ClinicalTrials.co featuring Trial Connect

With over 130,000 trials last year in the USA alone, and over 400,000 studies posted on clinicaltrials.gov, all with verbiage directed toward the clinical and medical community, the average patient has a nearly impossible time understanding the basics of clinical trials and discerning the nuances between different trials. Thus, millions of people decide not to pursue clinical trials as a means of treatment, a detriment to them and their health journey AND to pharmaceutical companies and CRO’s that need to fill trials in order for drugs to come to market.

Additionally, clinical trial recruitment is a massive expense for companies, costing an average of $7000 PER PATIENT recruitment for a study, while the average cost to replace a patient that dropped out of a study is $20,000. Quite frequently the cost can go as high as $250,000 to recruit a SINGLE patient for an oncology or rare disease trial, all the while patients are desperately looking for a lifesaving treatment and not being able to find the right trial. Projections suggest that recruitment costs will continue to rise over the next decade, placing a recruitment and financial burden on clinical trials.

Overall, the current landscape lacks a comprehensive source that connects patients with relevant clinical trials. Patients often struggle to access needed patient support, and timely updates on clinical trial news are scarce.

Our solution aims to address these problems by providing easily comprehensible trial information, connecting patients with appropriate trials, and offering support and clinical trial updates. Our solution begins with our “clinical trial guide (available at clinicaltrialguide.com), helping a patient from the moment of diagnosis with information and searchable content that allows patients to get information they need to understand the clinical trial process. From there patients are directed to “Trial Connect” which provides them with plain english information about the trials that are relevant to them. From there it connects patients directly with the pharmaceutical company, CRO, or trial site that is suitable for them. With excellent SEO work, our current site (MVP) ranks a head of the FDA on some of the most popular clinical trial search terms, allowing it to be easily found by patients at the point of diagnosis. 

Our solution is a Win-Win-Win for patients and caregivers, pharmaceutical companies, and CRO’s, and society as a whole. 

This solution provides patients and caregivers the opportunity to search and understand the clinical trial options available to them and register for a potentially life saving trial. 

Pharma companies and CRO’s can use this solution to increase the number of patients in their clinical trials. Additionally, pharma companies and CRO’s can market  specific clinical trials at important timeline junctures, and pre-qualify patients for other eligible trials. 

Last, our solution is a huge win for society because it fosters trial enrollment enabling drugs to come to market faster so that patients can receive treatments they so desperately need.

Our team is uniquely positioned to deliver this solution because of our diverse backgrounds and expertise. We have team members that have successfully built pharma companies and been in the pharma industry for over two decades. We have a fantastic web design and web development team. Our chairman is the CFO of a publicly traded company who understands the financial needs of such a company and we have an SEO expert who has brought our site atop of the FDA on google search terms for certain clinical trials searches. In addition, we have medical writers that have produced patient centric information for consumption and we have company advisors to help us grow and strengthen each part of the business.

Most importantly though, our leadership team arose and joined together because of people they were close with who struggled to find a clinical trial that would give lifesaving treatment to close family and friends. It was from these relationships and health journeys that our founders understood the need for such a solution. 

Our solution is innovative because the most current information resource that patients go to to get clinical trial information is clinicaltrials.gov This is a government website, part of the regulatory process in the USA, that requires pharma companies to post every trial they are conducting for regulatory purposes. Most of this information is industry focused and impossible for the average patient or caregiver to understand. Our solution addresses this and puts basic clinical trial information in the hands of the patients.

(We had planned to provide an example of how challenging clinicaltrials.gov can be for a patient to understand but we cannot provide it because of the word count, so please reference the following links for examples:

https://classic.clinicaltrials.gov/ct2/results?cond=Heart+Diseases&term=&cntry=&state=&city=&dist=

https://classic.clinicaltrials.gov/ct2/show/NCT03891160?cond=Heart+Diseases&draw=2&rank=1

Our solution will be the first to enable patients to get the information about clinical trials that they need for themselves, without having to rely on unreliable sources or external sources for information that they cannot understand. This is largely change the market because it will give power to patients to take control over their health journey through clinical trials, ultimately increasing enrollment and recruitment of patients in trials and ensuring that so many more patients receive life changing treatments. 

Our solution directly addresses the UN Sustainable Development Goal 3 by enabling and promoting new solutions for health to address patients that are desperately looking for life saving treatments. For example, one of the goals set forth is access to healthcare. Our solution will give untold millions of people greater access to healthcare options that they would otherwise never have been able to consider or access through clinical trials. Another example is the goal of reducing maternal mortality and child mortality. Both of these goals will be enabled through giving mothers and children access to clinical trials for lifesaving treatment that they would have never been able to access on their own. 

