Part 2 of 3: Alternative Therapies for COPD

3 Key Questions to Ask Yourself Before Enrolling in Research

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RECAP: This is Part 2 of a series that is intended to help patients and their families make educated and informed decisions about how to approach alternative therapies for COPD.  In the series, we will describe what questions you should ask and who you should ask them of. We’ll also discuss how patients and families can sort through the enormous volume of online material about new therapies, including research studies, and how to evaluate researchers and clinicians who provide yet unproven therapies.  In Part 1, we discussed what the term “FDA Approval” means and described the four phases of a clinical research trial.  In Part 2, we will provide information about how patients can participate in clinical research studies and what should be considered prior to enrolling in research.

Without research, science has no hope of advance.  As a researcher myself, I cannot stress the importance of participating in research.  Myths abound about research, and for good reason.  There are many misconceptions about research and unfortunately, many patients with incurable diseases, such as COPD, feel that participating in a research study is their “last hope”.  Although patients with all stages and types of COPD can (and, if interested, SHOULD!) participate in clinical research, no one should do so without first learning about the process of how research is conducted and regulated. 

Keep in mind a few key concepts right off the bat:

  1. It should not cost you any money to participate in research.  Any ‘experimental’ therapy that requires you to pay money is not government regulated research, and therefore is unlikely to be legitimate.  Many research studies provide the participant with financial stipends, travel reimbursement, and medical expenses to participants.  Under no circumstances should participants PAY to be involved in research.
  1. Research that involves human subjects must be overseen by a regulatory body, often called an Institutional Review Board.  This board (often called an ‘IRB’) is charged with ensuring that researchers follow the appropriate ethical and regulatory procedures.  All research studies should provide you information on how to contact the IRB and ask questions as necessary.  If the research is not overseen by such a board, it is not legitimate research.
  1. ALL research has risks.  Any researcher claiming that a study has “no” risk, is not accurately reflecting the research.  While some research has “minimal risk”, for example, filling out a survey, there is still a risk of your personal information being disseminated without your knowledge.  While many research studies have minimal risk to participants, no researcher should ever tell a participant that there are “no” risks.

So, how can you figure out if the research is legitimate? Here are 3 important questions to ask yourself before enrolling in a clinical trial research study:

  1. Is it listed on www.clinicaltrials.gov Although a relatively new system, ClinicalTrials.gov lists all human clinical trials research.  If the study you are thinking about participating in is not listed on this website, you should contact the sponsoring institution’s IRB to seek out more information about the study.
  2. Who is the researcher?  You should always be given the name of the head researcher prior to enrolling in a research study.  A quick way to find out if a researcher has a strong track record of research is to type their name into Google Scholar. Google Scholar provides a listing of peer-reviewed, published research articles that is searchable by researcher, title or topic.  This is a quick way to do a ‘background check’ on the research investigator and/or the research team.  Experienced researchers will often have several publications in Google Scholar.  Younger researchers will usually be working with more experienced ones, and this quick search can help you to learn more about the outcomes of the research the team is conducting.
  1. Who is the funder?  Researchers often apply for grants for organizations to get money to pay for their research.  It is a very competitive process, and so when researchers have funding from reputable organizations, you can feel reassured that the appropriate regulations are in place.   The best way to learn about the funder is to look at their websites to review how much research they have sponsored in the past and to read about their track record of conducting research studies that lead to publications (which are usually listed in Google Scholar.) Some examples of strong funders of COPD research include the National Institute of Health, the American College of Chest Physicians, the American Thoracic Society, the American Lung Society, and many others.

Participating in research is a big decision, and it’s important to make sure you get the facts.  The research assistants should go through a formal consent process with you and you should be able to ask as many questions as you need to prior to enrolling in a study.  No matter how simple or how involved a research study is, these principles should be in the back of your mind prior to signing consent.  After all, gathering information prior to enrollment in research is never a bad idea.

​This article just scratches the surface of the things research participants should consider--be sure to read the Key Articles listed below for more information about research and clinical trials, whether you are looking at research trials for cancer, COPD, or other diseases.   

Be sure to check out Part 3: New advances in COPD treatment

Part 1: Seeking Alternative Therapies for COPD? Get the facts!

Part 2:  How can I participate in a clinical research study and what should I know before starting? 

Part 3: What are some examples of new therapies and ongoing research studies for patients with COPD?

 

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