Finding Clinical Trials
 Introduction
With 6,000 protocols comprising approximately 80,000 government- and industry-sponsored clinical trials conducted in the United States each year, there is a good chance that you will find trials for new treatments targeting your illness. There is also a good chance that some clinical trials may find you – through notices in your doctor’s office to radio, television and newspaper advertisements.
Only 10 years ago, it was very difficult for patients to actively identify clinical trials. The vast majority of clinical trials were done in academic medical centers – many of them within major metropolitan areas. Unless your physician was close in proximity and affiliated with an academic medical center, it is unlikely that you would have found a clinical trial opportunity.
Today, there are numerous resources in print and online for professionals and patients to use. And with more clinical trials being conducted by independent, community-based physicians, there is a far greater chance that your own primary and specialty care physicians and nurses will be able to assist you in identifying clinical trials that you may be right for. Your family and friends may be able to assist you in conducting a broad search, and then narrowing down your options to a few targeted opportunities.
Remember that when you begin your search, your goal is to be as thorough and comprehensive as possible. Every piece of information that you collect and every individual you speak with may assist you in tracking down a clinical trial that could hold some potential for you. Once you have isolated a few clinical trials whose posted inclusion and exclusion criteria you meet, then you – and your support network – can begin to scrutinize whether any of these trials might be a good match for you.
Search Strategies for Finding Trials
Today, two out of three patients refer themselves to clinical trials. There are essentially two ways to find them. One is to search for the trials themselves. The other, perhaps easier, approach is to search for investigational drugs and then determine where they are being tested. A few health web sites allow you to conduct both types of searches at the same time.
Regardless of your approach, there are numerous people, organizations and publications available to assist you. But you have to know whom to ask and where to look. Here are a few good bets:
Health professionals. Primary and specialty care physicians and nurses, in particular, may have access to some specialized (and expensive) medical journals and online databases where clinical trials, and study drugs, are routinely discussed topics. These professionals are also worth consulting after you’ve found some initial sources of information. Not all medical publications and web sites provide accurate information. Health professionals can generally help you narrow down your list. They’re also invaluable when it comes to translating medical jargon into everyday language and to finding sources that may assist in extending your search.
Libraries. Public libraries, college and university libraries, pharmacy libraries and hospital medical libraries are all terrific sources of information on trials and investigational drugs. Many libraries subscribe to the “Gale Group’s Health & Wellness Resource Center” database, which has journal articles on study drugs and how they’re faring in clinical trials. University libraries often subscribe to Dialog, a leading provider of online health information. The libraries of hospitals and universities with an affiliated medical center are both particularly good sources of print editions of medical journals that carry news of drugs under development and the latest study results. Hospital libraries tend also to be good places to find trial-listing pamphlets for big research centers like the Mayo Clinic and Johns Hopkins.
But medical libraries aren’t always accessible to the public. If they are, they may be open at odd hours and staffed by volunteers rather than a trained medical librarian. The ability to order full-text medical articles from services like MEDLINE (for about $8 to $10) may be limited to staff physicians. But for anyone without a home computer, public libraries generally provide free access to all sorts of helpful online databases, medical journals, major newspapers and web sites (discussed below). Those that have a research librarian on staff will even do the search for you, but there may be a fee.
Online databases. Some great databases, such as those offered by The Dialog Corporation and The Gale Group, are available only by subscription and are out of the price range of most home computer users. But there are many others available, for free, over the public access Internet. These include databases offered by CenterWatch, the National Library of Medicine, pharmaceutical companies and professional societies. All are discussed in more detail below.
Web sites. The web has become an extremely valuable way to find information about clinical trials. Pharmaceutical companies, professional associations, non-profit organizations and research institutes all provide varying levels of online information about clinical trials and investigational drugs. Many general health web sites also periodically run articles about drugs in development, though the content is of mixed quality and reliability. (See “Most Popular Health Web Sites,” below.) There are more than a dozen web sites that focus on listing clinical trials.
One of the best ways to look for information online is to do a keyword search. Simply enter a search term, like “clinical trial,” to single out documents and materials that contain these specific words. Putting them in quotation marks turns up only entries where two words are found together in a phrase. Try several different forms, and combination, of words – such as “clinical trials,” “clinical research,” “experimental drug,” and “study drugs” – because each search may turn up considerably different results. If you find an article that seems to provide what you’re looking for, cross-reference the researchers listed or drugs used to find other relevant articles. You can also search for drugs and trials by typing in the name of a particular disease, like “mesothelioma” (an incurable cancer).
