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Could Gamification Improve Clinical Trials?

by Jae Chung
12Dec2016

The gamification of many aspects of our culture is well under way, and some researchers are even beginning to consider the integration of gamification principles into clinical trials.

Could Gamification Improve Clinical Trials?

On August 31, 1935, a legendary Russian coal miner named Aleksei Grigorievich Stakhanov mined 102 tons of coal in less than 6 hours, which was an astonishing 14 times his quota. Seeing an opportunity to use this amazing feat to their advantage, the Russians started a movement called Stakhanovism, which was designed to increase the productivity of steel workers across the country. Every year, the soviets would recognize and reward the greatest producers of steel, resulting in worker productivity increasing by 82% by 1937. Stakhanovism is an example of a strategy that leveraged the basic human desire for recognition and competition to improve worker performance.

There has been a long history of using things like fun, play and competition to motivate people and make work seem more enjoyable and productive. While gamification as a concept has been around forever, the term was first coined by Nick Pelling, a British computer programmer and inventor, in 2002. By 2010, use of this term in business culture began to accelerate rapidly, and in 2011, Gartner added gamification to their hype cycle.

Gamification Defined

Gamification is the application of game design principles and techniques to non-game contexts, with the intention of creating value for the players and other stakeholders. In recent years, gamification has become more popular as an online marketing technique used to encourage engagement with a product or service. Gamification techniques strive to leverage people's natural desires for rewards, achievement, status, altruism, community collaboration, and more, in order to drive desired user behaviors that are advantageous to stakeholders.

Gamification in Business

One of the first modern day business examples of gamification was airline frequent flier miles programs. More recently, Starbucks has used gamification principles to create one of the most successful loyalty programs in the world. Members accumulate points as they make payments, and redeem those points for free food, drinks, and drink refills; achieving higher levels of membership in the process. Additionally, the program randomly provides customers downloadable songs and freebees to increase engagement. The success of this program is nothing short of extraordinary. According to the company, Starbucks loyalty members spend three times as much as non-members.

Gamification in Health Care

One increasingly popular example of gamification in the healthcare industry is activity trackers. Typically worn around the wrist, these devices are used to drive healthy habits and behaviors. Activity trackers like FitBit Flex, for example, use a wristband hardware device and a web app to log some basic activity information throughout the day, without the need for any user intervention. Specifically, the Flex can measure steps taken, floors climbed, calories burnt, and distance traveled. In night mode, it can measure movements during sleep to give you a basic indication of how many times you awoke, how long you slept for, and the overall quality of your sleep. There are a number of gamification aspects to the Fitbit Flex:

  • Allows you to set daily fitness goals
  • Instance feedback on progress towards your goals
  • Ability to earn cash rewards

Using the Fitbit Flex, consumers can maintain greater awareness of their activity level and are more empowered to engage in desirable behavior.

Gamification is also being used to spur scientific advancements that fuel the drug discovery process. To understand how a protein works and target it with drugs, you need to know its structure, but determining protein structures is very difficult. The online game Foldit is a puzzle-like game that scores players based on the structures of the proteins they have folded, thereby using human puzzle-solving ability and competition to attempt to predict the structure of proteins. In addition, Foldit also allows players to design new proteins that could help to prevent or treat diseases.

Gamification in Clinical Trials

In the pharmaceutical industry, companies have begun to use gamification to improve relationships with patients by using games to encourage disease management. Sanofi launched an app for children with Type 1 diabetes that educates them on the disease, as well as another app called "Monster Manor", which encourages players to regularly test and record their blood glucose levels. In addition, Boehringer Ingleheim, in collaboration with Eli Lilly, launched an app called "Complications Combat" to educate patients on behaviors that can exacerbate their conditions.

In the context of clinical trials, gamification presents an excellent opportunity to improve performance and reduce costs. There are a number of areas that hold promise:

  • Patient recruitment: Today nearly 80% of clinical trials fail to meet enrollment timelines, and up to 50% of research sites enroll one or no patients. This is in part why so many studies fail. If nothing else, these issues dramatically drive up costs and extend timelines. According to research conducted by the National Cancer Institute (NCI), nearly 40% of oncology trials failed to achieve the minimum patient enrollment (in Phase 3 studies, the failure rate jumps to more than three out of five). Research published by Sully et al in 2013 looked at publicly funded clinical research studies in the UK over a seven-year period shows a similar trend. They report that only 55% of trials recruited their originally specified sample size, 78% of the trials recruited 80% of the original target, and almost one third of trials received an extension of some kind. What is behind the patient recruitment challenge? While patients often enroll in clinical studies for altruistic reasons, many are not aware of the opportunity to participate in studies or have false perceptions about participation. Gamified clinical trial apps can help to educate people understand the clinical trial process by explaining in a much more digestible or interactive way the benefits of participating. Games provide a fun and engaging approach to learning and have been used to provide information about clinical trial participation with an aim to helping users understand common reasons for and against participation, dispelling myths about clinical research, understanding the purpose of clinical trials and what is involved in participation, and knowing the benefits and drawbacks of participating. Patients can even be rewarded for signing up by either earning material rewards or simple visual feedback (starts, badges, etc.).

