Clinical trials are still the only viable way to bring new medicines and products to market. However, successful clinical trials require participants (subjects), locating, and screening-eligible participants. This can be challenging.
Simply locating a sizable pool of potential participants in the first place is challenging and often after the initial contact, potential subjects are found to be ineligible or simply choose not to participate.
Clinical trial eligibility screening and recruitment is especially challenging in areas like oncology, where new treatments increasingly focus on very narrow genetic profiles or disease types and competition for trial subjects are extremely high.
There are many trials, and they're all on tight timelines and all vying for the participation of the same patients.
Patient Recruitment Remains The #1 Issue For Clinical Trial Coordination
Even though recruitment often accounts for up to a third of trial budgets, studies everywhere are struggling to enroll enough patients on time:
- As many as 10% of all clinical trials fail to recruit even a single patient.
- 37% of all sites never meet enrollment targets.
- Almost a fifth of cancer clinical trials fail due to insufficient patient enrollment.
Even for the trials which do meet enrollment goals, doing so on time can be difficult. In the U.S., nearly all (90%) of trials fail to hit recruitment targets on time.
According to a study done at Tufts Center for the Study of Drug Development, Phase 2-4 study timelines often double just to meet desired enrollment levels.
Those delays translate directly into lost revenue: for everyday a trial is delayed, sponsors spend $37,000 to keep the trial operating and lose up to $8 million in revenue.
Study participation is also key to ensuring that patients can receive the care they need, as the only way many patients can receive or access the most cutting-edge therapies.
Improving clinical trial enrollment and screening is clearly important for ethical, medical, and financial reasons. To actually do so, pharma companies need to effectively:
- Maximize the number of patients enrolled.
- Minimize the expense of recruitment and screening.
- Minimize the time from initial contact - randomization.
- Minimize the number of people who drop out before the trial ends.
The best way to do all of this is to focus resources only on patients who are likely to be qualified and want to participate. Then, the focus is to keep those people engaged throughout the trial.
However, this takes time and money that can both be in short supply.
So, how can pharma and biotech companies work to improve and simplify the clinical trial eligibility screening and recruitment process to ensure trial success?
The answer is through emerging pharma technology.
Technology can streamline patient selection, screening, and reduce attrition. However, many pharma companies aren't yet taking advantage of the tools that is already available.
This makes the current moment a key opportunity to get ahead of the curve, reach more patients, and meet enrollment and screening goals cost-effectively.
Here Are Just A Few Steps to Improve Clinical Trial Recruitment & Screening:
1. Understand What Drives Participation (Or No Participation)
Knowing how patients encounter trial-related information is key to reaching bigger and more qualified audiences.
In a major CISRP global study from 2015, over half (57%) of everyone surveyed said they'd be willing to participate in clinical research. A bigger majority (79%) think it's safe, and up to 96% of respondents had a positive or neutral opinion of trials.
On the other hand, a 2016 survey found that 65 percent of respondents say they're unlikely to ever enroll in a clinical trial.
So, why is it so hard to get people to participate?
Recent surveys of patients in the U.S. revealed that there were a number of factors, including:
- Not knowing about trials or not receiving information about them from a trusted source.
- Being afraid of the risks or of only getting the placebo.
- The inconvenience of traveling to the treatment center for the trial or performing study activities.
Life science companies can't always directly influence all of these factors, but awareness of the current landscape is a critical first step towards improving systems targeting the patients making these decisions.
Leveraging built-in analytics and machine learning modules can help simplify this process and provide easy to understand visualizations of patient needs and interaction over the course of past trials to inform future recruitment ventures.
2. Use Digital Channels To Reach More Patients Directly
Digital channels, including social media, are key to meeting enrollment targets.
More than half of Americans have no awareness of clinical trials they might be eligible for and don't know where to go to find that information.
This shouldn't come as a huge surprise, as surveys of CROs revealed that most participants came from a limited pool of existing patients. Almost half of study participants were found in in-house databases.
Very few people are finding trials directly or through digital channels.
While these off-line strategies still work, they aren't succeeding in meeting modern needs.
Nearly all marketers in other fields already use social media and digital marketing to reach new customers; these methods are popular because they work.
80% of people look for health info online; digital advertising is a potent and currently under-tapped resource for patient recruitment.
