TrialeX

Despite the existence of over 434,000 registered clinical trials globally, a staggering 80% of these trials fail to meet their enrolment timelines, causing significant delays in translating promising laboratory research into life-saving treatments. These protracted timelines not only impede the efficient utilisation of funding but also prolong the time it takes for new treatments to reach patients in need. The underlying cause of poor recruitment and retention of participants is a lack of education and awareness surrounding clinical trials in the general population. Our market research uncovered a profound lack of public understanding about clinical trials; 74% of the public knows little or nothing about clinical trials, and 95% do not know where to access clinical trial information. This knowledge gap leads to a staggering 90% of clinical trials struggling to recruit participants, resulting in over 30% of trials failing solely due to ineffective recruitment and retention. 

Moreover, the lack of education and accessibility exacerbates the issue of diversity, equity, and inclusion (DE&I) in clinical trials. Over 41 under-served groups in clinical trials have been identified by the NIHR. These systemic healthcare challenges stem from underlying issues ingrained within the educational system. The absence of robust education initiatives has contributed to a pervasive lack of public knowledge and awareness regarding clinical trials allowing historical mistrust to grow within under-represented communities. Despite the public's eagerness for a better and fairer healthcare system, they remain unaware of their potential to drive this change. Meanwhile, the efficacy and safety of treatments that may differ among population subgroups depending on factors, including sex, age, race, ethnicity, lifestyle, and genetic background often remains unknown. Historically, clinical trials have focused on white, male participants, leading to a striking misrepresentation of the world demographic. For example, in 2020, 53 novel drugs were approved by the FDA through CT’s amassing 32,000 participants, 75% of which were white. This homogeneity poses risks, as medications are released to populations that have not been adequately tested, potentially resulting in ineffective or dangerous treatments for millions of people.

The inefficiencies in recruitment and retention are not only a social and academic injustice; they are exceedingly costly. Clinical trials consume a significant portion of the 10-15 year, 1.5-2.0 billion USD development cycle required to bring a single new drug to market. Thus, a failed trial incurs substantial financial losses, ranging from approximately 800 million to 1.4 billion USD. These financial resources could be better utilised for further clinical trials and pre-clinical research.

TrialeX offers an integrated solution to address these challenges comprehensively. By educating the public, raising awareness, and fostering trust within communities, we facilitate easy access to trials for all communities. Our platform aims to improve recruitment, retention, and overall trial management, thereby enhancing the efficiency, effectiveness, and diversity of clinical trials. Through these efforts, TrialeX seeks to drive positive change in healthcare and contribute to the advancement of medical research and treatment, whilst advancing health equity.

TrialeX is an innovative platform aimed at transforming the landscape of clinical trials to improve participant recruitment, retention, management, and diversity ultimately facilitating the development and accessibility of life-changing medical treatments for individuals worldwide.

Central to our solution is addressing the education gap surrounding clinical trials, particularly among under-served communities. TrialeX stands out as the sole platform placing education at the forefront of the recruitment and retention process. While other solutions primarily focus on enhancing recruitment for clinical trial teams, we recognise the pivotal role of the public in recruitment. The educational aspect of our platform is driven by an algorithm which recommends tailored educational content. By harnessing user data we curate personalised resources resonating with diverse audiences and learning preferences. This ensures that individuals from all backgrounds grasp the significance and advantages of clinical research effortlessly. We not only prioritise educational initiatives and awareness-raising but also incentivise users for learning about trials and the science behind them. Our gamified approach not only makes learning enjoyable but also rewards users, fostering engagement and inclusivity.

Once users are well-informed about clinical trials, TrialeX facilitates seamless exploration and participation through a user-friendly interface. Our platform features a sophisticated filtering and recommendation system, allowing users to easily discover and join trials with a simple click on their mobile devices. Moreover, TrialeX enables direct communication between users and trial teams, promoting transparency and enabling participants to ask questions about the trial process.

For scientists overseeing clinical trials, TrialeX offers a comprehensive trial management system, providing detailed insights into the demographic composition of the participant pool. Leveraging predictive analytics, TrialeX can anticipate participant dropout rates and offer proactive strategies to mitigate risks, ensuring a personalised and engaging experience for trial participants and reduced dropout rates and improved efficiency for trial scientists.

Overall, TrialeX represents a transformative solution that combines education, engagement, and technology to address the challenges of participant recruitment, retention, and diversity in clinical trials. By empowering individuals with knowledge and facilitating seamless trial participation, TrialeX is poised to drive meaningful advancements in medical research and healthcare accessibility. We strive to create a more equitable and accessible healthcare ecosystem where everyone has the chance to benefit from cutting-edge medical treatments and contribute to scientific progress.

