Most people first become aware of clinical trials when they are out of standard treatment options for a health problem and they learn about an experimental drug either through their own research, a recommendation from their doctor or a specialist, or a suggestion from a loved one.
Recruiting people to participate in clinical trials has traditionally been a somewhat hit-or-miss process that relies heavily on the relationships that biopharmaceutical companies have with clinical research organizations, academic research centers, and the investigators that run clinical trials.
Even in the United States, which has among the most robust clinical trial participation rates in the world, the participation rate is less than 1 percent of all Americans, says David Leventhal, Director of Clinical Innovation for Pfizer’s Global Product Development.
Clinical trials are how potential new treatments are tested for safety and efficacy, and they require the participation of volunteers —from healthy individuals looking to contribute to scientific knowledge to patients seeking hope for an intractable condition.
Recent innovations are making it easier for patients to find clinical trials and, conversely, for researchers to find participants. Read on to see what better patient recruitment for clinical trials means, not only for researchers, but also for patients.
Electronic Medical Records
There’s been a lot of conversation about how electronic medical records (EMRs) — that is, your medical history stored in a database — might be able to improve health care. Subject to appropriate consents having been obtained from the individuals whose data is in the EMRs, one area where EMRs are beginning to make a significant contribution is helping clinical researchers identify potential patients for clinical trials.
“Do we know which patients are living with which diseases and where?” This, according to Leventhal, is one of the first questions that need to be answered to recruit clinical trial volunteers. “With paper-based systems, it was very, very difficult to really understand that. It required highly disciplined research to understand the demography and epidemiology of what was going on with a particular disease.”
Consistent use of EMRs, which began in earnest only about a decade ago, can giveclinical researchers more insight into the best recruitment strategies for a clinical trial. In the traditional model of clinical trial recruitment, sponsors rely on advertisements or for investigators to reach out to patients, asking them if they want to participate. But with electronic medical records, “you have the ability to ask deeper and deeper questions of an investigator or even of a large health system, to be able to find eligible patients and then the appropriate health care professionals may reach out to them,” Leventhal says.
Of course, there is still more work to do before EMRs reach their full potential as a valuable tool for clinical trial recruitment. Many trials require recruitment across multiple geographic areas, buthospitals and clinics in different countries, or even different states, may collect data differently. For example, in some medical records allergic reactions to a substance are categorized as side effects; in others the reactions may be listed as allergies. A trial that uses medical records to recruit patients with a particular allergy could miss an important group of potential participants due to this type of inconsistency in categorizing data.
Designing a Better Clinical Trial for Better Recruitment
However, even with the current limitations, information taken from EMRs can still help scientists design more effective clinical trials. Even when a clinical trial’s methodology is scientifically sound, there may be challenges if you don’t take real-world effects into consideration, and that’s another area where electronic records have value.
Looking at aggregated, de-identified data from EMRs during the protocol design stage helps researchers create studies based on real world data. Informed by EMRs, clinicians can determine whether they are formulating eligibility criteria that have a realistic chance of actually recruiting patients.
Of course, not all protocol design issues can be addressed by using EMRs. Sometimes researchers also need to consider the capabilities of the trial subjects. Leventhal cites the example of a pediatric study that required children to fast while undergoing tests during what turned out to be a very long dayand the reaction of parents when approached by researchers to allow their children to participate.
“We’re trying to consider the input from both patients and patient advocacy organizations for the design and execution of our clinical programs to make sure that we have the highest probability of recruiting not just eligible patients but patients who will continue to participate in the study for the duration of the study,” says Leventhal.
New Ways to Get the Word Out
The main way most Americans can get information about clinical trials is from ClinicalTrials.gov, which is a site operated by the National Library of Medicine at the National Institutes of Health, and on which sponsors list clinical trials that are being conducted around the world. But as the website is designed for multiple uses (registration and results) and users (including health care professionals), we have looked for additional ways to help patients find trials that may be right for them.
One way Pfizer is trying to make finding Pfizer-sponsored trials easier is through its “Find a Trial” search capability on Pfizer.com, which presents all of Pfizer's currently active and recruiting clinical trials in a patient-friendly format.
There are also efforts to give back to the patients through Pfizer’s clinical trial participant alumni community called PfizerLink, Leventhal says. Through PfizerLink, trial participants who opt-in may receive a summary report in easy-to-read, non-technical language that explains why the study was done, how it was done, and the aggregate results. PfizerLink also offers trial participants the option to download their own individual data collected in the trial that might be useful to share with their healthcare team members as they receive ongoing care.
A Mission With a Very Personal History
The issue of making experimental drugs more accessible to patients is very close to Leventhal’s heart; his father is still alive today, Leventhal believes, thanks to his having enrolled in a clinical trial after being diagnosed in 2005 with metastatic melanoma.
“It saved his life,” Leventhal recalls. “It was very much that kind of situation where at the time the treatment options for melanoma were really very limited.”
“It’s a perfect example of a patient being out of options, and not being able to know what their next step is,” Leventhal says of his father, adding that the first clinical trial that his father’s oncologist recommended was a traditional chemotherapy study, which both Leventhal and his two siblings, both medical doctors, believed wouldn’t be a good fit.
But following a different clinical trial that Leventhal was able to find, his father has been cancer free since 2007 and recently celebrated his 80th birthday — a happy example of what participating in a clinical trial can sometimes mean.