As people flock to the Internet for health information, the Web grows as a patient recruitment pathway.
Patient recruitment is a team sport, no individual controls it completely. For a patient recruitment campaign to be successful, the sponsor, CRO, investigator sites, and the supply groups all have to work together. Each party plays a distinct role in educating people about clinical trials and their importance, in informing patients about what trials are available, and in enrolling the right patients into the trial. With new communication channels like the Internet, this process is evolving.
Recent research from Harris Interactive indicates that of the 184 million U.S. adults now online, 150 million have searched the Web to obtain health care information. A further survey conducted by Harris found that online usage in the United States has risen from seven or eight hours a week in 2002, to 14 hours in 2008, with users now including the large majority of demographic groups.1
Health is one of the top subjects for people seeking information using the Internet, which naturally makes it a sensible outlet to disseminate general and specific information about clinical trials. This trend means the Internet has increasing impact on the attitudes of the general public, which can help to create a positive climate for recruitment, as well as provide the opportunity to reach people with conditions that might make them appropriate for a clinical trial.
According to Maura Musciacco, author of the 2008 Datamonitor report, Online Patient Recruitment Strategies—Optimizing the Clinical Trial Process, Web surfers tend to be more interested in clinical trials than those who view posters in a clinic.2 And while she acknowledges that only 20% of clinical trials employ the Internet for recruitment, she suggests those companies that do, reap the benefit both in the number and quality of patients. She further contends that online recruitment will escalate as patients become increasingly more proactive and the rise in Internet penetration helps spread information.
For patients seeking to join a clinical trial, there is no centralized online source, but a variety of Web sites they can turn to for information about a therapeutic area where trials are being conducted. These sites contain information on studies that are underway, are seeking patient enrollment, and are forthcoming. The number of clinical trials listed on public online registries has increased dramatically in the past few years, and people searching for information on what's going on can typically browse for clinical trials by region, therapeutic area, sponsor name or research site.
ClinicalTrials.gov/, a service of the U.S. National Institutes of Health (NIH), is the largest online repository for clinical trials information. This registry of federally and privately supported clinical trials conducted in the United States and around the world had more than 87,500 clinical trials listed as of March 2010. It provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. The site also contains a glossary of words and terms related to clinical trials. As a public resource, sponsored by the NIH, ClinicalTrials.gov/ does not accept advertising.
Disclosure Web sites, such as ClinicalTrials.gov, require some level of medical expertise to understand the terminology. There are alternative sites that are also designed to be educational and informative that provide a listing of trials couched in layman's terms, as well as information on how clinical trials are conducted, what types of questions volunteers should be asking, and how to go about finding information directly from a doctor or investigator. A good example of this type of Web site is ciscrp.org/, run by the independent, nonprofit organization the Center for Information & Study on Clinical Research Participation (CISCRP). Another Web site, ClinicalResearch.com/, provides users with information about participating in trials and where to find them. This site also gives users the ability to sign up for contact about future trials.
In the future, online communities of people interested in health care topics will have a significant impact on patient recruitment. iGuard.org/, a Quintiles venture started up in 2007, is an example of how this works and is actively helping U.S. patients manage their health through a free online service. Patients enroll at iGuard.org/ and—after answering a series of simple questions about their demographics, medical history, and conditions —become part of a membership network. Members are sent personalized risk ratings about the medications they take, including interactions between drugs, as well as drug safety alerts when an issue with a drug arises. They can also access health-related information, and if they wish, can express an interest to be contacted about future clinical trials.
The most common way to advertise clinical studies on these sites, and the Web in general, is through banners and search engine optimization. These techniques guide people to a Web site that explains the trial and allows interested volunteers to do an online screening. The screening will include questions on gender, age, what drugs the person is currently taking, and crucially, their zip code, in order to ensure they live within reasonable distance of an investigator site—usually within a radius of 30 miles.
Screening tools like these are often used even with conventional media, TV, and radio. Advertisements will usually give a toll-free telephone number or a Web address. The Everyday Medical Heroes campaign initiated by CISCRP, for example, directs people to the toll-free number or the CISCRP Web site. This series of print advertisements that picks out ordinary individuals as heroes has raised interest and curiosity among a wide cross-section of the population, and has helped to engage the public in thinking differently about clinical research. Without patient volunteers, medical advancement would be impossible and their contribution to society cannot be overstated.
This combination of print and online advertising or information and screening has paid off with the Heroes campaign, with results indicating that patient recruitment has doubled in markets where the ad has been running.
