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DEMYSTIFYING THE PERPLEXING WORLD OF CLINICAL TRIALS

By Helen Green, Vice President, Account Director, Langland USA

While clinical trials are essential steps in bringing life-saving, life-changing medicines to market, the trials themselves are inherently uncertain by nature. Clinical trial recruitment can be fraught with uncertainties; identifying qualified patients with specific conditions, ensuring their care and privacy, and following a patient all the way through the completion of a trial is rarely an absolute given. Due to the deep trust that exists between doctors and patients, a direct referral from an HCP is often the number one trial recruitment tool. However, for specific diseases and groups of people, communicating outside the familiar and reliable patient-doctor dynamic is essential for a trial to reach its recruitment targets.

For example, outreach beyond a study site’s database is often necessary for rare disease trials, for which individual sites may only see a few patients. In these cases, immediately broadcasting a recruitment message to the broader world opens up a pool of potential participants who otherwise would fly under the clinical trial radar because their physicians may not be aware of available trials.

Because of the scarcity of rare disease patients, many turn to online sources to browse the vast amount of information provided by rare disease advocacy and community groups as well as to social media channels to find other patients experiencing the same things they are.

Other groups often found online are pediatric and adolescent patients. While clinical studies can’t be advertised directly to children, parents of children dealing with the disease often reach out to other families in similar circumstances who are on the same journey. The need to share, find understanding, and belong to like-experienced communities are powerful behavioral drivers that apply as much to pediatric patients and their families as they do to rare disease patients.

Undiagnosed patients are a difficult, but crucial, third group to recruit. As more and more clinical trials seek to address diseases before they become problems, it’s important to find a way to identify patients before they even know or even realize they are patients.

HIT AND HOPE?

The principle of online outreach, then, is fine. What about reality? Recruiting patients for clinical trials using awareness, particularly digital media, can be a scary prospect for trial sponsors. Until recently, the promise has looked something like this: spend a potentially massive amount of money to reach a few hundred indifferent people, without ever understanding what combination of views, clicks, or form submissions is most likely to deliver an enrollment.

Fortunately for sponsors everywhere, that distinctly murky ROI story is increasingly a thing of the past. A mix of data, analytics, and technology can shine light into the dark hole of clinical trial advertising, ensuring close tracking and greater clarity on what clinical trial sponsors are getting for their money.

The power of digital marketing is its ability to be visible in the places patients are looking. Instead of traditional patient recruitment methods that target a broad audience — and therefore struggle to reach the right one efficiently — digital, people-based marketing can target the right people, at the right moment.

Using data and analytics across a mix of channels to create a 360-degree patient profile and a comprehensive patient journey, we can apply artificial intelligence, machine learning, and predictive analytics to anticipate patient behavior. People-based marketing can take millions of real patient behaviors and tie them together, creating a rich and accurate picture of a specific patient. High-value potential patients are identified and scored according to their predicted behavior and propensity to take part in a clinical trial, and also against a lookalike digital audience. This individualized picture allows us to focus with minute detail on small, hard-to-find patient populations at scale — which is perfect if the population you need is rare or undiagnosed.

THANK GOODNESS THE HARD BIT IS OVER

So now that you’ve identified your patients and made them aware of your trial, the job’s done, right? Time to sit back and plan the next one. Not at all; this is where the hard work begins. When a suitable patient knows about a clinical trial, that’s merely the first step on a long path of educating and nurturing them as a potential participant. It’s also the start of a partnership between the patient and the sponsor company that will continue to develop both during the trial, and after it finishes.

When patients are engaged through outreach, securing that first touch-point, it is not enough to ensure participation in a trial. In contrast to patients recruited through an existing relationship with the investigating physician, the next stage of the journey involves creating several contact points to help build relationships and nurture them along a pathway that leads to contacting a site and providing consent.

These touch-points should be a mixture of education and information and could include websites, animations, brochures, fact-sheets and guides to clinical trial participation. The aim is to introduce the concept of a clinical trial and explain what taking part will mean for the patient, so they have a basic grounding in the language of clinical research and the expectation on them before they even speak to an investigator. Patients who enter the initial discussions of a trial already informed in this way are much more likely to consent and remain on the study.

An ancillary benefit of leveraging outreach to identify patients and raise awareness of the study is the routing of patients through a website. In the digital age, this means a back-end tracking platform can be used to follow the progress of patients from the outreach that first brought the study to their attention, through to screening and randomization at sites, to supporting site burden along the way and identifying the exact ROI.

Through patient behavior on the website, you can identify pages or steps in the process where patients may need extra support or if there are specific eligibility criteria that are causing a high screen-fail rate, which could lead to a change in the protocol or in recruitment tactics. Sponsors also can use website performance data to identify sites that are recruiting well and following up with patients promptly, and those that aren’t, helping Clinical Research Associates (CRAs) to prioritize the time they spend with each site on their recruitment plans and targets.

A BANG FOR EVERY BUCK

One of the most significant benefits of being able to track patients through to randomization is identifying the return on investment (ROI) from the outreach spend, and being able to optimize against a successfully randomized patient, rather than just a visitor to a website.

It is at this point where patient recruitment campaigns differ from traditional advertising; the final marker of success is clear and definable — a randomized patient. The combination of ad concept, copy, imagery, and media placement that motivate the sort of person likely to follow the journey all the way to randomization may differ from the combination that appeals to people who are only interested in finding out more.

The ability to be more precise with targeting potential participants, and the flexibility to continually update and optimize that targeting, will ultimately improve trial performance, not just in the absolute number of randomized patients an outreach campaign can deliver, but also in the time to Last Patient In, and in the cost-per-patient.

Having such specific information about the kind of messaging and content that resonated with randomized patients during their recruitment journey can also help to support their journey through the trial. Further, it can be used to craft customized content for retention activities; creating a personalized experience for each patient.

Finally, the data and insights uncovered and collected throughout the recruitment period of a study can be instrumental later. For example, this knowledge can be helpful in constructing an outline of the typical randomized patient for future trials (and therefore helping to accelerate recruitment timelines and reduce start-up costs); in developing a demographic for commercialization; and to support disease awareness and drug-launch activities.

Ultimately, the intelligent use of data, analytics, and technology throughout the recruitment period on a trial can reap multiple benefits beyond reduced costs and shortened timelines. The information gleaned from a tracked and optimized media campaign can improve the ROI for a specific trial and also provide differentiating benefits to future studies and commercialization efforts.

The challenges of clinical trial recruitment have a tremendous effect on the bottom line; without the right patients there are no trials and without trials, no drugs can be brought to market. Poor patient recruitment contributes to the delay of over 80% of clinical trials; by far the most expensive step in the drug development process. However, this doesn’t have to be the case; when leveraged effectively, the alchemy of data, analytics, and technology can shine a light into this perplexing world.

Helen Green