So you want to participate in research
By DrRich
In the old days (20 years ago) nobody was anxious to participate in medical research. The prevailing attitude was: Why would anybody volunteer to be a guinea pig?
But times change. Now, participating in clinical trials is widely viewed as the best way to receive the latest in therapeutic miracles. Some patients actually get angry if doctors offer them only "approved" therapies. Participating in research is considered by many to be a right instead of a burden, and more and more people with medical problems are actively seeking research studies in which to participate.
In this article, we will discuss some of the factors you should consider if you think you may want to participate in a medical research study, and point you to several links that aim to match willing patients with medical investigators desperately seeking research subjects.
Should you participate in research?
Whether you "should" participate in a medical research study is a question that must be answered only by you. But to answer that question, you will need to take several factors into consideration.
What do you stand to gain?
Let's be honest here. There 's a good chance that you wouldn't be anxious to participate in research if such participation did not offer some potential benefit to you. In most cases, the hoped-for benefit is the possibility of having access to a new drug, medical device, or medical procedure that would be unavailable outside of the research setting. Wanting such a benefit is perfectly acceptable, normal, and even admirable.
Before signing on the dotted line, it is important to assess the magnitude of the benefit you can realistically expect from a medical research study. If you have some incurable disease for which currently available therapy is ineffective, and if the research study is offering to test a new therapy that has some reasonable chance of success, then you stand to gain (potentially) quite a bit from participating in that research. And there are indeed plenty of such studies around.
On the other hand, if you have a medical problem for which adequate therapy already exists (such as hypertension or high cholesterol,) then a) it is relatively unlikely that the research therapy will be substantially better than the currently available non-research therapy, b) the research therapy may even be worse than currently available therapy, c) by participating in the research you are potentially exposing yourself to unexplored side effects of a new treatment, and d) if the new therapy is worse than the routine therapy, then by participating you may suffer the consequences of being "undertreated" for your medical condition for whatever time is involved in the research.
The bottom line: The odds that participating in the research will benefit you are related to how good current therapy is. If current therapy is quite good, the research therapy is relatively unlikely to be significantly "better," and vice versa.
What does "society" stand to gain?
Altruism is another legitimate and admirable reason for participating in medical research. Even if you personally don't stand to gain much from your participation, by participating you may benefit other patients in the future.
If this is your reason for participating in research, then you should assess just how much benefit the research is likely to offer to society. If the research is testing a new treatment for a currently incurable disease, for instance, then your participation may be a small step toward a cure - society stands to gain. On the other hand, if (as is often the case) the research is testing a "me too" drug - a drug that is quite similar to drugs already on the market (such as a new statin or a new beta blocker) - then even if the new drug turns out to work well, society really hasn't gained much (although the drug manufacturer has.) There's nothing wrong with a new "me too" drug - competition between pharmaceutical companies is inherently a good thing. It's just that your contribution to mankind in participating in such a study seems quite limited - and if that's your reason for participating, think again.
Who is sponsoring the research?
If the sponsor is a drug company or a biotech company, then the purpose of the research is generally to validate a new treatment or test for the purpose of gaining FDA approval to go to market. If the research is sponsored by the NIH or a professional society (such as the American Heart Association) then the research is more likely to explore a more basic or general research question - such as, Is bypass surgery better or worse than angioplasty?
There is nothing wrong with either of these research approaches - both are important, and both yield important results every day. But knowing the sponsor of the research can help you focus on the kind of research question being explored, and help you decide whether participating in such a study is right for you.
Who is the clinical investigator, and what is his/her relationship the sponsor?
The clinical investigator is the doctor who explains the research to you, signs you up for it, and directs your participation in the study.
While the clinical investigator may also function as your own doctor, be aware that this creates an inherent conflict. Your doctor's primary allegiance is to your personal welfare, whereas the clinical investigator's primary allegiance is to the integrity of the research study. There will be times when medical care yields two possible paths of action: While both are probably OK, Path A would be somewhat better for you, while Path B would be better for the research study. If your doctor is also the clinical investigator, which path will he/she recommend?
