At the dawn of the new decade, clinical trials experienced exponential progress due to the outbreak of COVID-19 and the advancements of technology.
Emerging technologies help pharmaceutical and clinical industries perform predictive, prescriptive, and diagnostic analytics. Rising star, Big Data, is one such example that informs both drug discoveries and developments.
TecEx Medical has observed industry interest in readily adopting new technologies and methods to overcome obstacles in the clinical trial life cycle. We have curated a list of top trends expected to impact trials in 2023.
Alternative trial designs gained increased popularity at the onset of the pandemic as national and global shutdowns forced organizations to seek different ways to conduct trials. Decentralized clinical trials were one such design that became a critical strategy, and even as the world returned to the “new normal,” sponsors continue to see this method as an effective means to collect data. With this trend comes a shift in supply chain processes that require a new set of expertise to maneuver the increased geographic scope of work and garner more diverse populations. TecEx Medical can facilitate the demanding compliance and import requirements for stakeholders in the trial space.
The FDA released a recent mandate calling for a “Race & Ethnicity Diversity Plan” for every study. This mandate requires sponsors, CROs, patient organizations, and site communities to change how they manage trial feasibility, design, and execution. Drug developers creating real-world diversity will be better positioned to serve patients and achieve regulatory compliance. To improve their studies, trial sponsors should look at approaching community and advocacy groups alongside CROs who expertly navigate the changing landscape and understand the importance of developing inclusive trial designs.
In addition to the FDA implementing real-world diversity mandates, the focus has shifted to real-world data (RWD) and real-world evidence (RWE) collection in trial design. This shift in data science enables developers to be adaptive and utilize RWD/RWE to their fullest potential. It is also paving the way for more complex, specific clinical trials to be initiated and further modifying current supply chain processes.
As data science and digitalization become increasingly prevalent in clinical development and cell and gene therapy trials dominate the landscape – organizations will benefit from partnerships with CROs with specialized expertise in these areas. The outsourcing of clinical trial activities has seen a reported increase over the last two years. Some leaders acknowledged being more likely to outsource some or all activities to a CRO.
Technology is only useful if you know how to use it and understand how it works. For this reason, online training for new technologies will continue to be a focal point in the pharmaceutical industry to improve operations and compliance. This training is a highly beneficial tool as it can be customized to suit the needs of each user, and it can be taken at any time from anywhere. Companies also ensure that teams use technologies such as patient schedule portals and electronic document software correctly, thus minimizing the risk of errors and contributing to compliance around the use of information.
Digital processes, in conjunction with digital training, will continue to help make operations more efficient, drive regulatory compliance, and allow pharmaceutical companies to track data accurately.
Forrester predicts remote patient monitoring (RPM) tools will play a critical role in treating multimorbid patients to mitigate potentially avoidable hospitalizations and the exacerbation of chronic diseases. The global RPM market is projected to reach $175.2 billion by 2027 from US$53.6 billion in 2022, at a compound annual growth rate of 26.7%. Devices like weight scales, pulse oximeters, blood glucose meters, blood pressure monitors, heart monitors, and wearables will improve clinical prognosis and remove socioeconomic hurdles due to social determinants of health.
Pharmaceutical companies will continue embracing technology to increase efficiency, ensure compliance, improve drug traceability, and simplify transactions. The focus will continue to shift to be more human-centric as research and development push for more precision medicine and remote patient monitoring. Trial designs are predicted to experience greater change as sponsors look to alternative, more inclusive designs that would ultimately represent the real-world diversity of the population. At TecEx Medical, we continuously monitor emerging trends impacting the pharmaceutical and clinical industry to improve our service offering to our clients and keep them informed.
Are you looking to import medical goods for your clinical trials but don’t know how to get through customs? TecEx Medical is a specialist Importer of Record (IOR) and can distribute clinical trial supplies across the globe. As the IOR, we take on all the responsibility, from taxes to documentation, and project manage the shipment, so your commodities arrive safely and on time.
Reduce your responsibility and avoid stuck shipments by reaching out to TecEx Medical today.