The Internet as a health surfing tool is perhaps the most popular resource for people who have niche or chronic conditions and who may have exhausted other treatment options. An understanding of the patient pathway for each disease or condition (i.e., how the patient presents with the disease and how they move through the health care system in a particular country or market) is therefore important in determining what type of media is likely to be most effective in getting particular patients to make an informed decision about trial participation, and at what stage in the patient pathway to target the advertising.
A practical example of these techniques working together is a recent Quintiles study into major depressive disorder. Many current therapies for severe depression aren't fully effective and this dissatisfaction is a key driver taking people to the Internet in search of possible relief from their problems. Moreover, there is often a stigma attached to depression, so sufferers often prefer to receive information in a solitary way rather than talking to people on the phone.
Quintiles' approach was to run an online media and search engine strategy so that anyone Googling the word "depression" would reach a clinical trials site. If they clicked on this site, they would then arrive at a Web site for the clinical trial that included a self-reporting questionnaire. At the same time, members of the iGuard community were asked if they would be interested in information about clinical trials and if they said yes, they were sent the information about the trial, with a click through to fill out the questionnaire.
With increasing traffic to health-based sites, the Internet has also become a useful market research tool. Banner ads on existing online community sites that click through to a questionnaire can be an effective means of testing out a study protocol. If the questionnaire includes general questions about a particular disease area, as well as a series of questions that directly relate to the particular trial, such as inclusion/exclusion criteria and the number of patient visits, it does not need approval from an Investigational Review Board. By directly targeting questions at an online community in your study area, the resulting answers can provide significant insight into the feasibility of a given protocol.
Online communities have become an invaluable means of message testing. Messages designed to help target patient groups understand what a particular trial is about, or those designed to attract the attention of potential volunteers, can be tested on relevant online sites. Even creative design work can be published on the site for comment.
Within this framework the Internet is becoming an important enabler not just in helping to attract patient participation in clinical studies and in message testing, but in facilitating the selection and readiness of the investigator sites.
There are three key processes in which the Internet can play a role in helping to get sites selected and up and running quickly: site feasibility, administration and investigator education, and training.
The noted decline in the numbers of experienced clinical investigators in North America and Western Europe, combined with the increasing size and scale of clinical trials, has made the right selection and evaluation of investigators and sites ever more critical for successful completion of the trial within budget and timelines as well as the generation of high quality data. Assuming the CRO or sponsor has an established relationship with an investigator site, the Internet can be an efficient way to send a series of questions to a site in order to assess their suitability for a given protocol, such as whether they have the appropriate patients, the right equipment, and the right staffing.
It can also help reduce the administrative burden at the site by allowing fast document transfer in place of overnight delivery or the now rather outmoded fax. An important step forward here has been the ability to verify signatures online. These electronic transmissions are also helping sites move a step closer to eClinical, paperless systems.
Of course, before a CRO or sponsor can even think about recruiting patients into a trial they need to ensure the site investigators and nurses are trained, able to care for the patients, and can enroll patients in the appropriate studies. Indeed, the relationship between the physician and/or nurse and patient is the most important step of the recruitment process; decisions on appropriateness of a given trial and ultimately participation in the trial are made at this point of care. Arguably, it is in this third area of education and training where the Internet is proving highly beneficial.
By making training more flexible and convenient for study staff, and by saving them traveling time to meetings, it has helped lighten the load for both the investigators and nurses at the initial phase of the study. Moreover, with increasing numbers of complex and long-term studies, such as oncology, staff turnover during the course of a trial has become more of an issue. E-education allows this training material to be archived so that new staff coming onto the trial can have immediate access to the original material.
For the moment, the Internet is not a panacea, nor has it replaced the more traditional forms of patient recruitment such as TV, radio, and magazine advertising. Rather, it is part of an integrated approach; one tool in an armory of different tools, albeit a useful one, with growing potential.
In the future, it has the potential to become a much more powerful resource, and to be used in increasingly innovative ways, particularly in the area of online communities. For the moment, however, it is a team player. To quote Musciacco, "it is the synergy of all methods—doctor, media and Internet—which will ultimately increase patient enrolment."
Christopher H. Cabell,* MD, MHS, FACC, is Senior Vice President, email: [email protected], and Jim Kremidas is Vice President, Patient Recruitment, both for Quintiles Global Access to Patients, 4820 Emperor Blvd., Durham, NC 27703.
*To whom all correspondence should be addressed.
1. Four Out of Five Adults Now Use the Internet, harrisinteractive.com/, November 2008.
2. M. Musciacco, eHealthInsight Series: Online Patient Recruitment Strategies: Optimizing the Clinical Trial Process, Datamonitor, May 2008.
3. T. McAlindon, M. Formica, K. Kabbara, M. LaValley, M. Lehmer, "Conducting Clinical Trials Over the Internet: Feasibility Study," British Medical Journal, 327, 484-487 (2003).