The Changing Clinical Trial Space

The role of technology in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the rate of failures that could happen. Meanwhile, though there is a visible trend going on in the supply of technology and regulation of innovative methods is easing, pharmaceutical companies have been slow to use some of the most innovative technologies. This is probably due to the ambiguity prevailing around this space and a highly fragmented supply market.

The huge clinical trial costs, coupled with a higher percentage of trial failures and an increase in patient-centric trials, have caused a surge in demand for technology adoption in this space. However, digital technology is transforming the drug development process. The rise of wearable and mobile technologies along with cloud technology, Artificial Intelligence and related platforms, now enable the collection of frequent data throughout the length of trials. These technologies have the potential to enable innovative trial designs, improve the patient experience while establishing novel end points in the clinical trials space.

These technologies enables businesses to collect large amounts of data. This enables them to track how to best address evaluating fit-for-purpose, ethical concerns, and regulatory approaches. Digital Technology in Clinical trials will bring together regulatory agencies, biotech, pharma, patients, and academia to the latest advances and forward-thinking approaches. This will enable clinical for implementing digital technology to improve the trial processes and their results.

Meanwhile, there’s a big push for wearable devices such as smart watches to make their way further into the clinical trial journey. Modern and advanced wearable devices are capable of monitoring heart rate and other body vital signs. These devices are also capable to improve the clinical trial experience for patients by making it easier to take part. A patient using a wearable to track elements of their health doesn’t need to manually track this information. Wearables are more convenient and less intrusive for participants, since participants can contribute their data from the comfort of their homes.

Meanwhile, wearable devices help researchers by providing real-time data, unlike the typical trail experience. Here, researchers get looks into very small windows of a patient’s life, chiefly when they’re at a site, or rely on self-reports in between visits. As these devices enables real-time data collection thus reducing the time research staffs spend on data entry and increases their time on the science itself. The breadth of data that wearables provide to researchers allows for more accurate analysis and stronger data. This is especially true since there is a potential for a larger sample size.

The clinical research industry has pivoted toward decentralized and virtual trials due to the circumstances of the ongoing Covid-19 pandemic. With so many trials delayed, virtual trials have been one of the only ways to complete ongoing studies on time. There are also many benefits to these types of siteless trials. As a result, not having to travel to a site lifts the massive burden that many patients face, and eConsent technology makes it much easier for patients to opt-in. Technology is making it possible to connect with the world in ways that we might not have imagined a few decades ago. Siteless trials minimize health risks for patients taking part, many of whom have conditions that make them especially vulnerable to the disease.

Remote trial operation involves a steep learning curve for both patients and researchers. Study teams need to be trained on telework, network access including electronic health records (EHRs), and patient privacy. Research participants need to have access to any technologies required for the trial (internet and smartphones, for example), and they need to be savvy enough to use these technologies as the trial protocol dictates.

There are other challenges to virtual trials as well. Making sure investigational treatments sent to patients are properly controlled, used, and stored is a major concern. The need for lab testing to determine eligibility or monitor patients is an issue as well for virtual trials. When siteless trials require labs, recruitment companies can help facilitate this logistical part of the journey. Another important concern is data security. With more information stored in the cloud, researchers will need to ensure that patient data is entirely secure and unable to be hacked.

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