While a clinical trial can provide doctors with better ways to prevent, detect, diagnose and treat illnesses, can they also provide new hope for patients with COPD? And what about the risks?
Why is a Clinical Trial Performed?
Many clinical trials are conducted to determine the safety and efficacy of a new drug, medical device or treatment, however, there are also other reasons why they are performed. Some compare existing, approved treatments (standard treatments) to determine which is more effective. Some examine different ways of delivering the standard treatment to help make it easier to use or to reduce bothersome side effects. Some help to determine if the treatment is safe to use in an entirely different population, such as in children.
Clinical trials are conducted under the intense scrutiny of the Food and Drug Administration (FDA). The FDA sets forth rules and guidelines for clinical trials to make sure that the people who are being studied are as safe as they can possibly be.
Are There Different Types of Clinical Trials?
There are several different types of clinical trials including:
- Prevention trials
- Diagnostic trials
- Screening trials
- Treatment trials
- Quality of life trials
A clinical trial is conducted according to a specific protocol for each trial. For example, in a medical device study for emphysema, participants may qualify for the study only if they are in a particular age group, have not smoked for a certain length of time, are willing to abstain from smoking for the duration of the trial and have emphysema located in only one particular area of the lung. Each person who participates in a clinical trial must agree, and adhere to, the set protocol in order to participate in the trial.
Are There Different Phases of Clinical Trials?
Just as there are different types of clinical trials, so are there different phases. Each phase has a unique purpose and strives to answer a specific question. The phases of clinical trials are as follows:
- Phase I trials
- Phase II trials
- Phase III trials
- Phase IV trials
Who Can Participate in a Clinical Trial and Why?
Because it is important that new treatment strategies are safe and effective for everyone, the FDA tries to ensure that all groups of people are included in clinical trials, including those of different age groups, races, ethnicities and gender. And, just as there are different groups of people who are being studied in clinical trials, there are different reasons why people want to participate in them. Perhaps all other treatment options have been exhausted, or the individual cannot tolerate the untoward side effects of the standard treatment. Whatever the reason, it is important for each individual to weigh the potential benefits against the possible risks associated with the trial.
What are the Benefits of Participating in a Clinical Trial?
Clinical trials are meant to help people. Those who participate in them generally do so because the benefits outweigh the risks. Participating in a clinical trial can be very rewarding. Those who otherwise don't have health insurance or quality medical care, can now have access to expert medical care for the duration of the trial. Those who have not previously participated in their own health care, can now get actively involved. Participating in a clinical trial not only gives you access to new research treatment, but it helps you help others by contributing to medical research.
What Risks are Involved in a Clinical Trial?
Generally, all clinical trials carry with them a certain level of risk. Some are known, some are not. Possible risks include, but are not limited to the following:
- The treatment causes unpleasant, serious or even life-threatening side effects.
- The treatment doesn't work for the participant.
- The trial involves much more time and attention than the current treatment.
- Participants may be required to stay in a hospital, which has it's own set of risks.
- If treatment is beneficial and the treatment stops at the end of the clinical trial, the sponsor of the trial may not continue to provide treatment to the participant.
Is a Clinical Trial Safe?
Although federal regulations are in place to protect the public against unreasonable risks associated with clinical trials, there is always a certain level of uncertainty when it comes to medical science. The FDA, therefore, requires those who conduct research studies to provide participants with complete and accurate information regarding the prospective trial. Furthermore, each participant must give (and sign) an informed consent before the trial is started.
How Can I Find a Clinical Trial For COPD in My Area?
To find out about current COPD clinical trials visit ClinicalTrials.gov.. Here you will find an online database of the most current clinical research being done on human volunteers. ClinicalTrials.gov is updated frequently and provides a wealth of information about each trial's purpose, eligibility criteria, location and contact information.
Final Word on COPD Clinical Trials
COPD clinical trials exist because somewhere, in the heart of every researcher, lies the hope for a cure, less symptoms and/or better quality of life. Hope that, for people with COPD, is often lost upon receiving a diagnosis. It is important to remember though, that without hope, we have nothing. While it is true that clinical trials can provide new hope for those with COPD, with new hope comes the possibility of bitter disappointment. Keeping your expectations low and your hopes high, will allow you enter into a clinical trial with a positive attitude and an open mind, which is necessary for keeping that glimmer of hope in your heart.
Source:
U.S. Food and Drug Administration.Basic Questions and Answers about Clinical Trials. http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html
