Applied Clinical Trials
This article discusses best practices and benefits of keeping a trial top of mind at global sites, and measuring some of the qualitative and quantitative impacts it can have on a trial.
Aside from patients, there is no greater resource than sites themselves for running a successful clinical trial, and it’s amazing what can be achieved when we treat them well. This article discusses best practices and benefits of keeping a trial top of mind at global sites, and measuring some of the qualitative and quantitative impacts it can have on a trial. In this time of increasing competition for site attention, site engagement is an absolute necessity for sponsors to make their trial activities jump to the top of sites' priority list.
3 Benefits of Engaging Sites
Let’s explore some of the possibilities of a well-executed site engagement program. Put simply, ask yourself what you want your sites to do-then imagine them doing it better. That’s site engagement at a high level.
Specifically, clients tell us they have seen sites elevate performance in key metrics such as patient enrollment, patient retention, protocol compliance, data query resolution and overall study conduct efficiency (activation timelines, collaboration, transparency, etc.). These benefits and more are realized through three main strategies:
1. Creating a sense of ownership among global sites to get them invested from the beginning
2. Inspiring friendly competition and recognizing achievements to keep momentum going
3. Equipping sites with the information and tools they need to make their jobs easier so they can spend more time working directly with patients
As the name implies, site engagement keeps sites invested in the outcome of your trial in an effort to improve performance across the board. In short, it helps get the most out of your sites. It possibilities and reach are only limited by how it is used and what it is asked to do.
It Takes a Village
The younger generation of site staff who have come into their professional lives as seasoned technology users no doubt are frustrated and perplexed that something as important to our society as clinical research still relies on antiquated communication methods. Understandably, it must be challenging for them in these days of Facebook, Twitter, Instagram and so many more apps that make instant connections a breeze to stay engaged with an abstract sponsor running a trial that sends study information in a newsletter mailed once every few months. The information they receive is wildly out of date, unusable, not personalized to them, and is quickly forgotten.
By now, we likely all acknowledge that the days of quarterly newsletters being an effective method of communication are long behind us. In many areas clinical technology has a long way to go to catch up with other industries and certainly with the consumer technologies available on mobile phones study coordinators use daily in their personal lives. Fortunately, communication is one area where the clinical technology exists and is ready to serve when called upon. To be successful, a site communication solution should:
· Provide usable, personalized data relevant to each site recipient
· Be easy to access (ideally from emails) and intuitive to use
· Create a real sense of ownership and community-building
· Stay current with frequent content updates to bring people back regularly
· Feature Google-like search capabilities throughout the portal
· Include other valuable solutions in one place (e.g. documents, training modules, contacts, visit guides, etc.)
The goals of using an online communication platform go far beyond sending out required information. When properly implemented with a consistent and appropriate sending schedule, you can ensure sites read your messages, enable your monitors to follow up with sites that don’t, and create a consistent contact program that keeps your trial top of mind so sites prioritize your study activities above all others.
At its core, a communication platform needs to send required information to sites, such as an announcement of a protocol amendment being released, drug resupply instructions, or updated hours of study team availability. While important for relaying information, this type of logistical email does not create meaningful mindshare at sites.
Make it a Team Activity
Some DrugDev customers have successfully inspired sites by running campaigns that promote awareness activity and team building. For example, one Top-10 pharma company used the platform to promote a “Wear Orange” campaign in support of Melanoma Monday. Sites were encouraged (but not required) to take team photos of their staff wearing orange and post them to the network, where they were shared with other sites involved in the trial. In addition to showing patients at the clinic that day how much the staff cares about their condition, it creates a bond between the site and the study sponsor as they are working together to combat the same enemy. This type of awareness spreads word of mouth within study sites and increases their sense of ownership in the outcome of your trial.
Think Like a Gamer to Improve Clinical Research
Imagine for a moment you are playing a video game, except it doesn’t show you your score-or maybe it does, but lacks any context of how that compares to other players-and whenever you complete a level there are no bonus points, rewards or fireworks above the castle. You simply move onto the next task or activity without fanfare. This doesn’t sound like a particularly engaging game, so why would you play it? Yet that’s how many sites must feel when they participate in clinical trials.
Comparing the fun and frivolity of video games to something as serious as clinical research may not be entirely appropriate, but the key concepts definitely apply. Without a proper site engagement program, sites likely have no concept as to how well they are performing on a daily basis when it comes to key measurables such as screening, enrollment, patient retention and data query resolution. Worse, there’s a good chance they only hear from monitors when there’s a problem to discuss.
