All medication prescribed to patients in the United States is approved by the Center for Drug Evaluation and Research (CDER), a branch of the U.S. Food and Drug Administration (FDA). This program acts as a watchdog for all genetic and biological therapeutic drugs being tested throughout the country, ensuring that only safe and effective ones are administered to the general public.

Contrary to the name, however, the CDER doesn’t spend a lot of time researching new drugs. Instead, the organization receives applications from drug makers and evaluates their efficacy through a four-phase approval process. Once the phases are complete, the drug is considered “FDA approved” and is distributed to pharmacies throughout the country. If the side-effects or risks posed by the drug ever outweigh the benefits, the FDA may recall a drug that has already been distributed.

As a patient, this drug approval process provides you with a unique opportunity called a clinical trial. These clinical trials play a crucial role in evaluating the safety and effectiveness of a drug and may be the perfect opportunity for you to seek relief from your respiratory symptoms — but they’re not for everyone.

In the following sections, we’ll take a look at what clinical trials are, how they work, and why you may want to consider participating in one. As always, if you have any questions about your current treatment plan, clinical trials, or any other COPD-related concern, be sure to consult your doctor as soon as possible.

What is Clinical Research?

In medical terms, the word “clinical” refers to the observation and treatment of real patients as opposed to theoretical or laboratory studies. They act as a sort of real world experiment for medication without the risks associated with immediately releasing it to the public. Generally, clinical research is divided into two categories: observational studies and clinical trials.

Observational Studies

During an observational study, researchers observe people in a normal setting. Through medical exams, questionnaires or other tests, they can help reveal common health trends throughout a community and provide new opportunities for clinical trials.

Clinical Trials

Clinical trials are similar to observational studies, but instead of taking a hands-off approach, they aim to test a specific medical, surgical, or behavioral intervention. While a drug may work in theory or in practice in a petri dish or on animals, a clinical trial allows researchers to test their effects on actual patients. Because clinical trials are completed by sponsors and not the FDA, there are certain criteria that need to be met before a drug can be tested and drug sponsors need to submit an Investigational New Drug (IND) application that outlines the results of their testing, the composition of the drug, and a plan for its development — this is called the pre-clinical stage.

All clinical trials have a purpose which can be part of one of the following categories:

Diagnostic - finding new procedures, techniques, and methods for diagnosing diseases more effectively or sooner.

Screening - testing different methods for improving screening procedures that could reveal signs of a disease.

Prevention - examining vaccines, vitamins, medicines, minerals, or lifestyle changes that could prevent the development or recurrence of disease.

Treatment - testing new drugs, combinations of drugs, surgery, or therapy that reduces the effects of a disease.

Supportive Care - Evaluating the effectiveness of procedures used to increase the comfort and quality of life of a patient.

Health Services - Examines the financial aspects of health care, access to care, organization, and delivery methods.

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The Four Phases of a Clinical Trial

Phase 1 

20-80 participants

The first phase of the clinical trial process is focused on safety. Most drugs, regardless of how effective they are, have some form of negative side effect associated with them. The goal of the first phase is to test the way the drug is metabolized and processed by the body. Typically, phase 1 is performed on healthy recipients without an illness. 

Phase 2

100’s of participants

Unlike phase 1, phase 2 is all about effectiveness. As a result, this stage usually requires participants with a condition the researchers are trying to treat. Researchers may also compare the effects of these drugs to other similar drugs that are being used to treat their condition. Phase 2 won’t begin until the perceived benefits are greater than the risks uncovered in phase 1.    

Phase 3

1000’s of participants

Phase 3 studies both safety and efficacy further. Researchers may study different demographics, dosages, or using it in combination with other drugs. Participants may be divided into different groups so the results can be compared. Oftentimes, phase 3 clinical trials can last several years depending on the type of drug that’s being studied.

Phase 4 

Post-approval risk assessment   

At phase 4, the drug has been approved by the FDA and doctors can begin administering it to patients. However, in certain cases, the sponsor may need to continue studying the effects of the drug. This is especially the case if the sponsor wants to be able to sell the medication for a new purpose such as treating a different disease.