TrialeX serves a diverse range of individuals, aiming to democratise access to essential information about clinical trials and research opportunities that could positively impact their lives or the lives of their loved ones. Our platform prioritises inclusivity and diversity, ensuring that everyone, regardless of their background or circumstances, has equal opportunities to engage with and benefit from clinical research. Currently, there are over 41 underserved groups in clinical trials, spanning various demographics such as women, refugees, older adults, ethnic minorities, individuals from low socioeconomic backgrounds, people in full-time employment, and LGBTQ+ individuals. These groups, representing millions of people worldwide, often face barriers to participation in clinical trials due to a lack of awareness, accessibility issues, or systemic inequalities within the healthcare system. As a result, they may miss out on potentially life-saving treatments or opportunities to contribute to medical advancements. Therefore, our target population encompasses people from all walks of life, including those who have historically been under-served or marginalised in the realm of clinical research.

While our initial pilot program is based in the UK, our long-term vision is to expand globally, recognising that disease knows no boundaries, and access to clinical trials should be universally available. By reaching under-served populations and empowering them to participate in clinical research, TrialeX aims to make a tangible difference in improving health outcomes and advancing medical knowledge on a global scale.

Our team at TrialeX brings a comprehensive understanding of the challenges inherent in clinical trials, not only from the perspective of participants but also from the viewpoint of clinical trial scientists. As clinical scientists who have conducted trials ourselves, we have firsthand experience with the complexities and obstacles involved in recruiting and retaining participants. Furthermore, each member of our team represents diverse backgrounds and demographics, including individuals who belong to under-served groups in clinical research. This diversity within our team allows us to bring a wealth of perspectives and lived experiences to the table, ensuring that our solution is inclusive, empathetic, and tailored to the needs of the communities we serve. This dual perspective allows us to appreciate the multifaceted nature of the problem and develop solutions that address the needs of both trial participants and researchers.

Our team is also deeply passionate about engaging with people and learning from their lived experiences. We prioritise community input and involvement in the design and implementation of our solution. For example, we won a community enterprise award for conducting extensive interviews with members of under-served groups to gain insights into their perceptions, concerns, and needs regarding clinical trials. These conversations have been instrumental in shaping the development of our platform, ensuring that it addresses the real-world challenges faced by our target population. We strive to continue having these hard hitting conversations throughout the development and implementation of the platform. 

Furthermore, our commitment to community-driven solutions is reflected in the values that underpin our company. We believe in transparency, equity, and empowerment, and these values guide every aspect of our work. From the design of our platform to our outreach efforts, we strive to centre the voices and experiences of the communities we serve.

We have made significant progress in the development and testing of TrialeX. Our team has successfully designed and refined the UI/UX of the user and customer interfaces to ensure ease of navigation and accessibility. In addition to UI/UX development, the backend infrastructure and AI algorithms that will power the platform are under development. 

We have conducted over 200 interviews with clinical trial academics and members of the public. These interviews have provided valuable feedback that has informed the UI/UX design, leading to multiple iterations and improvements based on user input. The high level of interest expressed by 90% of customers and 81% of users demonstrates significant demand for our platform once it is fully developed and launched.

We have secured our first paying customer from the Surgical Intervention Trials Unit (SITU) at the University of Oxford. The customer has provided a substantial contract for his latest trial, which spans 20 different sites in the UK and Australia. This partnership demonstrates early validation of our solution within the clinical trial community.

Finally, we received a £500 community enterprise award from Oxford Hub, enabling us to conduct an in-depth study on diversity, equity, and inclusion in clinical trials. Through this study, we collected valuable insights on the perceptions and experiences of clinical trials, particularly among under-served groups. Our recruitment strategy for this study was highly successful, with over 150 sign-ups within 24 hours, indicating strong interest, trust and engagement from under-served communities worldwide.

MIT Solve can help us overcome several barriers that we currently face:

• Assistance with code reviews and optimisation for both the mobile and web applications. 

• Guidance on making the platform available on both Android and iOS 

• Legal advice on patenting our AI algorithms to protect our IP

• Assistance in developing a repeatable sales strategy that speeds up the sales cycle and is tailored to different customer segments e.g. academic, commercial, and biotech start-ups.

• Advice on effective marketing and social media strategies to improve public engagement and enable conversion to users, ensuring reach of diverse user segments.

• Help with gaining exposure to potential investors and to utilise media channels to enhance recognition in the public eye enabling us to foster partnerships and collaborations.

