One of the advantages of living in a large metropolitan area such as New York City is that there are many more options in terms of things to do and experience that are not as readily available to people who live outside such areas.   This is particularly true when it comes to access to cutting edge medical care.

New York City is home to some of the finest universities, medical schools, and hospitals in the United States.   As a result, people who live in and around New York City have access to institutions and medical professionals who possess a wealth of experience and knowledge about the latest advances in medical science that they can bring to bear to quickly and accurately diagnose and treat what ails us.

It is important to keep in mind that the practice of medicine is dynamic and constantly evolving.  In large part, this is due to the innovative and dedicated work that pharmaceutical companies and medical researchers and institutions are undertaking in order to better understand how to treat the various medical conditions that the population, as a whole, presents.

This is where clinical trials come into play.  Clinical trials are a necessary step in the development of a given drug or device, because this is where the drug or device is finally evaluated in the target population – people who actually suffer from the disorder in question.  Up to this point, the drug or device will have generally only been studied in the laboratory or in animals.  While the data derived from these experiments are extremely useful in making predictions as to the potential safety and effectiveness of the drug or device in question, ultimately, the drug or device must be evaluated in people, as people will ultimately be the ones using the drug or device.

If the results of the clinical trials appear to offer compelling evidence as to the relative safety and effectiveness of the drug or device in question, medical researchers, pharmaceutical and biotech companies can submit their data to the Food and Drug Administration (FDA) for consideration of approval of the drug or device to treat the disorder in question.  This is essential, because it is illegal for a pharmaceutical or biotech company to make a claim (advertise) that a given drug is safer or as or more effective at treating the disorder in question, if the FDA has not approved it to make such a claim.

So…  Taking into account everything from above, why do people agree to participate in a clinical trial and what are some of the potential pros and cons of doing so?

PROs:

• Access to a new and potentially more effective and/or safer treatment than is currently available.
• Access to a treatment approach with fewer or less severe side effects than is currently available.
• Help others by helping pharmaceutical companies obtain the data they need in order to obtain approval for the drug or device in question.
• Even if the drug or device fails to do what it was hypothesized to do, it provides important information that can guide researchers to other potentially more rewarding approaches to the treatment of the condition under study.
• Commonly, the cost of the drug/device under study, as well as the fees for the medical professionals that see you, as well as all tests and procedures that are performed are provided free of charge. No insurance is necessary.  This is particularly important for those people who feel they cannot afford to pay for the medical care they know they need.
• Generally, research sites will reimburse participants for reasonable travel-related expenses so even the cost of getting to and from the site may be provided.
• Frequently, research sites will provide participants with a modest stipend (i.e., money) as a further benefit for participating in their trials.

CONs:

• Fear of the unknown.
• Lack of understanding of what’s involved.
• Placebo arm: In most trials, not everyone gets the active drug/device under evaluation.  Some get a placebo or inactive comparator (e.g., sugar pill).  People volunteering to participate in a clinical trial are generally doing so in order to derive improvement of their condition.  If the probability of receiving the active treatment is not high, some people may elect not to participate.  To address this concern, many current clinical trials provide a higher probability of receiving the active treatment than placebo.
• Potential for experiencing unwanted adverse reactions or side effects.
• Travel: Sometimes the research site is either a long distance from where the person lives (i.e., time) or getting there poses significant challenges (means of transportation).
• Inconvenience due to work or other common daily commitments.

There are many ways to find out information about the types of clinical trials being conducted at research facilities near you.  One of the best sources is the web.  Two frequently accessed general sites are www.clinicaltrials.gov and www.CenterWatch.com.  You can also do a more focused search using such general keywords as www.clinicaltrialsnyc.com or www.nyclinicaltrials.com.  You can even refine your search to a specific medical condition or geographic location such as www.clinicalresearchstudiesbrooklyn.com.

Whatever you ultimately do or don’t do, the choice is yours and yours alone.  When considering whether or not to participate, remember to consult you physician.