You want to stick WHAT!! in me. (Clinical trials)

Member Name: Milk Maid

Product:	Clinical trials
Date:	04/01/04 (71 review reads)
Rating:

Advantages: help medicine, save lives, evolve our knowledge

Disadvantages: side effects, may not be useful, not everything may be told to the patient

This is my understanding of clinical trials. I have had to research this, as I am about to use clinical trials in my studies. This is an amalgamation of my findings, which I hope is a good outline for understanding.

A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

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.
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the
health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
The different trials are as follows:

Treatment trials test new 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, vitamins, vaccines, 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.


Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test a new 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 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 study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effect
iveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the 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.
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 to clinical trials.
· There may be unpleasant, serious or even life-threatening side effects to treatment.
· The 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
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Failure of a clinical trial can carry a big price tag. When Synergen stopped the Phase III trial of Antril, the $100 million the company had invested in the drug was exclusive of manufacturing costs, which included construction of what the firm billed at the time as "the largest pharmaceutical protein manufacturing plant in the world."
The Antril failure forced Synergen to terminate 375 jobs--60 percent of its work force--and close down both its manufacturing plant and its Japan office. Synergen's stock plummeted 49 percent the day of the restructuring announcement.
At the time Sy
nergen was not criticized for the design of the Antril trialsQsufficient numbers of patients were enrolled, and the company was performing the trials in a targeted subpopulation of patients who appeared to most benefit from the drug. But some industry watchers suggest that the company should have pursued Antril's effectiveness in rheumatoid arthritis first, before tackling the complex and ill-understood syndrome of sepsis.

A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

If you have any concerns about the ethics or the practice of clinical trials, the society of clinical trials may be able to advise or assist @ www.sctweb.org

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