The Clinical Trial Process

For many people, the most intimidating part of clinical trials is the process. First and foremost, you should know that you will never be a part of a clinical trial without your knowledge. In order to be a part of one, you’ll need to first sign an informed consent form. This differs from a regular consent form in the following ways.

• Participants must be given the necessary information to make an informed decision about their involvement in the trial.
• Participants must be allotted an adequate amount of time to discuss the clinical trial with friends and family.
• Researchers must be open and honest about all questions regarding the clinical investigation.
• Researchers continue to provide information about the trial as it progresses. 

After meeting with the staff and signing an informed consent form, you will be screened to ensure you qualify for the trial. This is done through what’s called a “baseline” visit where researchers will conduct both physical and cognitive tests.

Once all the consent and qualification processes have been completed, you will be assigned to a control group and given specific instructions like when you need to come in for a checkup. If there are any forms that you need to fill out daily or weekly, they will go over this with you to ensure you understand what needs to be done. Note that you should continue to visit your regular primary care physician throughout this process and keep them updated with information about the clinical trial.

Who Can Participate?

Because clinical trials are used to study a specific group of people, it’s not unusual for an application to be declined. Criteria will differ from study to study, however, the age of the patient, disease stage, gender, genetic profile, and family history could all play a role. Your ability to participate could also be affected by other medications you are currently taking that may interfere with the study.

Diversity of test subjects is very important when conducting clinical trials. The objective is to find drugs that are effective for a wide group of people, so the more people that are involved, the better idea researchers will get of the potential risks and benefits. If you think you’ll get turned down because of a specific condition you have or your age, it’s best to contact them anyways because you may be just the person they’re looking for.

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Benefits of Clinical Trials

For some COPD patients, clinical trials are a great option, allowing them to receive treatment for their condition outside the traditional means of doing so. However, for others, it may add an extra burden to their healthcare routine that’s unwanted and unneeded. It’s important to take your time and determine if it’s something worth pursuing. 

Access to New Medication

Possibly the most common reason people join a clinical trial is that they get access to medication that’s not yet available to the general public. This is especially beneficial to people who don’t like the side-effects of medication they’re currently taking or they’re simply interested in trying something new. 

Assisting in Research

Another common reason for participating in clinical trials is to assist in the process of researching new solutions for your disease. While it may sound like you’re playing a small role, researchers would not be able to test their medication without the help of people who have the condition they’re trying to treat.

Back Out at Any Time

One common misconception about clinical trials is that once you sign up, you won’t be able to back out. Fortunately, this is not the case.

Anyone who signs up for a clinical trial can back out at any time and for any reason. It is, however, recommended that you notify the research company of your decision and consult with your doctor immediately to get back on your regular treatment plan.

Potentially Reduced Costs

While you or your insurance company will still need to pay for the medication you receive, many costs associated with clinical trials like checkups and evaluations are paid for by the company that is performing the test. So, you may be getting some additional checkups or medical services for free that you would normally be paying for with your primary care physician.

Disadvantages of Clinical Trials

Medication is Not Approved by FDA

While there are many benefits to being part of a clinical trial, there are several downsides as well, one of which is that the drug likely hasn’t been approved by the FDA yet. If you refer back to the list of phases above, you’ll see that only one phase, the 4th, is FDA approved. So, if you’re part of a clinical trial that’s in the first, second, or third phase, you’ll be using medication that hasn’t been fully tested yet.

Fortunately, the FDA maintains regulations for clinical trials that protect patients’ safety and security, you can view the full list of regulations on their website. In short, however, these documents require researchers to take a number of precautions when it comes to your safety and notify you about every detail of the procedure. 

Frequent Checkups 

Another thing that may be seen as a disadvantage to clinical trials is that you have more frequent checkups and more responsibilities. During a clinical trial you may be required to go to the testing center weekly to check your progress and document the effect of the medication on your body. Additionally, you may be asked to fill out forms or questionnaires that ask about your symptoms. All of this takes extra time, so if your goal is to save time, you may want to avoid clinical trials.

Placebo-Controlled Studies

Last, but certainly not least, placebo-controlled studies may be seen as a disadvantage to clinical studies depending on what your goals are.

