Clinical Trials
From DrugPedia: A Wikipedia for Drug discovery
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| + | ==Participation in Clinical Trails== | ||
| + | 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. | ||
| + | |||
| + | All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. | ||
| + | |||
| + | ===Informed Consent=== | ||
| + | Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. | ||
| + | |||
| + | ===Benefits and Risks of participating in a Clinical Trial=== | ||
| + | '''Benefits''' | ||
| + | |||
| + | Clinical trials that are well-designed and well-executed are the best approach for eligible participants to: | ||
| + | |||
| + | * Play an active role in their own health care. | ||
| + | * Gain access to new research treatments before they are widely available. | ||
| + | * Obtain expert medical care at leading health care facilities during the trial. | ||
| + | * Help others by contributing to medical research. | ||
| + | |||
| + | '''Risks''' | ||
| + | |||
| + | There are risks associated with clinical trials. | ||
| + | |||
| + | * There may be unpleasant, serious or even life-threatening side effects to experimental treatment. | ||
| + | * The experimental treatment may not be effective for the participant. | ||
| + | * The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, | ||
| + | more treatments, hospital stays or complex dosage requirements. | ||
Revision as of 08:13, 6 August 2008
Clinical Trials are conducted to determine whether new drugs or treatments are both safe and effective.
Clinical trials help physicians discover the answers to the following questions:
1.Is the treatment safe and effective? 2.Is the treatment potentially better than the treatments alredy existing? 3.What are the side effects of the treatment? 4.Does the treatment have any possible risks? 5.How well does the treatment work?
Contents |
Types of Clinical Trials
- Treatment trials : test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- 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, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic trials : are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials : test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) : explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Phases of Clinical Trials
Clinical trials are conducted in four different phases. The trials at each phase have a different purpose and help scientists answer different questions.
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
| Phases | Number of Patients | Duration | Purpose | Percent of Drugs Successfully Tested |
|---|---|---|---|---|
| Phase I | 20-100 | Several Months | Safety | 70 % |
| Phase II | 100-500 | Several months to 2 years | Efficacy | 33 % |
| Phase III | 1000-8000 | 1-4 years | Safety, Efficacy and Dosage | 25-30 % |
| Phase IV (Post-Market Survelliance) | - | - | drug's risks, benefits, and optimal use | - |
Participation in Clinical Trails
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.
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Informed Consent
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
Benefits and Risks of participating in a Clinical Trial
Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
* Play an active role in their own health care. * Gain access to new research treatments before they are widely available. * Obtain expert medical care at leading health care facilities during the trial. * Help others by contributing to medical research.
Risks
There are risks associated with clinical trials.
* There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
* The experimental treatment may not be effective for the participant.
* The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site,
more treatments, hospital stays or complex dosage requirements.