Research centers. Plan to contact local clinical research centers with expertise in your medical condition. Some of these centers may be advertising for trials that they are currently recruiting for. Research centers that are not actively recruiting for their own trials may know about those going on at other locations near you. Some centers, however, may not be comfortable referring you to their competitors.
You can identify research centers in a variety of ways. Your physician or nurse, and even friends and family, may know of reputable centers. The phone book may also contain listings. Many research centers have their own web sites and, they may be linked to academic health centers if they are an affiliate. The CenterWatch web site (www.centerwatch.com) has an online list of more than 750 research centers that you can search. You may find several centers conducting trials near you for your specific medical condition that you can contact directly by phone or email.
Drug experts. Once you learn the name of a specific investigational drug (or its number, if it’s very new), you might try calling the pharmaceutical company that manufactures it for more information – or an outside pharmacologist with some expertise in the therapeutic area it targets. Some pharmaceutical companies offer toll-free information lines for patients. When perusing through medical journals and newspaper clips about an investigational drug, you should jot down the names of scientists who authored the papers or offered commentary on the drug’s prospects and limitations.
Consider tapping into your support network to help cover all the bases. It also wouldn’t be a bad idea to cultivate a relationship with someone in the media with access to a newswire service. Announcements about new clinical trials, and recent trial results, are routinely posted. Only a fraction of those announcements make it into the editorial section of most local newspapers.
Trial Listings on the Web
One of the top information sources on the Internet is the CenterWatch Clinical Trials Listing Service (www.centerwatch.com), which each year provides an online listing of more than 42,000 clinical trials – industry- and government-sponsored trials – that can be searched by location or disease category. The CenterWatch Patient Notification Service offers patients, their family and friends an opportunity to receive a free and confidential email message every time a new trial is listed on the CenterWatch web site. Patients can sign up for notification at www.centerwatch.com. Several thousand patients are notified each week of new trials listed. CenterWatch also has databases of drugs in clinical trials and clinical trial results. Many professional societies and associations that list trials on their web site draw their information from the CenterWatch databases. In 2002, an estimated 8 million patients and their advocates will refer to CenterWatch clinical trials information on the Internet. The CenterWatch web site has been listing clinical trials since 1995, making it the oldest and largest source for information on industry-sponsored clinical trials.
The National Institutes of Health lists many thousands of government-funded studies through the National Library of Medicine at (www.clinicaltrials.gov). Other web sites offering listings of clinical trials include AmericasDoctor (www.americasdoctor.com), Veritas Medicine (www.veritasmedicine.com), Acurian (www.acurian.com), Clinical Trial Directory (www.clinicaltrialdirectory.com), DrugDev 123 (www.drugdev123.com), Drug Study Central (www.drugstudycentral.com), and Pharmaceutical Research Plus (www.clinicaltrials.com). Many web sites tend to list government-funded clinical research studies, some of which are studies that look at tissue samples, treatments already on the market and behavioral programs, so they are not all clinical trials. And some web sites – including Acurian, Veritas Medicine and EmergingMed.com (www.emergingmed.com) – also provide matching services where they can actively recruit you for their clients’ trials. This service may be particularly helpful for patients suffering from severe illnesses for which they do not have time to conduct a search on their own.
Web sites, including Acurian and Veritas Medicine, usually offer online registration for the purpose of pre-screening study subjects for trials and “matching” them with an appropriate clinical trial. Typically, these web sites receive a fee of $300 to more than $1,000 for matching you with a clinical trial sponsored by one of their client companies. It remains to be seen how receptive people are to this approach and how these web sites plan to deal with privacy issues. At this time, the vast majority of people conducting searches on the Internet are not comfortable divulging personal medical information online.
When considering the use of a matching service, remember that these companies receive incentives to enroll you in specific trials, not to provide you with a comprehensive list of trials. As a result, they may match you with a trial that isn’t as good an option as others outside of their listings.
A number of health information sites, including WebMD (www.webmd.com) and TrialsCentral (www.trialscentral.org), offer general information and links for patients seeking clinical trials. Patient support groups also share information about clinical trials over the Internet.
For cancer-related trials, one of the best listings is at PDQ¨ (Physicians Data Query), accessible from the National Cancer Institute’s (NCI’s) web site (www.cancer.gov/cancer_information). You can also go to www.cancer.gov/clinical_trials. The same information, along with personal assistance in searching for an appropriate trial, is available by calling the NCI’s Cancer Information Service at (800) 422-6237. The HopeLink Clinical Trial Service (www.hopelink.com) is networked with more than 20 organizations that offer cancer studies. Recently, HopeLink teamed up with Angel Flight America to offer free, private flights to patients who pre-screen for a clinical trial through their listing service and later wish to participate in the trial. The intent is to make the geographic limitations of getting into trials less of a problem.