Is your doctor being paid a bounty by the sponsor to "sign you up" for the research? This arrangement is becoming exceedingly common - in fact, many doctors are supplementing their incomes today (at a time when medical incomes are falling) by becoming clinical investigators for "contract research organizations." (Essentially, contract research organizations are companies that contract with drug companies to find patients to enroll in their research studies. These are the unnamed companies that advertise on the radio to get you to call a number about a new treatment for high cholesterol or urinary incontinence.) Doctors can make from hundreds to thousands of dollars for each patient they enroll, and often the biggest enrollers get their name on a research paper (even though their intellectual contributions to the study are nil.) This practice, which creates obvious conflicts of interest, is becoming common even in university hospital settings.
What is your personal risk?
Be absolutely sure you learn as much as possible about the risks you are accepting by participating in the research study. What is known about the procedure/drug/device being studied? What adverse events have occurred during prior animal testing, and during earlier trials in humans? What side effects are known to occur with similar therapies? What would be the consequences of foregoing currently available treatments long enough to test this new therapy - a therapy that might not work?
Will you be "randomized?"
Increasingly commonly, clinical research today involves the process of randomization. That is, research participants are randomly chosen to receive either the research therapy, or the "control" therapy. Control therapy usually consists of either a placebo (a sugar pill,) or of the therapy most commonly used in clinical practice. Most often, neither you nor your doctor will be aware of whether you are in the "treatment group" or the "control group" until the study is over. Randomization is extremely important, in many kinds of research studies, to guarantee that the results measure the true worth of the experimental treatment. But you need to be clear on whether you "will" be getting the research treatment, or whether you only "might" be getting the research treatment. It is a factor you need to consider prior to agreeing to participate.
The fact that many research studies are randomized is a clear indication of the primary goal of these studies. The goal is NOT to benefit the individuals participating in the study. The goal is to measure whether the treatment under investigation actually works. What happens to individual participants is immaterial to this goal.
What happens to you when the research is completed?
If the new research study is effective, and you receive substantial benefit from your participation in the trial, then what happens during the time that the research study is completed but the new therapy has not yet been approved by the FDA? Will the sponsor continue to make the new treatment available to you, or will you have to go back to the less effective approved treatments?
Do you truly understand every aspect of the research?
Before you participate in a medical research study, you will be presented with a document called the "informed consent form." The informed consent form, mandated by federal law and overseen locally by a hospital committee called the Institutional Review Board, is supposed to lay out ALL the information you will need to make an informed decision as to whether you ought to participate in the research study. This document is supposed to be supplemented by a personal visitation by the clinical investigator, in which he/she spends whatever time is needed to be absolutely sure that you understand all aspects of the research study.
Needless to say, many informed consent forms are written in a combination of medical and legal jargon that would be difficult for anyone without a joint MD/JD to decipher, and the one-on-one with the clinical investigator often takes on the hurried tones common to most doctor-patient encounters these days.
Nonetheless, before you donate your body to medical science, you need to take whatever time is necessary - and insist that the clinical investigator do the same - to fully understand every aspect of the research. If you are unable to do this, then you should re-think long and hard about whether you really want to sign up.
Where to find suitable research studies
Thanks to the miracle of modern communication technology, there's a way to match willing research participants with investigators desperately seeking subjects. If you're interested in becoming a research subject, follow these links to see which projects are recruiting.
Clinical
research studies sponsored by the National Heart, Lung and Blood Institute
These ongoing clinical trials are seeking patients. The site gives a
contact person and some background information for each open study.
ClinicalTrials.gov
ClinicalTrials.gov is a search engine, sponsored by the National
Institutes of Health, that matches patients who want to participate in a
research trial, with ongoing trials that meet their needs. The search
engine finds ongoing clinical trials that match your search criteria.
CenterWatch
CenterWatch is a clinical trials listing service that attempts to match
interested participants with over 41,000 clinical research studies. This
site even offers a notification service, so that if a new trial begins that
meets your needs, you will be notified of it.
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