Despite advancements in clinical research technology over the last decade, recent research from the Tufts Center for the Study of Drug Development (CSDD) suggests that we are not conducting site activation any faster today than we did 20 years ago.
Effective patient recruitment for clinical trials is critical to success in meeting timelines and budget goals. Recruitment shortfalls for study participants creates a major problem for the pharmaceutical industry by delaying new therapies from reaching the market, estimated to represent a daily loss of $1 – 8 million dollars by Cutting Edge Information. In addition, failure to enroll the required number of patients in a timely manner at investigator sites can compromise a trial's statistical power and scientific validity.
Unfortunately, patient recruitment in clinical trials is a growing challenge and concern for the pharmaceutical industry. Today, nearly 80% of clinical trials fail to meet enrollment timelines and up to 50% of research sites enroll one or no patients. According to the Tufts Center for the Study of Drug Development (CSDD), clinical trial enrollment rates overall have dropped 20 percent since 2000, with only 2 million volunteers now participating.
Reasons for Recruitment Challenges
Between 2000 and 2007, the total number of clinical trials increased by 15%, heightening competition for study participants, while at the same time the number of new investigators declined by 10%.
Another factor contributing to decreased patient enrollment and retention rates is increase study complexity and eligibility criteria. A 2010 study by Tufts CSDD found that the median number of procedures per clinical trial increased by 49% between 2000-03 and 2004-07, while the total effort required to complete those procedures grew by 54%. According Ken Getz, director of sponsored research programs at Tufts University Medical School and chairman of CISCRP (Center for Information and Study on Clinical Research Participation), "More complex and burdensome protocols are extending study cycle times, increasing costs, and challenging patient recruitment and retention." Getz also noted that the rise in the number of eligibility criteria used to screen volunteers has contributed to a decline in volunteers enrolling in clinical trials. “And once volunteers enroll,” he said, “the larger number of procedures per protocol is dissuading study volunteers from staying in trials through to completion.”
In addition, given the volume of clinical trials conducted worldwide and the increasing number of inclusion/exclusion criteria, the task of matching patients to appropriate clinical trials has become quite challenging. At any given time, there are typically over 200,000 ongoing clinical trials worldwide, each with its own specific inclusion and exclusion criteria. Meanwhile, physicians have only 15 minutes, in many cases, to explore these options with a patient. Usually, doctors don't even mention the option of participating in a trial to patients, in part because they aren't aware of them or lack the time, resources or staff to enroll their patients.
Clinical trial information has been available online through ClinicalTrials.gov, part of the National Institutes of Health, since 2000, but the site can be hard to navigate and it isn't always up to date. The government site currently lists over 225,000 trials in 192 countries. Combing through this site looking for the right clinical trial can simply be overwhelming for patients and time prohibitive for doctors.
Clearly, for patients who are considering clinical trials as an option, the complexity of finding the right trial and then fully understanding the requirements, risks and benefits is often a big challenge. Fortunately, a growing number of web-based and mobile tools are helping patients connect with appropriate clinical trials.
Clinical Trial Patient Matching Options
Standard approaches to patient recruitment for clinical trials - newspaper ads, radio, television, posters, fliers, etc. – are simply not producing adequate results in today’s digital world. New approaches are necessary if patient recruitment challenges are to be rectified. Fortunately, a number of platforms have emerged in recent years that are helping patients find the right clinical trials for them. There are many different types of clinical trial matching services, but they all work to connect the right patients with the right studies, aiding sites and promoting clinical research awareness.
For sake of clarity, we can arrange clinical trial matching services into three different categories - services that require registration and auto-match patients to clinical trials, services that do not require registration and simply allow patients to browse online databases of clinical trials, and disease-specific services.
Registration-based services: Similar to a dating site, patients seeking a clinical trial enter key demographic and health information into an interface. Based on this information, the service matches each patient with the most suitable studies currently enrolling, providing basic study information, as well as, typically allowing communication with other patients.
One example of this kind of service is PatientsLikeMe, which allows users to create an account and enter basic demographic information to get ongoing notifications about clinical trials they may qualify for. Once registered, patients can also connect with other patients who are working to manage the same condition, share health experiences and track treatment history. In the process, users generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 325,000 members, PatientsLikeMe has become a trusted source for real-world disease information, as well as, a clinically robust resource that has published more than 60 peer-reviewed research studies.