If you are seeking studies specific to HIV and AIDS, you might want to start your search with the AIDS Clinical Trials Information Service, accessible by the web (www.actis.org) or by dialing (800) 874-2572. ACRC, a non-profit organization addressing the needs of under-served communities, also has a few gene therapy trials listed at its site (www.acrc.org).
Studies of investigational treatments and vaccines for infectious, immunologic and allergic diseases conducted or supported by the National Institute of Allergy and Infectious Diseases (a branch of the NIH) can be found at the NIAID Clinical Trials Database (www.niaid.nih.gov). The NIH’s Office of Rare Diseases also has links from its site to many different clinical trials databases (visit http://rarediseases.info.nih.gov). Some specialty medical groups and non-profit associations also list trials seeking enrollees on their web site, as do some of the sites sponsored by self-help groups and pharmaceutical companies. We have provided a list of health association web addresses in the appendix.
URAC is a Washington, D.C.-based health accreditation organization, also known as the American Accreditation Healthcare Commission, which measures general health web sites against rigorous standards for quality of information and ethical accountability. Of the 13 health web sites that have received URAC’s seal of approval, five contain helpful information about clinical trials and investigational treatments. URAC-accredited web sites with clinical trials information include InteliHealth (www.intelihealth.com); Laurus Health (VHA) (www.laurushealth.com); Veritas Medicine (www.veritasmedicine.com); WebMD (www.webmd.com); and WellMed (www.wellmed.com). It is important to note that in order to be accredited, a web site must pay several thousand dollars in commissions or fees to URAC. As a result, this list is somewhat biased.
Amgen, a biotechnology company, has devoted an entire section of its web site (www.amgen.com) to clinical trials for medical conditions ranging from recurrent cancer to juvenile rheumatoid arthritis. A brief description of the study’s purpose is preceded by a comprehensive explanation of the disease condition. Contact information is provided to places where the trials are taking place. Visitors can also email Amgen with questions about the trials directly from the web site.
Abbott Laboratories (www.abbott.com) web site also has an excellent clinical trials section that provides information on research as well as a state-by-state listing of trials for 15 different medical conditions.
A list of hundreds of other biotechnology and pharmaceutical companies is provided in the appendix. These companies can be excellent sources of information on developing drugs.
The Endocrine Society has partnered with CenterWatch to offer the Endocrine Clinical Trials Network, which offers information on drugs in clinical trials as well as the trials themselves. The same information can be found at the Hormone Foundation site (www.hormone.org). You can log on to the American Gastroenterological Association site (www.gastro.org) for links to information on 4,000 trials pulled from NIH and FDA databases. Or you can go to the American Liver Foundation’s site (www.liverfoundation.org) for information and links to most major clinical trial listing services. The National Alliance for the Mentally Ill (www.nami.org) lists clinical trials that have been reviewed by the group’s research department.
The FDA and the National Institute on Aging jointly run the Alzheimer’s Disease Clinical Trials Database (www.alzheimers.org/trials/index.html). It’s accessible from the Alzheimer’s Association web site (www.alz.org), which also separately lists trials that are currently recruiting volunteers. The government sponsors most of these studies. The American Health Assistance Foundation (www.ahaf.org), which funds Alzheimer’s research, has linked itself to all the major clinical trial listing services. It also publishes drug development news on Alzheimer’s disease, glaucoma, macular degeneration, heart disease and stroke.
Many major research centers, such as the Diabetes Research Institute in Hollywood, Fla. (www.drinet.org) and the City of Hope in Duarte, Calif. (a comprehensive cancer center, at www.cityofhope.org), also post information about the trials that they are conducting on their web site.
The Black Health Network (www.blackhealthnetwork.com) and the Association of Black Cardiologists (ABC) (www.abcardio.org) both contain valuable clinical trials information, but ABC’s web site has no clinical trials listings. ABC’s web site has an excellent online brochure called “The African-American Guide to Clinical Trials,” which covers how participants are protected, how clinical trials work, what to expect and how to decide whether or not to participate.
Drug Information
If you are starting your search by first identifying investigational drugs, you will find no shortage of information online. Major newspapers are all available online. The science and technology sections of The New York Times, The Wall Street Journal and the Los Angeles Times are particularly reputable sources of information on drugs.
There are also many web sites to visit. The Pharmaceutical Research and Manufacturers of America has a great web site (www.newmedicines.org) that discusses new drugs under development and the companies that are developing them.