Of course, digital channels like social media do face regulatory barriers.
However, in many cases, using a certified provider, shutting down public comments, or performing other simple steps are enough to secure IRB approval to reach out to potential participants through social media, online ads, and other digital communications.
Digital channels also offer a number of other benefits, including:
- Reduced advertising costs per patient.
- Faster connections with patients.
- The ability to finely segment and target only patients who are likely to be eligible.
- The potential to reach geographically distant populations who may still be able to participate.
- Unobtrusively reaching people where they're already spending their time (the majority of people go online at least once per day).
Patients found through social media can be targeted very specifically - this means that those who find trials online are much more likely to pass eligibility screening, saving time and money.
3. Increased Provider Involvement
In addition to contacting patients directly, reaching out to more providers is another effective method of increasing the number of eligible patients who are aware of trials.
Patients look to their doctors as the first and best source of medical information, including trials: 83% of people say a doctor's recommendation would influence their willingness to participate in a trial.
Luckily, most providers are receptive to educating patients about trials, and they do contribute about 20% of all patients enrolled.
Yet, their willingness to participate doesn't always translate into actual trail participants:
- 70% of nurses and 90% of doctors say they would share trial information.
- About 0.2% are actually doing so.
Again, this largely comes down to awareness and uncertainty about trial details and results.
About a third of physicians never get follow-up contact form pharma companies after referral, and many never see patient results.
This creates a breakdown of trust and reduces the chances that a provider will continue to refer patients to current and future clinical trials.
Increasing provider involvement requires both deliberate outreach and consistent follow-up communication, all of which can be managed through a CRM or other database-based technological solution.
4. Automate Screening and Communication Processes
Not all patients who are interested are actually eligible. The faster patients who aren't a good fit for a trial can be disqualified, the more efficient the recruitment process becomes.
In the past, this was all done manually. Now, it's possible to build self-qualifying steps and automate pre-screening into recruitment processes.
These solutions can be as simple as online qualifying surveys or more complicated, like built-in follow-up communications after an initial visit triggered in a CRM.
In fact, more than half of people (52%) say that receiving follow-up information during and after the completion of a trial would be very important to their decision to participate.
Technology which automates all or even some of these processes dramatically reduces the manual hours needed to qualify and screen potential candidates. This saves time for pre-qualified patients who are most likely to participate in a study.
5. Keep Track of Communications in One Place
Information received by patients is among the top reasons for continued participation in research.
For providers as well, staying top of mind and providing relevant follow-up information is key to ensure that both physicians and patients have access to all the information they need to make informed decisions.
Moving communications online can also reduce the perceived and actual burdens of participating in research:
- More than 55% of people say physical location research is a barrier.
- 53% say the number of required visits keeps them from participating.
- 49% say time commitment is the number one reason they avoid research.
Even if the inconvenience of traveling can't be fully eliminated, online communications can cut down on patients' time requirements and reduce the chance that they'll drop out of the study or fail to complete treatment regimens.
Centralized databases used to track communications can also serve as a central location to manage HIPAA forms, consent documents, and other compliance documentation.
Again, this record-keeping serves to save time and streamline consent and other pre-trial screening processes. They can also help increase the frequency and quality of communication between subjects and study personnel, reducing attrition.
Online Tools Lead to Faster Screening and Provide Cost-effective, Personalized Care.
Patient recruiting often looks like a leaky pipeline from initial contact through randomization, with potential subjects dropping out along the way.
Getting from initial contact through randomization quickly and cost-effectively means finding people who are a good fit and who are likely to engage, and monitoring them through the trial to minimize drop-outs.
As we've seen, this process is a lot more complex than it sounds.
Still, with the right implementation, a good CTMS (Clinical Trial Management System) solution lets you watch over and adjust the entire patient funnel from one birds-eye-view.
Advanced pharma software can also take a lot of guesswork and manual labor out of recruitment processes and performing diverse tasks like:
- Managing consent and HIPAA forms in one place.
- Tracking & improving the quantity and quality of patient interactions.
- Reaching more, and better qualified, audiences of potential research subjects.
- Reducing the time it takes to determine whether a potential patient is a good fir for a study.
- Reducing attrition during a trial.
- Following up with patients before, during, and after research.