As a patient, understanding that clinical trials represent an invaluable resource to you as you consider your treatment options can be an empowering realization. Entering a clinical trial may mean that you have the opportunity to receive treatment that might not be available any other way.
But it seems that many cancer patients are not aware of the treatment option that clinical trials represent, or, if they are, that they’re not tapping into the resource: Despite the multitude of new treatment strategies in development, and the efforts of the federal government, advocacy organizations and the biopharmaceutical industry, fewer than five percent of cancer patients participate in clinical trials. Why? Why are patients not pursuing clinical trials, and how can the Internet and online clinical trials resources help patients participate?
But, first things first: What are clinical trials, and how do they help cancer patients?
Clinical trials are research studies designed to evaluate new drugs, devices and treatment strategies. An incredibly important piece of cancer care—and crucial for improving cancer treatment—clinical trials are integral in improving the treatment of medical conditions because they lead to higher standards of care. Clinical trials are especially important for cancer patients because, in the absence of high cure rates, nearly all treatments are developmental in nature, so even the earliest stage clinical trials offer another treatment option worth exploring for patients.
Recently, researchers have found that cancer patients may benefit even more from clinical trials than previously thought. Researchers from The National Cancer Institute (NCI) reported in the New England Journal of Medicine that almost half of all patients treated on phase I dose escalation studies have a clinical response or stabilization of their disease.1 These findings suggest greater benefit than previous studies. Phase I dose escalation trials are the earliest phase of clinical trials. These trials are predominantly designed to determine the safety and/or side effects of new cancer drugs and drug combinations.
Phase I drug trials are often the only way patients can be treated with a new drug or combination of drugs, and the anticancer activity determined in phase I trials is often used to determine whether or not phase II trials—designed to evaluate the activity of a drug in a specific cancer—will be performed. If no anticancer activity is found in a phase I trial, further study of the drug is generally not pursued.
So why, if cancer patients benefit from trials, do the majority of patients opt not to participate in clinical trials? Doctors are increasingly interested in understanding the answer to this question. Researchers at the University of California–Davis (UCD) Cancer Center recently evaluated the barriers that stop patients from enrolling in clinical trials.2 The results indicated that lack of communication between doctors and cancer patients presents a barrier to clinical trials participation. The study results also indicated that 70 percent of patients in the study were excluded from clinical trials either because of a perceived lack of interest, a scarcity of available protocols and/or failure to meet eligibility criteria for UCD trials.
These studies reflect the poor communication between patients and doctors, which can be understood as a reflection of the fact that patients are often excluded from consideration for clinical trials because of a perceived lack of interest on the part of their doctor or because there is not an appropriate trial available with their doctor. Perhaps more importantly, however, the study also tells us that the majority of cancer patients are unaware of the potential role that an appropriate clinical trial may play in their treatment.
The UCD study reveals the fact that poor communication between doctors and patients, and lack of accurate information, is stopping patients from pursuing clinical trials that might provide valuable treatment options. Doctors are not aware that their patients are interested in participating in trials in some cases, and, in others, although there might not be an appropriate trial at the particular cancer center or clinic where the patient is currently receiving care, there is probably an ongoing trial at another facility that would suit the patient’s needs.
In addition to issues related to poor communication and lack of accurate information, the UCD study also reported that patients don’t participate in clinical trials most commonly as a result of a desire for other treatment, because of distance from the cancer center and because of insurance denial. Often, more accurate information can also help patients overcome these barriers.
The Internet provides an ideal solution in many ways to bridge the gap between clinical trials and the patients who can most benefit from them. And, cancer and the Internet are uniquely suited when it comes to patient participation in and awareness of clinical trials. First and foremost, cancer is a life-threatening condition for which there is often suboptimal treatment. Second, cancer, unlike many other medical conditions, does not typically require immediate treatment in order to obtain the best outcome. For example, while heart attack victims need immediate emergency care, cancer patients may require several weeks to complete an evaluation. In most cases, a cancer patient has both ample time and incentive to research treatment options thoroughly. The Internet provides a vehicle for real-time distribution of information directly to cancer patients and their families.
The reality is that patients are anxious for more information about their diagnosis and their treatment options, and they are already turning to the Internet as a resource. In recent surveys, patients report that the primary reason they use the Internet is to seek cancer treatment information.3 Searching for clinical trials information was rated the most important Internet service, and 60 percent of patients were actively seeking access to clinical trials. Patients searched an average of nine websites on the Internet and reported that cancer specialty websites such as www.CancerConsultants.com and www.Oncolink.com were the most useful and trusted sources of information.
The Internet accomplishes two key objectives for cancer patients and their families where clinical trials are concerned. In a broad sense, the Internet provides a wealth of information for patients and their family members about the significant role of clinical trials in oncology. More important, however, are the solutions that that the Internet offers to facilitate access to clinical trials by bringing patients and clinical trial research sites together.
Currently, there are several online resources that facilitate access to clinical trials. It is important to realize that no single website lists or facilitates access to all available clinical trials, and patients typically need to search several sites. Moreover, all sites that list clinical trials do not have one unified mission. They each provide different services and operate under different business models.
The National Cancer Institute (NCI) website, or PDQ, lists clinical trials being performed at federally funded research institutions, as well as those electively submitted by the biopharmaceutical industry and providers of cancer services. The NCI website currently has the greatest breadth of clinical trial listings, but it is by no means comprehensive in scope.
CancerConsultants.com is an oncology-dedicated Internet site designed to facilitate access to clinical trials exclusively for cancer patients. CancerConsultants.com lists oncology clinical trials and provides these trials in the context of over 5,000 pages of educational resources and daily news on the treatment of cancer. By serving as an educational resource, CancerConsultants.com not only lists oncology clinical trials, but also provides a greater understanding of where clinical trials may fit into the overall management plan of an individual patient. CancerConsultants.com also offers specific services designed to help individual patients identify appropriate clinical trials for their situation. The site also uses cancer information specialists to perform custom clinical trial searches.
CenterWatch.com is an example of a website designed to provide a comprehensive clinical trials listing service for all medical conditions. The site seeks to provide comprehensive clinical trials listing services, but it doesn’t specialize in oncology.
Although it is too early to determine the effect that the Internet will have on patient participation in clinical trials, it seems likely that the Internet will make a significant contribution in making patients aware of clinical trials and facilitating access to clinical trials. We already know that patients are using the Internet to research their diagnosis, and market research indicates that increasing numbers of cancer patients are using the Internet specifically to seek clinical trials information. Moreover, the broad strategy of educating patients about the role of clinical trials, in combination with the specific recruitment services that are gradually evolving, should improve patient participation in clinical trials in the near future.
Internet-Based Clinical Trial Resources:
National Cancer Institute
Nat’l Center for Complementary and Alternative Medicine
Office of Cancer Complementary and Alternative Medicine