Before the Federal Drug Administration grants approval to a medicine or drug, tests have to be performed to prove both the safety and effectiveness of the new treatment. Clinical trials on actual people can only begin after extensive animal and laboratory tests.
Clinical Trial Phases
Clinical trials progress through four separate phases:
Phase I trials examine the new treatment’s safety. Side effects are identified. Only 20-80 individuals participate.
Phase II trials continue the work done in Phase I, with a larger group of patients.
By Phase III, up to 3,000 people may be participating. Phase III determines the drugs effectiveness, and how well it works compared to older treatments.
Phase IV trials occur after the FDA approves the drug, in order to monitor the treatment’s long-term effectiveness.
Why Volunteer for a Clinical Trial?
You gain access to new treatments quickly, and long before the general public. You receive the medication for free during the trial, and often for months after the trial. The doctors monitoring your condition will be leaders in their fields, allowing you to access the most informed medical care. Some facilities will even pay for your time.
By volunteering, you’re not only taking control over your own health, you’re also helping others who will benefit from the clinical trial’s results.
Are There Risks?
Well, yes. That’s one reason the FDA insists on clinical trials. The medical treatment may cause unforeseen side effects. There’s always the possibility that the treatment will have no effect on your condition. A clinical trial will also take up some of your time. You can leave a clinical trial at any time (although the researchers would probably appreciate it if you explain why you’re opting out). Also, your rights as a trial participant are outlined by the World Medical Association’s Declaration of Helsinki.
Erectile Dysfunction Clinical Trials
A common myth about erectile dysfunction is that if oral medication doesn’t work, the only other option is a penile implant. This is untrue. Thanks to erectile dysfunction clinical trials, male impotence can be treated in a number of ways. Clinical trials typically focus on new medications, both oral and topical, for erectile dysfunction treatment.
Why Participate in an Erectile Dysfunction Clinical Trial?
One of the most obvious motives for participating in a clinical trial is access to new treatments. Of course, you could be part of a control group, but either way, the advice you’ll receive from experts can be invaluable.
Participants in clinical trials are vital to the continued advances made in the field. Your participation in a research study near you can help doctors better understand and treat male impotence. Participating in a clinical trial may mean better sexual health for you and, quite literally, millions of others.
Frequently Asked Questions
What benefits do I get from participating in a clinical trial?
- excellent medical care, closely monitored and beyond the level of regular care
- the opportunity to receive early treatment that may help treat your condition
- the opportunity to contribute to medical research
- no cost, expenses covered and in many trials a small stipend is offered.
Am I assured of getting the new treatment?
Not necessarily. A clinical trial requires that some people receive the experimental treatment and some get either an alternate treatment or a placebo. Who goes in which group is determined randomly and the information is kept secret until the trial.
What happens if I get a placebo?
The ethics standards followed by clinical trials in this country require that you receive the best medical care possible. So even if you don’t get the experimental treatment, you still receive excellent medical care available for your particular condition.
Can I receive treatment without knowing about it?
No. The law requires that you give “informed consent” to anything medical that is done.
Can I quit?
Yes. You can resign from a study at any time, without prejudice. Obviously, if too many people resign from a study, it can’t adequately test a new treatment. If you resign, you will be asked why you want to leave the study.
Do I have to give up my doctor?
No. Your regular doctor will still look after your general health. The people from the clinical trial center will also keep your regular doctor updated.
How long does a study last?
It varies from study to study. A study must last long enough to gather good information, but it is in everyone’s interest to make the study as quick as possible.