Services that do not require registration: These services typically offer an easily searchable online database, allowing patients to search clinical trials that are recruiting patients and contact those that they are potentially interested in. Some of these kinds of “no registration required” services will allow you to contact them by phone, where a representative will speak with you about your condition and let you know about clinical trials that you may qualify for.
A good example of this kind of service is CenterWatch. First launched in 1994, this service provides the largest online database of industry-sponsored global clinical trials actively seeking patient volunteers. CenterWatch provides patients with unbiased information on thousands of currently enrolling clinical trials. Patients can search the CenterWatch database by medical condition, geographic location or research center to find the trial that best meets their needs. Contact information is shown along with each trial listed, allowing patients to contact trial researchers directly once they have identified a trial they are interested in. Patients can also sign up for a free e-mail newsletter that will send them a message whenever new trials are added in their area of interest.
Disease-specific services: Some clinical trial matching services specialize in certain diseases and conditions. Most of these are hosted by patient-advocacy groups that play matchmaker - linking patients to researchers who need them for clinical trials. These services usually allow patients to connect with and be a part of a larger community of people who are all focused and motivated to find effective treatments for the same condition. HIV/AIDS groups in the 1980’s started the trend of patient communities focusing on trial recruitment and retention, and dozens of disease-specific groups have followed suit - breast cancer, autism, diabetes, asthma, etc.
A good example of this kind of service is The Michael J. Fox Foundation for Parkinson's Research. The Fox Trial Finder has helped to recruit more than 60,000 volunteers for Parkinson's disease trials. Potential volunteers register on the website and create a profile with their location, gender, date of birth and brief medical history. The system then generates a listing of possible trial matches from the database of recruiting Parkinson's disease trials, and offers a secure messaging service to contact investigators. Researchers can also review anonymous profiles of eligible volunteers and contact them through the messaging system to further explore participation.
In order to address the critical issues of patient recruitment and retention in clinical trials, the number and diversity of clinical trial matching services has expanded rapidly in recent years. This dizzying array of new services has created its own set of problems.
It used to be that the education and motivation required for patients to find the right clinical trial to participate in left many potential volunteers feeling overwhelmed. Organizations like the National Institutes of Health (NIH) tried to help by providing a set of questions that patients should ask before enrolling in a clinical trial:
- What is the purpose of the study?
- Who is sponsoring the study, and who has reviewed and approved it?
- What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful?
- What are the possible risks, side effects, and benefits of taking part in the study?
- How might this trial affect my daily life? Will I have to be in the hospital?
- How long will the trial last?
- Who will pay for the tests and treatments I receive?
- Will I be reimbursed for other expenses (for example, travel and child care)?
- Who will be in charge of my care?
- What will happen after the trial?
Now, we have organizations like the American Cancer Society publishing lists of questions for patients to ask themselves when vetting clinical trial matching services:
- Is there a fee for using the service?
- Does the service keep my information confidential?
- Where does the service get its list of clinical trials?
- Does the service rank the studies in any particular order, and is the rank based on fees they receive?
The rise of various clinical trial matching services is certainly a step in the right direction towards make clinical trial participation an easy process for potential volunteers, but there is still work to do to streamline the process for patients. The bottom line is that busy lifestyles and the frenetic pace of life effectively assures that clinical trial recruitment will only succeed when the process is made easy and hassle-free for the patient.
While these match making solutions hold much promise for rectifying the problem of declining patient enrollment in clinical trials worldwide, now patients have to decide which clinical trial matching service to use. Is a matching service the right mechanism for finding the right clinical trial? Or is it the best option in only some cases? Most of these services target patients directly, but why don’t they target doctors instead?
The reality is that further centralization of the patient matching process needs to happen in order to facilitate an easy, smooth and efficient experience for potential trial volunteers. In other words, the process needs to be more patient-centric.
Sujay Jadhav, CEO of goBalto, has more than 20 years of experience at leading Silicon Valley software providers, with a life-sciences focus. Jadhav was most recently senior vice president of global corporate strategy and development at Model N, where he filled multiple roles, from corporate development to overseeing their life-sciences analytics and SaaS business unit. His career has also included strategic consulting at Booz Allen Hamilton, product strategy at CommerceOne and general management roles at Singapore Telecom. He received his undergraduate degree from the University of South Australia and an MBA from Harvard University.