TrialeX stands out as the sole platform placing education at the forefront of the recruitment and retention process. While other solutions primarily focus on enhancing recruitment for clinical trial teams, we recognise the pivotal role of the public in recruitment. The educational aspect of our platform is novel and is driven by an algorithm that we hope to patent, which recommends tailored educational content. This educational content is linked to our marketplace of clinical trials, making it easy for users to find trials they are interested in, aided by personalised recommendations based on user data. This approach not only simplifies the process of finding relevant trials but also empowers users with knowledge about the purpose, procedures, and potential benefits of participation.

A standout feature of TrialeX is our in-app chat system, facilitating direct communication between scientists and participants. This real-time interaction enhances participant engagement and fosters transparency and trust within the research community.

Furthermore, TrialeX incorporates a trial review capability, enabling participants to provide feedback on their trial experience. This feedback loop allows researchers to refine protocols, enhance trial design, and ultimately improve participant satisfaction. We also offer users the chance to take part in patient and public involvement(PPI) opportunities to shape how research is carried out and discuss any barriers underserved groups may face within a particular study. This feature was particularly popular when demoing the platform with under-served groups. We also incentivise learning, participation and completion through rewards and recognition, motivating participants and enhancing recruitment and retention rates.

Our trial team platform integrates robust data integration and visualisation tools to provide researchers with valuable insights into recruitment and retention statistics. TrialeX offers comprehensive demographic visibility for clinical trial teams, empowering them to dynamically adjust strategies to ensure improved diversity and representation. By leveraging this data, researchers can optimise their strategies in real-time, ensuring the effectiveness and inclusivity of clinical trials. Additionally, our AI-powered algorithm predicts and mitigates drop-out risks by analysing user data, enabling proactive measures to maintain participant engagement. It also offers suggestions to navigate interactions with under-served groups, such as addressing cultural barriers to participation.

Through these innovative features, TrialeX seeks to redefine the clinical trial landscape, through setting new standards for education, communication, data-driven insights and collaboration building trust within communities and driving advancements in recruitment, retention, diversity, ultimately propelling medical research and treatment forward. By introducing novel features and strategies, TrialeX aims to set new standards for how clinical trials are conducted and how participants are engaged. Particularly, TrialeX's focus on improving diversity and representation within clinical trials could have far-reaching implications for the healthcare industry. By demonstrating the value of diverse participant populations and the effectiveness of targeted retention strategies, TrialeX may encourage other organisations to prioritise diversity and inclusion in their own research efforts, leading to more equitable healthcare outcomes for all.

By prioritising education and awareness, we expect to see immediate outputs such as increased public understanding of clinical trials and their importance. Through our user-friendly educational content and personalised recommendations, individuals will gain knowledge about the purpose, procedures, and potential benefits of participating in clinical trials. This heightened awareness will lead to greater engagement with clinical trial opportunities and a more informed decision-making process among potential participants.

The provision of an in-app chat system and trial review capability will foster direct communication and feedback between researchers and participants. This engagement will enhance transparency, trust, and collaboration within the research community. As participants feel more connected and valued, we anticipate increased satisfaction, retention, and willingness to participate in future trials. This will result in higher-quality data and more successful trial outcomes.

Our incentivisation strategy, coupled with data-driven insights and predictive analytics, will lead to improved recruitment and retention rates. By offering rewards, recognition, and personalised support, we will motivate participants to remain engaged throughout the trial process. Our AI-powered algorithm will predict and mitigate drop-out risks, enabling proactive measures to maintain participant engagement and ensure trial completion. This will result in more diverse and representative participant populations, leading to more robust, generalisable research findings, and increased health equity for under-served populations.

In the longer term, we expect these immediate outputs to translate into broader outcomes for our target populations. By increasing public participation in clinical trials and improving the diversity and inclusivity of trial populations, TrialeX will contribute to the development of more effective and equitable healthcare interventions. This will lead to improved health outcomes, reduced healthcare disparities, and ultimately, better quality of life for individuals worldwide. Additionally, more time- and money-efficient clinical trials will result in higher turnover rates for treatment turn-over, enabling more life-saving treatments to reach those who need them. 

Overall, TrialeX's theory of change is grounded in the belief that informed, engaged, and empowered participants are essential for the outcomes of clinical trials to be successful and applicable to everyone. 

Long-term impact goals:

• Health Equity: Improve the demographic diversity of participants enrolled in trials facilitated through TrialeX, aiming for increased representation of under-served communities.

