Pediatric Neural Tumor Shrinkage Shown in Selumetinib Clinical Trial
    Early-phase clinical trial of selumetinib in children with common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas.
  2. Antidote: A Digital Health Company on a Mission
    Antidote matches the right patients with the right clinical trials, helping medical researchers make faster progress, and offering new treatment options to patients.
  3. Evaluating FDA Approach to Cancer Clinical Trials
    U.S. FDA is committed to meet needs of patients and health care communities in prevention, diagnosis, and treatment of cancer.
  4. AST-OPC1 Clinical Study for Spinal Cord Injury Patients
    Asterias Biotherapeutics AST-OPC1 treatment for spinal cord injury patients shown to help paralyzed patients regain function in arms and hands.
  5. UK Clinical Trial to Test Treatments for Vitiligo
    We are looking for people who have at least one patch of vitiligo that has appeared or worsened over the past year.

Full List of Clinical Trials Documents (72 Items)




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