Should You participate in a COPD research study?

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Should You Participate in a COPD Research Study?

Are research and trials essential to the end goals of controlling and hopefully finding a cure for COPD?

The answer is yes - BUT are they right for each individual.

Since no trial is completely risk free, the decision to participate must be carefully weighed.

As you evaluate whether you should participate in a particular trial, you should look carefully at your motivation.

Are the possible financial savings with free meds and/or procedures the main reason?
Are you doing it for financial gain, in the case where the trial pays for participation?
Are you hoping for better medicines or procedures?
Are you reaching out in desperation - hoping for that "magic bullet"?
Are you doing it for the good of all COPDers?

Is the trial right for you?

Evaluate your current medical condition.
Evaluate your current treatment plan, especially its effectiveness.
What are your priorities as it pertains to dealing with your COPD.
Are there other alternative treatments that can be pursued?
What is the reputation of the group conducting the study?
What is the current status of the trial you are looking at?
A phase 3 trial is much more likely to be successful, and with less risk, than a phase 1 trial.

Each phase is designed to answer a separate research question.

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Will you be able to continue with your current treatment plan, or will you be on a totally new regime?

What are the risks (both physically and emotionally)? Are you ready to accept a rejection of your application or of being in a placebo group?

As you talk with the researchers or their representatives, remember that unlike your regular doctor whose sole purpose is helping you control COPD, the medical researcher's goal is to ensure the scientific and ethical integrity of a medical experiment. Also, be looking for conflict of interest issues with a research team. Remember that the researchers spend a great deal of time and effort which they should be compensated for, however, as has been written up in the past, some have patents or are major stock holders which creates a monetary motivation as well. In the past, there have been accusations of ethical misconduct centering around these issues. If recruiters are used, their main mission is to provide patients for the study. That goal is not necessarily in your best interest.

Do not assume that a particular study is going to be good for you. There may be tests or procedures that you normally would refuse, if you thought about it. If you do enroll in a study, how will the study requirements differ from what you are presently doing. Weigh the potential for gaining major improvements against the risk of potential side effects.

Though not too common, be sure to check out the financial responsibilities that you might incur. Some tests might not be covered within the study. Your insurance may or may not cover them.

As you evaluate the reputation of the organization conducting the study, pay particular attention to the issue of privacy, as well as security of the information. You do not want your information made available to others without your expressed approval each time.

If you are contacted (or volunteer) directly by a study, consider getting a second opinion. Your PCP or Pulmonologist would be a good place to start, since they are the most knowledgeable of your condition, and should have your best interest in mind.

Several years ago, as I evaluated a particular study, my PCP recommended against it. As he pointed out, with my low numbers, there was little room for any additional loss of capability. A person with an FEV1 in the 50's can lose 5 points and not be affected greatly but, with my low starting numbers, if I lost the same 5 points, or even less, it would have a major impact. Since I was doing very well, even with my low numbers, he felt the risk of losing was not worth the potential gain of that early study.

Sadly, that was the case for one, a very special COPD friend, who was so excited to be a participant. She worked so hard to be physically ready. She and I were looking at the same research study, though in different parts of the country. She lost that little bit from her already low numbers, and was unable to recover completely from the study and subsequent medical issues.

All trials should be looked at with caution.

cg