About Clinical Trial
Clinical trial is a type of clinical research that involves human volunteers to determine how well new medical treatments, drugs, diagnostic procedures, and other therapies work. It is conducted to determine whether the new treatment is effective and safe before it can be offered to a large number of patients. It is also considered as the best way for researchers to find new ways to detect, slow, treat and hopefully someday prevent certain disease.
Clinical trial is also called an interventional study. In this, participants or those who volunteer to take part will receive specific interventions based on the research plan or protocol created by the investigators or those persons conducting the research. The interventions may include potential medication, other forms of treatment, or changes to participant’s behavior. It usually involves two groups, the control group and the experimental group. Control group is usually given with an inactive treatment called placebo while the experimental group is given with the intervention being studied.
Phases of Clinical Trials
The following are phases of clinical trials:
- Phase I – It is the most basic of clinical trial. In this phase, the new drug is tested to evaluate its safety, its route of administration, frequency, and safe dosage range. This is done to a small group of people about 20-80.
- Phase II – Based on the result of phase I, the said treatment will be test for a larger group of people approximately 100-300 and then, further evaluation of its safety and effectiveness will be done.
- Phase III – It is done to a much larger group people about 1, 000 to 3, 000 to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV – This phase is done to gather further information including the risks, benefits and optimal use of the new treatment or drug.
About Alzheimer’s Clinical Trials Facts
- Alzheimer’s is a progressive brain disorder that gradually destroys a person’s memory and ability to communicate.
- It is said that in 2006, the number of people affected with the disease was 26.6 million worldwide and it was predicted that by 2050, the prevalence is expected to quadruple in which out of 85 persons, 1 will be living with the disease. With this information, clinical trials should be conducted to discover and evaluate new medicines as well as other treatments, like exercise, diet, and even educational programs to better treat and hopefully to prevent Alzheimer’s disease someday.
- More than 100 clinical studies are recruiting participants. At least 50,000 volunteers are needed with or without the disease.
- Because clinical trials are experiments, as a result, there are some risks involved. However, the ethical and legal codes that govern medical practice can also be applied to this type of clinical research. It is also federally regulated with built in safeguards that protect the participants.
- In participating to this study, participants can play a more active role in their own health care. They can gain access to potential treatments before they are widely available. Often times, they can receive expert medical care at leading health care facilities and most of all they can help the future generations by contributing to research related to Alzheimer’s.
- On the other hand, there may be unpleasant or serious side effects to experimental treatment or it may not be effective. With this, participants should discuss and understand possible side effects with their doctor and if it is necessary, they have the ability to withdraw at any time because their safety is the most important.