The Pitfalls of Clinicaltrials.gov
As a cancer patient or a caregiver for a loved one exploring different cancer treatment options, you may be looking for innovative treatments, typically offered via clinical trials, or interested in supporting the advancement of a cancer cure via trial participation. This brings you to the question: Why is it so hard to find the clinical trial right for me? While there are several obstacles between an interested patient and clinical trial recruitment, this question must be answered first by understanding the strengths and the weaknesses of the number one goto tool created by the federal government addressing those needs - ClinicalTrials.gov.
What is ClinicalTrials.gov?
This registry of over 300,000 clinical trials is run by the United States Library of Medicine (NLM) at the National Institutes of Health (NIH). It was created due to the Food and Drug Administration Modernization Act of 1997 (FDAMA), which required the US Department of Health and Human Services (HHS) to develop a public information resource for federally and privately funded global trials. In February 2000, the site was made available to the public. Today, ClinicalTrials.gov has over 10,000 trials in the United States dedicated to cancer research. “The information in the registry was intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers.” While the original intention was to inform patients on the development, safety, and efficacy of innovative drugs, in reality, it did not turn into a practical, accessible, and free guide for cancer patients that are in dire need of finding innovative therapies.
Why are clinical trials important?
After years of research, tests, and preclinical trials, researchers conduct clinical trials, a major step in establishing robust new treatment options and identifying ways to diagnose and reduce the disease’s risk. Clinical trials, composed of patient volunteers, test the efficacy and side effects of these new treatments. Thus, clinical trials are important for medical research companies, future patients, and present patients. Medical research companies can continue their research and develop treatments based on the findings of the trials. Future patients receive improved methods to treat or eliminate their cancer. Present patients receive innovative treatment that can assist them beyond the capabilities of the standard of care.
What are the pitfalls of ClinicalTrials.gov?
Let’s walk through the experience of Maggie, a 62-year-old woman diagnosed with vaginal cancer just a year ago. After enduring the standard of care treatment, including surgery, chemotherapy, and radiation, the cancer continued to progress. Her medical team suggested that she undergo intensive chemotherapy with a 30% survival rate. Left exhausted and disheartened, Maggie and her husband were desperate for newer innovative remedies outside the standard medical procedure. They spent two days scouring ClinicalTrials.gov, but without an oncologist by their side, their search remained fruitless.
1. Overwhelmed By Medical Jargon
Maggie and her husband quickly realized that ClinicalTrials.gov is challenging to navigate through and understand. By simply searching the website for vaginal cancer trials in the United States, over 40 studies were flagged on her browser. Not to mention, the website is filled with medical jargon, a major obstacle for understanding each trial intervention as an average patient. Some of the trials simply didn’t test a new treatment but rather a diagnostic or complementary therapy. Clinical trials are also conducted by targeting specific populations, thus requiring patients who meet specific inclusion and exclusion criteria. With a serious diagnosis, Maggie spent precious hours sorting through each trial’s eligibility criteria and looking up countless medical terms to determine her candidacy for a novel treatment.
2. Difficult to Prioritize for Yourself
After arbitrarily determining her candidacy, Maggie needed to research the individual drugs and devices being studied to assess their safety profiles and efficacy data. ClinicalTrials.gov, as a directory, in no way differentiates the more promising or safer trials from those with unconvincing results and higher rates of adverse reactions. Without a team of experienced professionals on Maggie's side, she had great difficulty understanding which trial is best for her condition. This trial recruitment system lacks a structured capacity to discern whether a patient should enroll in a trial, as well as the ability to cater the search process to the individual user.
3. Outdated Information
Despite being a government website, ClincialTrials.gov lacks a powerful central regulatory authority, resulting in outdated information. The principal investigator, the person(s) who carry out the study, is responsible for updating the trial online. Upon contacting trial sites to inquire about Maggie’s eligibility for treatment, a common response was that the trial is “no longer recruiting patients.” Unfortunately, failure to update a trial status is a frequent occurrence, which leads to unnecessary confusion for desperate patients and providers. Alarming responses from trial coordinators, including “I don’t believe this study ever recruited for vaginal” cancer, point to the futility of the system’s search engine. Through Maggie’s search, another company responded, “our trials are currently paused while the company evaluates options for the remainder of the year.” Failure to update trial information in the registry is unethical yet commonplace.
4. Poor Communication
ClinicalTrials.gov is not a direct communication platform, meaning patients cannot utilize the interface to communicate with study coordinators directly. All studies do include contact information, theoretically through which enrollment proceedings can begin. More often than not, however, the contacts listed do not lead to the research coordinator; hence, they cannot provide the necessary information for which users are looking. Unfortunately, a typical inquiry involves multiple phone or email transfers and days waiting for officials to respond. The website shifts the responsibility of initiating contact with its users, which adds an unnecessary burden to an already struggling population.
Despite acting as a public resource, the poor design and upkeep of ClinicalTrials.gov deem it far from patient-friendly. It would be challenging for a patient, or family member, to pinpoint which clinical trial is best for their cancer prognosis. Nevertheless, ClinicalTrials.gov is only one hurdle in a trial enrollment. To find and understand a suitable cancer clinical trial, patients rely heavily on their oncologist, who often don’t take the time to consider this option under the jurisdiction of the medical system. Patients and their medical team need an unbiased supplementary team to bridge this gap.
While the creation of ClinicalTrials.gov was a step in the right direction, it does not fully address the needs of cancer patients looking for clinical trials. A more sophisticated methodology is needed in order to guide cancer patients through the complexity of a cancer journey that often requires transitioning between standard and innovative care.