Co-authored by Dinesh Kashyap

If you’ve been involved in a start-up of a clinical study, you’re probably aware of the challenges that come with patient recruitment. 

What is the scope of patient recruitment in clinical trials?

Patient recruitment is one of the biggest bottlenecks in clinical research. According to the National Institutes of Health (NIH), more than 80% of clinical trials in the United States fail to meet their patient recruitment timelines. These delays increase costs, deplete resources, and prolong the time to market introduction.

Patient recruitment compromises about thirty percent of the entire clinical trial management process. It also is the most time-consuming aspect of the clinical trial process making it a leading cause of missed deadlines. However, effective dealing with patient enrollment and retention challenges in clinical trials offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce the time to market. 

Patient-Facing Website

A patient-facing study website provides patients and participants with a comprehensive list of actively recruiting studies across different therapeutic areas and disease conditions. This website allows the patient journey to be broken down step-by-step across the recruitment process.

Providing a platform where your patients can engage and benefit from useful study information is critical for any Patient Recruitment endeavor. 

An all-inclusive patient website can provide information on studies that the patient is participating in along with other important study details such as:

A patient-facing website can also digitally enhance patient engagement by allowing patients to have easy access to their personal lab tests and other electronic health records. The use of chatbots where your patients can connect to available recruiting agents and nurses in just a matter of minutes can augment your patient-facing website to provide a better patient experience.

This, in turn, directly correlates to increased patient retention and creates an environment where the patient is at the center of the clinical trial process.

With patient experience being the crux of conversation in the healthcare and clinical research industries, a patient-facing website is an absolute necessity to have if you’re striving to create a patient-centric experience and improve your recruitment process.

The following diagram provides a high-level overview of comprehensive patient requirement capabilities which can be enabled with the augmentation of digital technologies.

Here is the breakdown of patient recruitment activities which can be managed and streamlined through a patient-facing website.

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Study Search & Registration: In this first step, the patient searches for areas of interest including ones that pertain to his or her own medical concerns or their loved ones. Prior to registration, the participant gains complete transparency of the trial and can enroll with confidence. For each study, the patient views the study details such as overview, benefits and risks, eligibility criteria, and opts to take the phone-screen online or through traditional means. In addition, this step allows the patient to self-register, where the privacy of their personal information is ensured.

Online Pre-Screen: When the patient selects the option to take an online pre-screen, he or she will be directed to a specific pre-screen questionnaire which is based on branching logic. The user-friendly phone-screen provides guided questions and requests responses based on the patient’s inputs. The questionnaire notifies the patient on study eligibility upon completion of the questionnaire.

Nearby Recruiting Sites List: Once the patient is qualified, the website provides a list of active clinical sites based on the patient’s location.

Site Details: When the patient selects a site, the site detail page provides information on the site’s address, contacts, and information on the principal investigator. Site details also provide the location of the site on a map.

Appointment Booking: The patient, then, books a screening appointment at the site which is most convenient for them.

Travel & Hospitality Request: The patient may also request travel and hospitality if such services are offered by the sponsor, CRO, and/or site.

eConsent: The patient fills out eConsent forms prior to visiting sites for pre-screening. An eConsent delivers benefits through an easy-to-read questionnaire and learn more about the study. Filling out each consent question is performed at the convenience of the patient’s home. An eConsent offers participants the chance to review materials as often as they wish, giving them time to reflect on their choices over time. In advance of conversations with staff, prospective and active participants can bookmark any aspects of the study they may wish to discuss further. 

More details on the benefits of eConsent are available here. 

Appointment Confirmation: Upon successful completion of the appointment booking, the patient receives an appointment confirmation email along with screening preparation requirements such as optimal fasting windows, time of arrival, and duration and details of the screening process.  

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How Technology Can Be Leveraged To Bolster Patient Recruitment Activities 

Organizing and managing your leads, keeping track of lead communication, and ensuring you’re screening enough volunteers can get tedious. Relying on outdated recruitment tactics such as physician referrals and mass-media advertising is proving to be costly. Recruitment deadlines are being extended and studies are being over-budgeted. However, by adopting the latest tools in the market, recruitment teams can manage their activities in a seamless and streamlined manner. 

Here are the six best technologies that can help boost your patient recruitment activities. 

Computer Telephony Integration (CTI)

It’s important for recruitment teams to have a robust and effective call center so they can effortlessly track customer interactions across multiple channels such as voice and chat. With this in place, they no longer have to dig through different mediums to organize lead communication as it happens automatically.

There are numerous players in the market that offer CTI but one worthy of mentioning is Amazon Connect, an intuitive cloud-based customer contact center that takes just minutes to set up. It’s built to support small and large-scale businesses and can be configured without technical support.

Connect also uses artificial intelligence speech recognition to convert text to speech in multiple languages and even speech-to-text. This can be extremely helpful if your study is multi-racial or multi-ethnic. Language is no longer a barrier to producing messages and advertisements that leads can easily understand. This is a great way to improve patient experience, which, in turn, can help increase patient retention. 

In the industry today, a huge challenge is targeting high-probability volunteers in a population that is fit for your study. With a solution like Connect, you can automate outbound calls to target a specific segment of the population. Agents can queue phone numbers and schedule automatic appointments, reminder calls, and payment notifications based on set criteria. Strategies like this can save your recruitment teams tons of time, effort, and money.

The apt solution would integrate right into your CTMS and allow agents to control and manage all their recruitment activities in one place without having to log into multiple accounts.

Adopting a comprehensive tool to amplify patient recruitment is becoming an industry standard. Sponsors, CROs, and sites have an edge over their competitors who may be stuck using legacy systems. 

