Generally, you can participate in only one trial or study at a time. Different trials have different criteria, so being excluded from one trial does not necessarily mean exclusion from another. It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical trials include diverse participants, the study results may have a much wider applicability.
Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people. Many older people have special health needs that are different from those of younger people.
For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages or amounts of a drug to have the right result. Also, some drugs may have different side effects in older people than younger people.
Having seniors enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people. Researchers know that it may be hard for some older people to join a clinical trial. For example, if you have many health problems, can you participate in a trial that is looking at only one condition? If you are frail or have a disability, will you be strong enough to participate? If you no longer drive, how can you get to the study site?
Talk to the clinical trial coordinator about your concerns. The research team may have already thought about some of the obstacles for older people and have a plan to make it easier for you to take part in the trial. Read more about diversity in clinical trials. The Protocol: The trial protocol is basically the rulebook for the trial, which describes what the research question is; clearly identifies the population of patients to be included in the study; and describes exactly how the treatment is to be given to eligible patients.
Any physician involved in the study would have a copy of the protocol, and would have to adhere to all of the rules and procedures in it. More info on trial protocols. The Informed Consent: Each patient who considers taking part in a clinical trial must provide informed consent. Then, they decide:. Whether there will be a control group and other ways to limit research bias. Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
Purpose: Safety and dosage. During Phase 1 studies, researchers test a new drug in normal volunteers healthy people.
However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer. Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body.
Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are. As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits.
This is important to the design of Phase 2 studies. Purpose: Efficacy and side effects. In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed.
Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial. Instead, Phase 2 studies provide researchers with additional safety data. See our User Agreement and Privacy Policy. See our Privacy Policy and User Agreement for details.
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