Good Natured Rivalry and Recognition Encourage Site Performance
Applying some of the concepts of gamification in a professional manner can bring fresh life to site energy and activity levels throughout the trial. Some systems use site-specific metrics to show staff how they are doing compared to other sites in their country and across the trial over time.
These powerful data are presented on leader boards which are regularly updated and emailed to the entire virtual site community. Perhaps unsurprisingly, these emails consistently earn the highest open rates from Principal Investigators in particular, who relish the friendly competition of seeing their site climb the leader boards-and ensure study coordinates receive the same message and goals.
Merit Badges Aren’t Just for Scouts
It's only natural the inherent satisfaction of being told “job well done” keeps people motivated to continue performing well. Site engagement should be used to allow study teams to centrally manage (and automate the distribution of) reward badges for individual staff profiles when certain milestones are achieved. For example, a Silver badge may be sent when the site completes activation requirements, and a Gold badge when the site enrolls the first patient in country.
It’s extremely refreshing for site staff to receive positive feedback, especially when badges are accompanied by personal notes from the study team, thanking them for their hard work and accomplishments. Receiving a badge rewards behavior you want from sites, and inspires them to work hard to earn more. It's also a source of pride-in fact, sponsors tell us they have often seen badges printed and displayed in site offices!
Solving Enrollment Problems in 30 Days
Infinity Pharmaceuticals is among DrugDev clients that have combined news, leader boards and badges into awareness campaigns aimed at specific goals. In this case, Infinity was behind enrollment goals heading into year-end holidays and decided to implement a 30-day challenge using the DrugDev Spark™ unified clinical suite.
The concept was simple and highly effective. Infinity developed badges where certain achievements like screening a patient, enrolling a patient, etc. were worth a set number of points. Leader boards were sent at least weekly, and at the end of the 30 days Infinity made a donation to a relevant patient advocacy group on behalf of the site with the most points.
The response was tremendous. Enrollment rates more than tripled over the prior month and remained elevated for the following months as well. It worked so well Infinity repeated the challenge again later in the trial with similarly impressive results. It’s just one example of the power and ability of site engagement techniques that inspire sites to improve performance for critical objectives.
Simplify Life for Your Global Sites
Of course, a site engagement program is only effective if sites actually use it. Ensuring adoption hinges on many factors including several mentioned earlier such as valuable content and intuitive usability. Sites do not want “yet another system” to log into. Rather, they want to log in directly from an email, ideally with single sign-on, and get real value from what they find there. It needs to become a habit as they start their day, and a trusted resource they turn to when they have a question about the trial-and only a few minutes free to get the answer and act on it.
Modern Technology Platforms Makes the Site’s Life Easier
That’s why the best site engagement portals aren’t site engagement portals at all. They are clinical trial optimization systems or unified clinical operations suites or whatever you want to call them. The important part isn’t the name; it’s the utility that matters.
What makes today’s unified clinical suites stand out is they do much more than site engagement, as important as that is. They are document exchange repositories, learning management systems, site payments platforms, eConsent solutions, site activation systems and more. They are a unified one-stop-shop for sites to get everything they need to run the trial efficiently in one centralized and convenient location.
And they can be even more than that by providing sites with support tools that make it easy for them to run the trial, such as visit guides, scheduling and dosing calculators, FAQs, contact directories and more. Site collaboration also can be improved with tools for study teams including dynamic eTrackers that monitor and analyze incoming data from other systems (CTMS, EDC, IVR, labs) to proactively solve key challenges like enrollment diversity, patient retention and closeout visit scheduling.
By enhancing their value with complementary features that make site lives easier, these platforms are transformed from traditional portals into comprehensive clinical trial solutions sites and study teams alike want to use every day.
Communicate, Motivate, and Inspire Your Sites
Sites are the shared resource upon which all sponsors, CROs and studies rely. We have a collective responsibility to make their lives easier while treating them as partners, not employees, and to inspire the best performance from them. In this time of protocol complexity and increased competition it’s no longer acceptable to continue doing things the same old ways. The industry must come together to ensure proper communication, motivation and inspiration, and support for sites using modern technology. I hope you agree that not only is it the right thing to do, but it also can pay real dividends by improving key metrics for global clinical trials.
Kristopher Sarajian is Vice President of Marketing, DrugDev
Kris Sarajian can be reached at firstname.lastname@example.org