When researchers start a clinical trial, they want to do everything they possibly can to ensure the results of the study are accurate and have a very low margin of error. As a result, they may use something called a “placebo” or an inactive substance that’s designed to look exactly like the actual medication. Oftentimes, even the person administering the medication doesn’t know whether the medication is real or a placebo; this is known as a double-blind, placebo-controlled clinical trial.

Placebos are used to account for the “placebo effect.” In other words, if you tell someone that they’re receiving medication for their condition, they may perceive that they benefited from the drug even if there was no actual benefit. When researchers divided test subjects into placebo and non-placebo groups, it allows them to account for this psychological effect.

Generally, placebos can be seen as a negative because you won’t know whether or not you’re actually receiving treatment for your condition. Although researchers are required to notify you if placebos are a part of the trial, they won’t tell won’t tell you as an individual that you’ll be given placebos.  

Insurance Coverage for Clinical Trials

Fortunately, most health insurance companies are required to offer coverage for clinical trials under federal law. However, the coverage you receive will depends on three things:

• You must be approved and eligible for the trial
• The trial must be approved
• Out-of-network doctors or hospitals will not be covered unless otherwise stated in your plan
  
  

Approved Clinical Trials

An approved clinical trial is one that includes the following:

• It tests ways to treat, detect, or prevent life-threatening conditions
• It’s been approved by the FDA by submitting an IND application is not required to submit one.
  
  

What Costs are Covered?

Some of the costs your insurance will cover include:

• Lab tests
• Office visits
• Procedures and services needed in trial
• Supportive care drugs
  
  

Costs that are typically not covered include:

• Data collection used for the trial
• The cost of the procedure or treatment studied by the clinical trial

Before you commit to a clinical trial it’s important that you understand what your insurance does and does not cover. If the research team has out-of-network doctors or facilities, you may be liable for these costs. Costs such as data collection and treatment may be covered by the research company, however, unless specifically stated, it’s best to assume they aren’t.
  

Current Clinical Trials for COPD

If you’re a patient who is currently undergoing treatment for COPD, you may want to consider being part of a clinical trial. Clinical trials for COPD help researchers understand better ways to prevent, screen for, and treat symptoms of the disease. Remember, however, that your ability to participate in a trial will depend on your current health condition, age, gender, ethnic profile, and a variety of other conditions. What’s more, there may or may not be a clinical trial in your area for you to apply to.

COPD Patient-Powered Research Network

The COPD PPRN is a network of 75,000 COPD patients that’s designed to connect them with researchers who perform clinical trials. According to the COPD Foundation, while COPD is the 3rd leading cause of death, there are only 780 clinical trials, a small fraction of the nearly 41,000 trials taking place for cancer research. The COPD PPRN is not a clinical trial in and of itself, but it is a directory that can provide you with more information on finding local clinical trials for COPD. 

ACRC Clinical Trials for COPD

The Airways Clinical Research Centers (ACRC) is run by the American Lung Association and is dedicated to researching both asthma and COPD. Around 6,900 patients have participated in clinical trials in 15 clinical research centers throughout the country. There are several clinical trials currently underway including an asthma BMI baseline study, anxiety andd COPD evaluation, losartan effects, and much more. You can view a full list of current studies and their stages here. 

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Conclusion

Clinical trials are a crucial component of medical research. They afford researchers all over the country an opportunity to test the safety and efficacy of their medication while allowing patients to make a difference as well. There are many benefits to being a part of a clinical trial, but there are also several disadvantages. 

If being a part of a clinical trial interests you, it’s best to start by speaking with your doctor and signing up for one of the research networks listed above. If you decide it’s not for you, there are still a number of ways you can get involved like attending events, providing health information, or recruiting friends to a research program. Click the links below for more information on clinical trials for COPD.

Finding a Clinical Trial

COPD Patient-Powered Research Network

Airways Clinical Research Centers (ACRC)

CenterWatch COPD Clinical Trials

Other Resources

Questions to Ask Your Doctor about Clinical Trials

Myths about clinical trials

Medicare Clinical Trial Policies