Clinical trials can be very important in curing disease and finding ways to help prevent a host of ailments.
Have you or your senior loved one ever considered becoming part of a clinical trial?
Researchers across the globe receive funding through a variety of sources, including government endowments or federal agencies, foundations, pharmaceutical companies, organizations and universities, in order to answer the most perplexing questions about health and disease that the world’s population faces.
One such funding source is the National Institute on Aging (NIA), which will seek ways to improve cognition, decision making, mobility and independence of older people in the near future.
Another area of study will be conducted by Johns Hopkins University, Baltimore Johns Hopkins Roybal Center. They will review the informal support resources of vulnerable older adults focusing on the transition of health care services from traditional institutions like nursing homes to home- and community-based models. Their research will include key family members and caregivers.
Family caregivers and their senior loved ones play a vital role in the clinical trial effort, whether they are healthy individuals or suffering from a chronic illness.
What is a Clinical Trial?
Research done with human subjects is called a clinical trial. It can be the fastest way to develop new treatments that can improve our health. They are also used to compare a new treatment to a currently available one to see which is more effective.
Clinical trials investigate theories for prevention, diagnosis, treatments or cures for diseases. They can also study quality of life outcomes for people who suffer from chronic diseases.
There are two kinds of clinical trials, interventional and observational. An interventional clinical trial uses experimental therapies in a controlled environment. They could involve a medical device, medication, diet, procedure or a behavior change. Safety and effectiveness are studied through specific measurements such as vital signs.
An observational trial monitors a large number of individuals over a period of time and studies the effects of treatments over time.
Clinical trials have established rules and are monitored by committees that oversee the study for safety and compliance with procedure. All aspects have to be approved and monitored.
Each trial has its own criteria regarding who can participate, how long it will be performed, and where it will be carried out (facility, home, lab, doctor’s office, etc.).
Clinical Trial Phases
Phases of a trial are determined by the Food and Drug Administration (FDA). It has set up five phases or categories detailing the characteristics of the particular study.
- Phase 0 – this has very little human interactions, it is the exploratory stage.
- Phase 1 – this stage usually involves healthy individuals, often times a small group of 20-80 people, looking at a new drug or treatment including any adverse side effects or dosage ranges, it often involves studying how the drug works, how it is absorbed by the body and how it is excreted.
- Phase 2 – at this point, a drug is given to a larger group of participants (100-300) with data gathering conducted to compare participants’ reactions who receive different treatments. It often involves a drug and a placebo for comparison. The effectiveness and safety of a drug or treatment is a focus of this phase.
- Phase 3 – at this point the drug from phase 2 would be studied in different dosages and its effects compared among the many participants (1,000-3,000). It could also involve combining the original drug with other medications to test how it will interact and be effective in the presence of other drugs.
- Phase 4 – these studies are conducted after the FDA has approved the drug for use and it is marketed to the public. It is designed to continue to monitor the drug’s effectiveness, any side effects and points about its optimal use such as time of day taken and restrictions.
Should You or a Senior Loved One Join a Clinical Trial?
Each clinical study will have selective criteria about who is eligible. Some want healthy people, some want women only or men only, some want a person with a specific disease or who is taking a particular medication, and some depend on geography or age.
If you are interested in joining a study about which you’ve heard, it’s a good idea to contact them and see if you qualify. Once you are accepted they will explain the benefits and risks, which serves to educate you so that you can provide informed consent.
You should feel fully informed and comfortable with the trial before you begin including potential side effects, procedures to be performed, length of study, and what you are expected to do throughout the course of the study.
Some studies may not accept you or your loved one but you can participate by using the device or experimental medication through an Expanded Access Program.
One reason for joining a study is to be an active participant in health care, yours and that of others. If there is a specific disease for which you would like to be included, you would be given access to potential beneficial treatments before they are available to the public.
Be aware there may be unpleasant side effects or the treatment may have no effect at all. Participants are typically free to leave a clinical trial at any point if desired by just letting the researchers know of your decision.
Because we desire to further clinical research into prevention, treatment and cures for many chronic diseases which affect our seniors including Alzheimer’s and other dementias — and because we want to make readers aware of clinical trial opportunities — we have become CureClick Ambassadors. In order to do this, we have participated in training and agreed to provide only links to available research studies and have no influence over who is accepted or denied clinical trial participation.
What this means is that we are now part of a community of those trained to share information and resources regarding various clinical trials. We will only share with our family caregiver community those trials that we feel are pertinent to aging issues, such as dementia.
If our information sharing results in acceptance of someone into a trial, we will be given a small “reward” or stipend for connecting them with a study, which will help support Senior Care Corner.
Wouldn’t it be exciting to know that participating in a clinical trial not only improved the health of your senior loved one (or yourself) but also changed the face of a disease like Alzheimer’s?