The AI-driven solution is powered by a blend of sophisticated technologies and diverse data sources. At its core, the OpenAI GPT Series API plays a pivotal role, leveraging advanced natural language processing capabilities to interpret and simplify complex clinical trial information. This is integrated seamlessly with a Kubernetes infrastructure, which manages and scales data engineering pipelines efficiently. The system’s backbone is formed by Django, a high-level Python web framework, known for its rapid development and pragmatic design, alongside a MySQL database for robust and secure data management. This intricate integration ensures that each component works in harmony to provide a responsive and user-centric platform.

Underpinning the AI's capabilities is a rich tapestry of data. Domain expert labelers provide high-quality, accurately labeled data, essential for training the AI with contextually relevant and precise information. User feedback serves as a critical component, guiding continuous refinement of the algorithm to better meet user needs. Data generated from user interactions, such as site traffic and trial registrations, offer valuable insights into user behaviors and preferences, further tailoring the AI's recommendations. Additionally, information from pharmaceutical companies, including detailed trial data, is crucial for the AI to effectively match patients with appropriate clinical trials. Together, these data sources not only fuel the AI’s learning process but also ensure the solution remains dynamic, secure, and aligned with user privacy and healthcare data security standards.

We prioritize user privacy and data security. This involves implementing robust encryption regarding user data and adhering to HIPAA guidelines (or similar regulations in other countries), and ensuring that data sharing complies with privacy laws. Regular security audits and risk assessments would help identify and address vulnerabilities. Users and entities using the platform would also be clearly informed on how their data is being used. The platform should clearly explain the AI's role and limitations in simplifying clinical trial information and matching patients to trials.

AI models can inadvertently perpetuate biases present in their training data. It's important to ensure that the AI does not favor certain demographics over others in trial recommendations. This can be addressed by diversifying the data used for training AI models and regularly testing for bias.

There will also be ethical guidelines in place for AI usage, including considerations for patient autonomy and avoiding undue influence in clinical trial choices. 

Our impact goal for the next year will be to ensure that clinical trials can be posted on our trial connect platform, available to patients, and used by patients to make better and educated decisions about clinical trials as a treatment option. Our five year impact goal will be to ensure that several key studies in oncology are recruiting faster and helping patients get life saving treatments that they need. In addition, we aim to have at least 50% of all ongoing trials in the USA on our site within five years. With faster trials, we can help meaningfully bring about a faster drug approval process bringing approved drugs to market and more importantly a greater number of patients.

1 full time

6 part time

2 years

We have people from diverse backgrounds, genders, and ethnicities all working together to create a solution that will help people from diverse backgrounds. In addition, one of the largest struggles in the recruitment process for clinical trials is that pharmaceutical companies need to reach a broader and more diverse audience of patients and are struggling with how to find those patients. Our solution will enable millions of patients with diverse backgrounds to find the right trials for themselves and thus increase diversity, equity, and inclusion in trials.

Our operational plan includes team members with various strengths and responsibilities that will allow our site to be the number one most visit site for clinical trial information. To begin, we have teammates who are SEO experts to ensure that we remain at the top of google searches for the most popular clinical trial search terms (as we are now ahead of the FDA on some of the most popular search terms). By drawing patients to the site as much as possible we become even more popular to pharmaceutical companies who want to reach the most patients.

In addition, we plan to implement a lot more social media content and advertising to draw both patients and pharmaceutical companies to the site.

We also have team members working on PR and we are always increasing the content and articles we have on our site so they are up to date and as relevant as possible.

We also have key partnerships and relationships at some of the countries largest pharmaceutical companies and CRO's so that as soon as our product is ready to launch they already know what we are doing and are eager to be a part of the solution. 

Last, we are truly a team of growth-oriented people who want to grow and learn and be flexible to find the right solution for the most people. 

Our plan to become financially sustainable includes working with pharmaceutical companies to drive enrollment to their studies. Pharmaceutical companies and CRO’s currently spend hundreds of  millions of dollars every year on recruitment costs and those costs are only predicted to rise. We understand that by partnering with us pharmaceutical companies will be able to cut other recruitment costs because their studies will be more accessible to patients. This in turn will lead to increased revenue for us as a greater number of  studies are posted on our site. 

Our current operating costs are around $75,000 yearly. With the expansion of our company and the costs of development, our projected operating costs for the next year will be just under half a million dollars. This cost will break down into three main categories Marketing, Web Development, and G&A. Within those categories we have budgeted for SEO, PR, Social Media, PR, Operations, Sales, Legal and Admin, Content development, and web development. 

We are seeking $100,000 to fully develop the trial connect platform that will incorporate the appropriate AI components. The reason we have requested this amount is because with this number we will be able to launch as a functioning platform, enrolling studies, helping patients, and driving cures to the next stage of development. 

I think the mentorship and networking opportunities will be key to the success of our company with the Cure Residency program. This will allow us to connect with mentors who will help us take our company to the next level as well as the correct individuals in this space who are decision makers in clinical trial recruitment. In addition, this will give us access to companies that are currently running clinical trials and allow us to help them.