Chatbots

Leading chatbot services provide both the ability to build customized computerized bots that use deep learning, speech recognition, and accomplish tasks in an easy-to-use manner. One of the best use-cases for this in the clinical trial recruitment space is for the pre-screening of volunteers, an undisputed area of challenge.

The chatbot replaces a human recruiter and intelligently understands the sentiment of the user. It’s interactive, intuitive, and allows volunteers to instantly know if they are eligible for participation. Chatbots can also assist in filtering out unqualified leads and write those inputs back into your CTMS. Also, the use of chatbots can eliminate back and forth communication by providing real-time responses to commonly asked questions.

Additionally, using a chatbot can bring consistency and eliminate human error during the screening process.

It may seem as though this may not be a necessity but the industry is shifting towards a fully digitized, process-driven mentality. Sooner or later, traditional methods of recruiting will be obsolete. 

Programmable SMS

Another prerequisite to scaling your patient recruitment digitization efforts is a programmable SMS solution. A unanimous choice, Twilio is the market leader in this space. One of their popular products allows customers to send email and text message campaigns to a large targeted population. Additionally, utilizing tools such as Twilio provides the ability to schedule automated blasts to high-volume patients. This makes it easy to personalize communication with your patients and keep them in the loop regarding upcoming studies, promotions, and other study-related information. 

When your agents are dealing with high-volume patients, ensuring high deliverability and low fraudulent activity can be a major challenge. In fact, Twilio works with major network providers and uses intelligent messaging to ensure these challenges are tackled. Recruitment teams can use customized short codes to allow patients to quickly connect and recognize your brand. 

Here are three specific ways you can augment a programmable SMS/push notification service into your patient recruitment process:

1. New Study Recruitment — Using programmable SMS can allow you to provide important study details for subscribed patients where they can be notified when selected studies open up for enrollment.

2. Pre-Screen & Appointment Scheduling — Your patients can fill out pre-screen questionnaires right through their messaging apps on their mobile devices and they can also automatically schedule appointments based on availability.

3. Confirmation & Reminder Notification — With the setup of an SMS solution, your recruitment agents can confirm patient appointments based on configured automated workflows. This medium can prove to be a handy tool for appointment instructions and reminders such as fasting information, directions to the site, and other visit related details.

There’s a myriad of leading solutions in the market that can help with your patient recruitment needs. When choosing your solution, it’s important to consider the patient’s experience. There’s no single best solution out there so it’s important to do your due diligence before deciding what is best for your patient recruitment needs. Providing clear and concise communication to your patients can not only increase your recruitment metrics and save costs, but it can also contribute to higher patient retention. 

A Truly All-In-One Platform

The use of the latest technology can indeed help your recruitment efforts when it comes to saving time and money but it’s also important that you’re considering every aspect of your clinical trial service operations.

Once patients enroll into a clinical study, the emphasis shifts to retaining patients in the trial and ensuring they are compliant with all the aspects and timelines of the protocol. 

It’s tough to choose just one tool that offers everything you need. This is why it’s crucial to select one centralized platform which can handle all your clinical trial needs but one that also fluidly integrates into other solutions.

To address some of the challenges in this space, a tool that can provide comprehensive capabilities can truly help you streamline your clinical trial processes. Below are some core capabilities that you should look for when choosing your all-in-one clinical trial management platform. The ability to: 

• handle multiple studies and sites at once;
• screen volunteers through template-based screening questionnaires;
• track demographic information through pre-screening;
• manage and track multiple site budgets that roll up to the study level;
• track and provide real-time visibility of enrollment metrics;
• schedule automatic appointments based on a certain event(s);
• store contact information and communication logs of all leads;
• ensure leads have the option to opt-out;
• run various types of recruitment campaigns;
• integrate with external systems such as a CTMS, IRT, EDC, or an eSource which can provide real-time data capture for screening and subsequent visits;
• integrate into EHRs and EMRs to pull in relevant patient data in alignment with the inclusion and exclusion study criteria;
• and match participants using artificial intelligence to appropriate studies considering the study’s inclusion and exclusion criteria and participant’s demographics and medical conditions

are some of the features which can make your recruitment process effortless. 

Along with these essential features, there are a couple more that are worth highlighting:

eConcierge: When patients arrive at the site for their appointment, ID verification is one of the most time-consuming activities that eats up screening staff time and increases patient wait time. With an eConcierge digital solution, check-in and ID verification can be automated. The patients provide their identification through facial recognition software where the interface automatically pulls up their information. Then, the screening staff gets notified that the patient has arrived and has checked-in.

Robust and Flexible Reporting & Analytics: The ability to run real-time analytics through reports and dashboards is the icing on the cake. Recruitment teams can obtain insightful recruitment metrics and KPIs across various recruitment processes in the organization. Key metrics such as:  

can be tracked for every campaign and source/channel to enable value-add decision-making in your organization.

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Conclusion

As multiple stakeholders are involved in the patient recruitment process including sponsors, investigators, recruitment specialists, clinical research teams, and patients themselves, the strive to increase patient enrollment numbers requires effective and efficient communication and collaboration. 

A lack of patient awareness results in a lack of participation, ultimately leading to study delays and higher overall costs for a trial. Now more than ever, sponsors, CROs, and sites must find alternate ways to reach both their desired demographic and enrollment goals for their study if they want to accelerate enrollment and elevate patient retention. 

With a well-strapped, comprehensive solution, you can ensure you’re on the right path to upgrading your patient recruitment to the next level.

References:

• https://aws.amazon.com/connect/

• https://clinicaltrials.llu.edu/sites/clinicaltrials.llu.edu/files/docs/current-challenges-in-clinical-trial-patient-recruitment-and-enrollment.pdf