• Improved Research Infrastructure: Increase key performance indicators such as enrollment rates, dropout rates, and trial completion rates, demonstrating improvements compared to industry benchmarks.

• Increased Availability of Effective Treatments: Increase the number of new treatments that successfully complete trials facilitated through TrialeX and are brought to market, with a focus on efficacy across diverse demographic groups.

• Public Awareness and Education: Monitor website traffic, social media engagement, and participant feedback on educational resources provided through TrialeX, aiming to reach and educate a broader audience over time.

• Reduced Mistrust and Increased Transparency: Assess trust and transparency perceptions before and after engaging with the TrialeX platform through participant surveys, focus groups, and qualitative assessments, with the aim to build trust towards the healthcare system and clinical trials within communities over time.

• Faster Recruitment: Reduce the time taken to recruit participants for trials facilitated through TrialeX compared to traditional methods.

• Good Participant Retention: Reduce dropout rates and improve trial experiences monitored through participant feedback on their trial experience.

• Research Outputs: Set a new standard for the publication of research findings that incorporates demographic analyses enabled by TrialeX, contributing to advancements in medical research.

• Advancement Towards Personalised Medicine: Shift towards personalised trial outcome measurements by analysing trial data to identify patterns of treatment response among different populations.

Short-term impact goals:

• User engagement: Enroll 5000 active users on the TrialeX platform engaging with educational and trial-related content in the next 3 years.

• Enhanced Diversity in Trial Participation: Increase the representation of under-served communities in clinical trial participation by 20% within the next 3 years, measured by demographic data collected from trial participants.

• Reduction in Recruitment Timelines: Reduce the average recruitment timeline for clinical trials facilitated through TrialeX by 20% within the next 3 years, improving efficiency and accelerating the pace of medical research.

• Improvement in Participant Retention: Achieve a 15% decrease in dropout rates among trial participants using TrialeX within the next 3 years.

• Positive User Feedback: Achieve a minimum satisfaction rating of 4 out of 5 stars from users on the TrialeX platform within the next 2 years, demonstrating high levels of user satisfaction and engagement.

Community Outreach and Education: Conduct educational workshops or outreach events in at least 3 under-served communities within the next year to raise awareness about clinical trials and promote health equity, measured by attendance and participant feedback.

TrialeX harnesses a combination of modern technology, including mobile and web applications, as well as advanced AI and machine learning algorithms, to power our solution.

At the core of our technology stack is our user platform, which takes the form of a mobile application. This app serves as the primary interface for individuals seeking information about clinical trials, allowing them to easily access educational resources, browse available trials, and engage with researchers. 

Complementing our user platform is our customer platform, which is accessible via a web application. This platform caters to clinical trial teams and research institutions, providing them with tools and insights to streamline recruitment, retention, and management processes. From trial design and participant outreach to data analysis and reporting, our customer platform offers comprehensive solutions to enhance the efficiency and effectiveness of clinical trials.

Our technology relies on sophisticated back-end AI and machine learning algorithms to deliver personalised experiences and optimise trial outcomes. These algorithms analyse user data, such as demographics, preferences, and engagement patterns, to generate tailored recommendations for both trial participants and research teams. By leveraging AI-driven insights, we can screen participants, anticipate participant behaviour, identify potential recruitment challenges, and suggest strategies for improving trial engagement and retention.

All co-founders (total: 4) and on-boarded staff (total:1) are currently part-time whilst completing our studies. We are also working with 4 contractors to aid with development of the platform.

1.5 years: TrialeX was incorporated in October 2022.

Diversity, equity and inclusion is at the heart of TrialeX, and our commitment to ensuring DE&I is evident in everything we do. 

TrialeX is committed to fostering a diverse, equitable, and inclusive team environment, reflective of the communities we serve. Our team comprises individuals from diverse backgrounds, including clinical scientists, data scientists, designers, backend developers, and security infrastructure experts. We prioritise diversity and inclusivity in our hiring practices and team composition, recognising the value of different perspectives and experiences in driving innovation and addressing complex challenges.

Currently, 89% of our team members are people of colour, and we maintain a gender-balanced team with a ratio of 50:50 between male and female members. Additionally, three out of our four co-founders are female, demonstrating our commitment to gender diversity and women's leadership in STEM fields. We also prioritise open communication and feedback loops within our team and hold 2 team meetings every week, providing opportunities for all members to share their perspectives and contribute to decision-making processes. 

Additionally, we have spent over 200 hours speaking with customers and users including members of under-served groups to gather feedback and perceptions which have been implemented into our solution, ensuring TrialeX has been built with diversity, equity and inclusion at its heart.