Clinical Trials for Eye Diseases – Experimental Drugs and Devices
Clinical trials are common in all categories of medicine and health. A clinical trial is a carefully controlled test of a new drug or medical device on a preselected group of human patients. In the USA a clinical trial is conducted under the direction of the Food and Drug Administration (FDA) to evaluate the safety and efficacy of a new drug or device before it is made available to the general public. Trials may be sponsored by various organizations including physicians, medical institutions, voluntary groups and pharmaceutical companies as well as federal agencies.
Who can participate in a clinical trial?
If you are interested in playing a more active role in your own health care, or wish to gain access to new research treatments before they are generally available, you may wish to participate in a relevant clinical trial. In this way you may help others by contributing voluntarily to medical research.
All clinical trials have guidelines about who can and cannot take part and these inclusion or exclusion criteria are vital to producing reliable results. Inclusive criteria are the things participants must have in order to participate and exclusion criteria are factors that would disallow someone from taking part. Factors such as age, gender, the type and stage of the disease and medication and treatment history will affect whether or not a person can be included in a controlled clinical trial. These factors are not used to accept or reject individuals personally, but rather to identify appropriate patients and keep them safe. Participants are free to leave a clinical trial at any time, but should give the researchers the reason for doing so.
The benefits of participating in a clinical trial
Clinical trials allow participants to:
- Take a more active role in their own healthcare
- Possibly help other sufferers benefit from the medical research
- Have the opportunity to try new treatments earlier than the general public
- Obtain expert medical care at leading medical facilities
There are risks to clinical trials which should be seriously considered:
- The clinical trial will demand more time than regular treatment such as journeys to the study site, hospital stays or complicated dosage instructions.
- The treatment being tested may not be effective for the participant, or he or she may end up in a control group not receiving treatment at all.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment. Side effects are undesired actions or effects of the experimental drug or treatment. Adverse effects may include headaches, nausea, hair loss, skin irritation or other physical problems. Treatments must be evaluated for both immediate and long-term side effects.
Which isn't to say that there aren't safeguards in place to protect participants as much as possible during clinical trials. For example, there are ethical and legal codes that govern such trials, and most are federally regulated as well. Each study must have a carefully controlled protocol and a detailed plan stating what the researchers will do during the trial. Every clinical trial in the US is monitored by the Institutional Review Board (IRB), a committee of professionals who ensure that each trial is ethical and risks are minimized. There are also confidentiality rules in place that keeps participants anonymous when the study results are later published.
What is a control group?
A control is the standard by which the results are evaluated. In many clinical trials, one group will be given the experimental treatment while the control group will be given either a standard treatment for the illness, or a placebo (a substance which will have no pharmacological effect).
Taking part in a clinical trial
If you are considering participating in a clinical trial, you should get as much information as possible about the study before making a final decision. Questions you may want to ask include:
- What is the study’s purpose?
- Who will be participating in the trial?
- What kinds of tests and treatments can I expect?
- Is this the first time the treatment is being tested?
- Do the researchers have faith in the effectiveness of the experimental treatment?
- How will I know if the treatment is working?
- How does the new treatment compare with my current treatment?
- How long will the trial last?
- Will I be required to stay in a hospital?
- Will there be any long-term follow-up care required?
- Who will pay for the treatment?
- Am I entitled to any reimbursement for expenses?
- Will results of the study be provided to me at the end of the trial?
What are the phases of a clinical trial?
Phase I is when researchers test an experimental drug or treatment in a small group of 20-80 people to evaluate its safety and side effects and determine proper dosage.
Phase II is when the treatment is given to a larger group of 100-300 to evaluate its effectiveness and further test its safety.
Phase III is when the treatment is given to groups of 1000-3000 patients to confirm its effectiveness, learn more about side effects and collect additional data which will allow the treatment to be used safely.
Phase IV is post marketing studies which collect information about the practical risks, benefits and optimal use of the treatment.
Finding clinical trials
The US National Institutes of Health and the National Library of Medicine have created a website, ClinicalTrials.gov, with up-to-date information on clinical trials currently going on in the USA. Their database provides information on studies being performed for a wide range of diseases and conditions. Click here to see the list of current clinical trials related to eye disease.
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