The American Society for Pharmacology and Experimental Therapeutics (www.aspet.org), though designed for clinical investigators, provides links to dozens of pharmacology-related web sites. The most useful links include the American Association of Pharmaceutical Scientists, Bio, BioMedNet, Drug Discovery Online Newsletter and HMS Beagle. The site also offers a link to a directory of pharmacology departments worldwide (including names and emails), where you can try to get your drug questions answered directly.
The American Heart Association (www.americanheart.org) has a wealth of information on research under way on treatments for cardiovascular disease and stroke, as well as the full text of several useful online journals. The American Diabetes Association (www.diabetes.org) offers a free online publication, Diabetes E-News, which contains stories on drugs in clinical trials. The American Society on Aging (www.asaging.org) sometimes runs helpful articles on developing drugs for conditions like osteoporosis. Anyone willing to pay $20 annually to become a member of Children of Aging Parents, www.caps4caregivers.org or (800) 227-7294, will get a newsletter that occasionally announces clinical trials of interest to its readers. BreastLink (www.breastlink.org) features lots of helpful drug development news, as well as a list of upcoming breast cancer conferences. Imaginis (www.imaginis.com) provides access to a number of general and breast cancer-related medical journals and offers a free breast health newsletter with information on newly published medical studies. Check with the health associations for your specific medical condition to see if they publish information on new medical treatments either online or in print form.
Associations and advocacy group web sites are also valuable resources. The Arthritis Foundation (www.arthritis.org) reports on the latest important research advances in rheumatology, including chronic fatigue syndrome, back pain and osteoporosis. It also provides information on lupus researchers that they are funding.
The National Foundation for Infectious Diseases (www.nfid.org) makes online announcements of annual conferences on vaccine research and provides access to vaccine research abstracts. Medscape (www.medscape.com) is a free and authoritative site for news in virtually every therapeutic area. You should go to the medical professional section and scroll down and click on “pharmacotherapy.” Once there, you can find your way to the journal room, where you’ll have access to the content of Clinical Drug Investigation, which publishes information about drugs in all phases of drug discovery and development.
Doctors pay hundreds of dollars every year for access to a database of medical journals. But many of them – including the venerable New England Journal of Medicine (NEJM) and Drug Topics, which covers new drugs in the pipeline and who’s making them – are available at no cost online. The list of free medical journals online continues to grow. These online versions include, in many cases, the full text of articles – not just abstracts. They can be accessed on the web at www.freemedicaljournals.com.
The National Library of Medicine (www.nlm.nih.gov/nlmhome.html) offers some of the largest and best-known databases. These include MEDLINE, which provides citations and abstracts from over 4,600 biomedical journals worldwide, and MEDLINEplus, an easier-to-use version that also offers access to top consumer health libraries and organizations. AIDS and HIV information is best sought through the Library’s Specialized Information Services. BioMedNet (www.bmn.com) offers free access to journal abstracts, as well as next-day news from major scientific conferences and a database of reviewed biomedical web sites used by clinical investigators. Articles appearing in top-notch medical journals can also be viewed from News-Directory.com (www.newsdirectory.com) under both the subjects of “medical” and “pharmacy.” These include some articles appearing in Applied Clinical Trials – otherwise distributed primarily at industry trade shows.
One of the most comprehensive sites is MedBioWorld (www.sciencekomm.at). It is the largest resource for medical and bioscience journals, associations and databases. The available publications include abstracts and even some full-text articles appearing in the Journal of the American Medical Association (JAMA). There are several dozen pharmacology databases alone, including New Medicines in Development, the CenterWatch clinical trial listings and other clinical trial listings. In fact, there are links to many general and specialty trial listing services. You can also do a search for medical conferences.
Offline Resources
CenterWatch’s directory of clinical trials is now available in print form through select public and specialty medical libraries. It is published four times a year. If you are having difficulty conducting your search online, you may want to use this reference. Many newsletters also list trials, especially those focused on cancer and AIDS. Newsletter publishers include government agencies, universities and even some health maintenance organizations.
CenterWatch publishes a series of illness-specific reports called New Medical Therapies. These reports are updated at least once a year and provide an overview of ongoing clinical research activity by disease, including a summary of different treatments under development, results of completed trials and listings of trials currently being conducted. The CenterWatch Monthly and CWWeekly newsletters also list drugs about to enter new clinical trials. Many of these publications can be found at pharmaceutical company and institution libraries. You can also contact local research centers to review their copies of these newsletters. The CenterWatch newsletters and reports are described in detail at the online bookstore at (www.centerwatch.com).
