The clinical trial ecosystem, Real World Evidence (RWE), relying on Real World Data (RWD), has reframed traditional clinical trials. Today, “the FDA uses RWD and RWE to monitor post-market safety and adverse events and to make regulatory decisions. ” The fact is that Real World Evidence has yielded extraordinary insight. Metformin, a diabetes medication, is a prime example of RWE in action as a recent discovery found the drug can have a significant effect on cancer prevention. As a result, more than 300 clinical studies are now evaluating its effectiveness and its impact on various other cancers.
RWE also plays a pivotal role as we move towards more personalized medical treatments and precision medicine. RWE can expand the spectrum of data captured and can be used complementary to the traditional clinical trial model. RWE helps with alleviating the drawbacks of the well-known limitations of clinical research and allows data to be collected and generalizable over a real-world patient population. Today, we turn the focus to patient-centric technologies, and, with the help of ICON’s white paper, we take a look at a theoretical patient’s trial journey that explores how various technological solutions can improve the clinical trial process.
Technology solutions
From study design to closeout, the clinical trial model today is evolving to rely more heavily on technological solutions. It is, therefore, a daunting task for stakeholders and clinical trial sponsors to consider which solutions to select. The ideal solution must: handle massive amounts of data, be secure, regulate complaints, be auditable, and be accessible to different stakeholders at one time - not to mention, be cost-effective and user-friendly. This is an incredibly tall order, but the good news is that technological solutions are constantly evolving and the clinical trial ecosystem is prime and ready to take advantage of these innovative solutions.
The one platform solution and what to consider for integration
When thinking of technological solutions, using one large platform that provides an all-in-one experience is a great option for clinical trials; where one product provides an interface with multiple functional solutions and another solution that utilizes the best technology for each functional area. These platforms allow clinical studies to manage their big data sets effectively.
As clinical trial stakeholders look to roll out new patient recruitment and engagement methodologies, many are now realizing that, despite the exciting prospect of increased efficiency, the process of actually implementing these solutions can be quite cumbersome. The additional credentials and logins for different solutions, the site burden of implementing and training on the new technology, and other issues related to software implementation and integration, are some of the more obvious concerns.
The good news is that the tech industry is working diligently to provide new integration technologies to allow for these solutions to seamlessly integrate into existing clinical protocol. In addition, utilizing these independent technological solutions is also the most cost-effective option as there is no monopoly power which is found in the platform model.
Another essential to seamless integration of technology is the phase in which you integrate a solution. The general rule of thumb: the earlier, the better. If a tech solution is selected in the planning stages and a partner is chosen that is focused on providing the best experience for the user, whether that be the patient or multiple stakeholders within the clinical trial process, the more seamless the integration will be.
Citruslabs technology solution for your clinical trial
Citruslabs’ solution provides research sites with the heterogeneous pool of participants that are highly targeted on behavioral, medical, and demographic data and carefully matched to your clinical research. We have access to a wide patient pool that we properly, skillfully, and consistently educate on clinical trials. It is, therefore, no surprise that we continue to produce high rates of qualified patients, with high confidence records. Our patient recruitment dashboard is especially important in supporting RWD collection based on real-world scenarios.
Leveraging our years of experience in patient recruitment into our technological solution, we work tirelessly to help research sites and sponsors achieve their desired endpoints effectively and efficiently. Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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