Adding values to clinical trials: decentralized clinical trials and tech enabled clinical operations

Author: MW & Biometrics team – Genpro

It’s not important how many pieces you have, but how you connect them that leads to the result.

Had anybody ever thought about maximal use of electronic means for clinical trial operations before a few years? Certainly not, isn’t it! However, decentralized clinical trials (DCT) has been the key domain after devastating impact of the CoVID-19 pandemic. Not only from theoretical aspects, but the recent pandemic has disrupted the entire clinical trial operations ecosystem, leading to a remarkable upsurge in terms of innovation and research studies using DCT concept. (1) Let’s try to understand it bit more.

Unlike the conventional CT model with centralized data operations and governance systems, DCT introduces flexibility into the picture. Obviously, thereby the key components for any DCT framework would include electronic means such as telemedicine, wearable medical devices, patient-driven virtual health care interfaces, and many more. (2) As this framework of virtual execution incorporating technology can speed up the process and given restrictions within the purview of the new normal, it can be a boon provided that methodological rigor and integrity are ensured – which of course is a big challenge! To ensure this, hybrid model with- the system with combination of virtual and on-site methods for clinical trial operations is a hot topic nowadays. (3,4) This demands implementation strategies tailored to sponsor’s specific business needs. Also, regulatory guidance from FDA released in December 2021 promoted use of digital health technologies for remote data acquisition during clinical investigations amongst industry players, resulting in an increasing need for a consultation about the “fit-for-purpose”ness of digital health technology, technology description for DCT for regulatory submission, evaluation of clinical endpoints, statistical analysis, and data privacy and governance issues. (5)

Right from initial stages of protocol development to post marketing surveillance, effective implementation of hybrid trial model (HTM) may include but is not limited to conceptualization including trial design and supply and logistics implementation, patient recruitment, patient engagement, patient safety, end to end data management, study analysis and medical writing services. With cross-functional team experience and expertise, we can help you to simplify your clinical trials with digitally enabled platforms leading to fewer errors and shorter timelines and we can guide you with tech savvy clinical data monitoring solutions.

Our well-equipped data management center coupled with dynamic data scientists can add best value to your important DCT data comprising of supervising data collection, data handling, data transformations and data security in possibly accurate and protective way. Considering the data being spanned across multiple sites, validation or planning of the upcoming aspects from a data Monitoring perspective is highly important. Our team of data analysts are conversant with both conventional and modern adaptive cloud-based databasearchitecture and can provide insightful information visually in predicting the subject enrollment and other related factors to data monitoring.

Another important aspect that plays a crucial role in the success of DCT is medical writing services. Powered by insightful analysis and creative data visualization, medical writers along with biostatisticians from team Genpro culminate DCT communication in regulatory – compliant and patient-centric manner. Inspired by futuristic insights from prior experience on core patient journey mapping projects, our writers may also help you envisage the risk possibilities from clinical and privacy aspects and delineate effective full-proof risk management plan for your DCT with apt understanding of crucial pain points. Collectively, we aim to optimize DCT protocol and improve the patient experience by offsetting the participation burden of trial subjects and ensuring adaptive patient journeys throughout DCT.

Our premium product offerings exclusive for DCT may range from smart data capture, monitoring dashboards, data visualization platforms to entire DCT suite. These turnkey solutions are compatible with both “on premise” and “Software as a Service (SaaS)” deployment modes. We, team Genpro Research, are proud partners with Cambridge health to ensure seamless DCT solutions delivery to our clients.

As we move forward to adopt the new normal from the corona pandemic, it is the need of the hour to embrace the technology in our day-to-day clinical trial operations to improve patient experiences and patient outcomes. A well-planned and meticulously executed DCT will serve both purposes. Despite such advantages, optimum implementation of DCT concept in oncology is yet to be seen, indicating an existing know-do gap. (6) We are committed to improve patient lives with emerging innovations and scientific domain knowledge with an inclusive approach and look forward to bringing paradigm shift from conventional, tedious clinical trial data management practices and medical writing solutions.

References:

1 Anderson M. How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis. Bioanalysis. 2021 Aug;13(15):1195–203.
 
2 Van Norman GA. Decentralized Clinical Trials. JACC Basic Transl Sci. 2021 Apr;6(4):384–7.
 
3 Dorsey ER, Kluger B, Lipset CH. The New Normal in Clinical Trials: Decentralized Studies. Ann Neurol. 2020 Nov;88(5):863–6.
 
4 Rupp RE, Hawkins BE. Clinical Evaluation of Vaccines. In: Milligan GN, Barrett ADT, editors. Vaccinology [Internet]. Oxford, UK: John Wiley & Sons, Ltd; 2014 [cited 2022 Apr 9]. p. 260–72. Available from: https://onlinelibrary.wiley.com/doi/10.1002/9781118638033.ch15
 
5 Research C for DE and. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations [Internet]. U.S. Food and Drug Administration. FDA; 2022 [cited 2022 May 17]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations
 
6 Commissioner O of the. Advancing Oncology Decentralized Trials. FDA [Internet]. 2022 Feb 18 [cited 2022 May 17]; Available from: https://www.fda.gov/about-fda/oncology-center-excellence/advancing-oncology-decentralized-trials

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