COVID-19 has forced most of the world to work remotely, causing a major disruption in clinical trial research and the drug development process. As a result, the need for centralized and advanced patient engagement technology to better healthcare for all parties involved, including patients, doctors, researchers, pharmaceutical companies, and CRO’s, is now more important than ever before. The increasing need for globalized, shared research in order to better understand rare diseases and at-risk populations for genetic predispositions, as well as pandemic situations like COVID-19, makes accurate translation that is sensitive to local culture and customs of patient documentation and data critical for advancing healthcare globally.
The clinical trial process is notoriously a slow and costly effort; between patient data collection and security, to regulatory compliance, to ensuring safety and efficacy of treatments, it typically takes a drug about 7 years to go through all the phases of drug development. While the process is usually expensive and time consuming, it also often times leaves out the most important voice: patients. Patients have the most stake in clinical trials, however more often than not they are not accurately represented throughout the R&D process. Patient centric research is extremely important, not just in representing the patient better, but also in understanding the full efficacy of the treatment or drug therapy. Issues in unrepresentative data can lead to lack of diverse research, negatively impact patient engagement, and even lead to potential issues of the efficacy of the drug, losing life science businesses even more money and time. Accurate, reliable data that is reflective of the reality of the patient’s health and overall voice, while supporting accessibility to patient data for researchers globally, is important in both expediting the research process as well as ensuring the efficacy of the drug.
There are some organizations, however, that are working to resolve the issue. #HumanBehindEveryNumber is an initiative launched in 2017 by KCR, a CRO, that aims to better patient advocacy and engagement through targeted research in the clinical trial in order to improve the entire R&D process. The philosophy is simple: through understanding the patient and their perspective on the treatment, the disconnect between pharmaceutical companies, CROs, doctors, and patients will close as a commonality in creating a better designed clinical trial with the patients’ best interests in mind takes precedence. #HumanBehindEveryNumber is leading the initiative in facilitating patient’s voices to be heard from the very beginning of the clinical trial, ensuring the patient’s perspective is put first, engaging and reaching larger patient populations that were previously unheard. There is, however, still some disconnect in the late stages of clinical trials in sharing patient data to researchers, CROs, and pharmaceutical companies.
Patient data sharing is a tricky process; ensuring that their health information is protected, while also complying with local regulatory laws causes issues in terms of time and cost. Accessibility of patient data that is formatted correctly for regulatory compliance, while ensuring their protection, is an ongoing problem faced by doctors and researchers around the world. Castor EDC, an affordable and intuitive database and capture tool, is working to change this, however. Castor EDC is a platform that works to maintain security and quality so it may be reused again through their electronic data capture (EDC), eCRF, ePRO, and eTMF to accelerate studies in a safe and efficient way through AI technology.
The potential of sharing patient data is monumental; with proper adaptation of patient data, not only are patient voices heard and clinical trials improved, similar to projects like the one KCR launched, but they also help innovate and inspire more inclusive research in trials to come, simultaneously also better preparing countries all over the world for potential health disasters like a pandemic. Castor EDC has also been at the forefront for COVID-19 data research, providing their EDC free for researchers all around the world to help expedite the vaccine and drug development process, including both traditional as well as decentralized clinical trials. As the world is shifting to become more remote, the importance of staying interconnected through these technologically advanced trials conveys the importance of a centralized database for the R&D process. Beyond patient data sharing, the importance of the adaptability of the information to diverse cultures, including the availability of the data in multiple languages, so that doctors and researchers around the world are able to access and understand it in relation to their own research and patient care with scientific precision, is critical for true success of the application and others like it.
As the world becomes increasingly more global and connected, advancing patient engagement through innovative ways of intaking patient data, while of course still protecting it, so it may become reusable and utilized accurately is critical in improving patients’ lives globally. CSOFT Health Sciences provides expert medical communication solutions to facilitate global market access and success with patient centricity at the forefront, moving towards a healthier, inclusive future for patients of diverse backgrounds.
About CSOFT Health Sciences
CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.