Finding a trial is sometimes just a matter of asking around. Some people learn about trials through friends or relatives who work at a research site or know someone who does. If there are research centers in your area, you can also call the sites to see what kinds of trials are currently under way. Your family physicians may alert you to upcoming trials, although some doctors are reluctant to make referrals to studies where they do not control care and treatment. Self-help and support groups also tend to be very good about alerting members to the latest studies and how to contact sponsor companies and research centers.
Medical libraries tend to be good places to look for information on studies and research results to date. The science reference section of most university libraries is likely to have The Merck Index, an encyclopedia of drugs and biologicals – including the most important ones in phase II and III clinical trials. The print version provides information on chemical, common and generic names; associated companies; literature references; toxicity data; and statements about each drug’s scientific significance. The Merck Index has limited value because it is updated infrequently. As a result, unless you’re looking at a recently published edition, the information may be out of date.
College campuses are often worth scouting out for news about clinical studies happening there or at a nearby research hospital. The hospital can also provide a great deal of useful information. But you can’t necessarily count on the colleges for much up-to-date information on ailments that are uncommon among student-age populations.
A surprising number of patients attend scientific meetings and professional medical conferences where the latest research is being discussed. The fees are sometimes steep – $300 to $500 – but you may walk away with a wealth of information from hallway conversations with physicians and leading scientists. The conferences aren’t all held in large cities. Most major health associations and medical societies list the calendars of conferences and upcoming events in their newsletters and web sites. A list of association web sites is included in the appendix. Contact these associations to learn about their conferences and meetings.
Most non-profit associations, like the Alzheimer’s Association and the American Heart Association, put out annual reports filled with news about promising new drugs in the development pipeline. They’re always happy to put interested patients and their caregivers on the mailing list. Online versions of the reports, while often available, may be abbreviated or tough to read using slow computers.
Some libraries still carry print editions of major newspapers, such as The New York Times, that regularly carry news (and often many ads about) drugs under study. Engel Publishing Partners (West Trenton, N.J.) puts out a magazine called R & D Directions that offers write-ups on drugs that pharmaceutical companies are developing. F-D-C (Chevy Chase, Md.), a division of Elsevier-Sciences, also publishes several valuable magazines and directories of drugs under development. F-D-C’s book, The NDA Pipeline, contains profiles of drugs, their research phase and manufacturer by major disease categories.
These magazines and directories are very expensive. However, you may be able to access them through medical and pharmaceutical company libraries.
It might also be a good idea for you to ask your cardiologist or primary care doctor to take a peek at the front of the PDR Monthly Subscribing Guide (by Thomson Healthcare, publishers of the Physicians’ Desk Reference). A special section entitled “In the Pipeline” is now devoted to new drugs in later-stage clinical trials. This may be another good point for you to begin your search.
How Research Finds You
Studies aren’t hard to find, even for those people not actively looking to participate. Studies are regularly advertised in newspapers and on the radio and TV. They’re posted on bulletin boards in community centers and physician waiting rooms. Call centers now routinely contact homes soliciting volunteers. Trials are also detailed in direct-mail brochures, discussed at patient support group meetings and health fairs, and personally offered as treatment options by thousands of investigators across all 50 states.
Major medical centers and doctors doing research part time generally look to patients in their practice for studies. These centers use direct mail, flyers in their offices and even receptionists who quickly schedule patients who happen to call in with a relevant complaint. Some centers look for potential subjects at free screening programs and health fairs. Other research centers rely heavily on referrals from related clinics or offices, or informal word of mouth. Research centers that are dedicated to conducting clinical trials are more apt to employ mass media approaches to reaching the patient community. If they’re large enough, some centers may have several people on staff who are on the phone night and day trying to solicit patients for studies.
Pharmaceutical companies will sometimes hire a patient recruitment company to develop national advertising campaigns to reach health consumers directly, particularly for large clinical trials.
Breaking the Ice
There is no set way that discussions with a study site begin. After learning about a clinical trial, most people telephone the research center directly. But you may prefer to contact a center by email, or to show up at the center in person. None of these approaches is inappropriate. It’s a matter of preference.
Regardless of your approach, you should plan to deal directly with the study coordinator at the research center. In most centers, coordinators handle most patient recruitment responsibilities, along with the daily research study activities. It pays to get to know the study coordinator early and by name.
Once you’ve identified several clinical trials, and made initial inquiries into whether those trials are appropriate, you and your support network are now ready to carefully learn about and evaluate the best clinical trial opportunities for you.
|