  • Retaining patients in clinical trials: In addition to recruiting patients, keeping them engaged in study participation is critically important to the success of a trial. According to ICON, studies typically experience dropout rates ranging from 15 to 40%. Oftentimes, patients drop out due to loss of interest or engagement with the study, or because they find study participation too burdensome. For these reasons, pharmaceutical companies are considering gamification to make clinical trial participation more convenient and patient centric. Games can provide a more fun, interactive and engaging experience, encouraging patient retention while collecting vital data and information that can be used to measure the effects of drug treatment. Examples of how this has been piloted in clinical trials include using games to: educate patients about clinical trials, measure health outcomes, and increase patient engagement. One notable example that has been used to measure health outcomes in muscular dystrophy patients is the ACTIVE-Seated (Abilities Captured through Interactive Video-based Evaluation) application. It uses the Microsoft Kinect gaming interface to gather positional information about an individual's upper extremity movement to determine functional reaching volume, velocity of movement, and rate of fatigue while playing an engaging video game. In muscular dystrophy, individuals undergo progressive loss of muscle strength and function, and the game (which is played while seated) has enabled the development of an objective outcome measure in patients unable to walk.

  • Patient compliance: To participate in clinical trials, patients need to learn new habits around clinical trial protocol requirements. For example, subjects might need to take an investigational medication or complete a diary at a specified day/time. Gamification can be used as a behavioral modification tool, helping subjects create new habits that improve patient compliance. As an example, consider a recent HealthPrize Technologies' study which showed that gamification efforts resulted in a 54 percent increase in prescription fill rates, and often led to prescriptions being filled more frequently. Patients with acne, diabetes, hypertension, and asthma/COPD logged onto HealthPrize’s mobile and online platforms an average of 4 times a week to keep earning points and rewards.

  • Disease research: Gamification could also play a role in helping pharma diagnose and determine the severity of certain diseases. In early 2014, for example, Pfizer teamed up with Akili Interactive Labs to conduct a clinical trial using the video game "Project Evo" to detect early signs of Alzheimer's disease. The game challenges patients to navigate a series of obstacles as researchers determine how well users can pay attention and make decisions when confronted with other distractions. The hope is that this trial will eventually lead to deploying the app as an early detection tool for Alzheimer's.

  • Investigator and site training: The Deloitte Learning Academy (DLA) case study provides a good template for how gamification can improve the effectiveness of Investigator and Site training by using missions, badges and leaderboards alongside videos, in-depth training, quizzes, and tests to encourage participation and a sense of competition.

  • Improving site performance: Sponsors are looking to innovative methods such as rewarding sites with badges as they pass certain pre-determined milestones (e.g. ten patients screened, all training completed) or using leaderboards to show sites how they are performing relative to their peers. Principal investigators are motivated by watching their site on the leaderboard to see how it ranks on key metrics such as patient enrollment and data query resolution. Meanwhile, exposing clinical trial teams to metrics, leaderboards, and other activities as they undertake everyday work can potentially improve both performance and quality. Inspiring friendly competition can motivate global site performance for areas such as activation, patient enrollment and more.

Conclusion

Can gamification really be used to drive greater innovation and efficiencies in clinical research? Current empirical research on gamification largely supports the view that it does produce positive effects, but many caveats exist. In particular, confounding factors such as 1) the role of the context being gamified, and 2) qualities of the users – have a significant impact on success. The research also suggests that sporadic use might not be compatible with promoting gamification, because users might not spend enough time with the subject in order to become interested. A recent study that reviewed a number of gamification efforts suggests that, "The impact of the context of the gamified system should be examined by experimental conditions. By implementing certain motivational affordances and holding them constant while varying the nature of the underlying service could give insight into how the context affects the outcomes of the gamification." Meaning more research is necessary. In this case, the "service" is some aspect of the clinical research value chain that you want to expedite using gamification (e.g., site performance.) "Motivational affordances" refers to how we motivate the users involved. We don't know, for example, how sites will respond to a leaderboard showing cycle times of other sites. Will that motivate people or frustrate users and impede progress? The only way we will know is if sponsors and contract research organizations (CROs) with investigative sites are willing to step up and give it a try. Given the current enrollment and retention metrics for clinical trials, what do we have to lose?

Article originally published in Applied Clinical Trials, November 2016

Jae Chung
JAE CHUNG
President and Founder
goBalto, Inc
Jae Chung is the president and founding visionary of goBalto. A startup evangelist, Chung wants to change the way pharma and CRO companies initiate clinical trials. goBalto's purpose-built study startup SaaS solution allows stakeholders to better adhere to established timelines and budgets, with customers reporting reduction in cycle times by 30-plus percentage, thereby getting medicines to those in need faster.

Chung works with Rock Health to mentor healthcare technology startups, and previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company. Prior to Celltrion, he worked as a strategy consultant with McKinsey & Company.

In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has experience in drug development, commercialization, and business development. He has an MBA from New York University and holds a CPA.

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