Five Areas That Will Define the Future of Clinical Trials

Henry McNamara

After two years of rapid change and transformation and technological adoption accelerated by the pandemic, pharmaceutical companies are now faced with more choices than ever before.

The industry has now become focused on cost-effective models that bring value. Today, there is not enough value in stitching together solo, siloed technology solutions. Instead, companies seek technology platforms that offer streamlined vendor engagement/management, configurability for scale and speed, and holistic analysis and insights. And these solutions must enable speed to market while keeping costs down.

Here are five key areas of innovation to watch as the life sciences industry looks to reach this pinnacle in 2023.

• The global economic situation will lead to a consolidation of tech vendors. Over the last decade, there has been a boom in the number of startups in the life sciences space. But that won’t be sustainable as funding starts to dry up given the overall state of the global economy. There will be less capital and what capital is available will be risk-adverse However, this trend will not affect the number of trials at scale.
• Expanded adoption of AI and Machine Learning will continue to transform the pharmacovigilance market. It’s critical that drug companies stay on top of new innovations/inventions as they come to market. As new treatments—such as the COVID-19 vaccines—come to market faster, patients and providers need to have accurate safety information and be informed of possible adverse reactions. A well-designed, automated system using the right technology can help eliminate tedious and repetitive tasks, reduce data entry errors, and even enable “predictive” signal detection.
• The retail pharmacy model in clinical trials will continue to grow. Recently CVS and Walgreens have instituted flexible clinical trial models that combine patient insights, technology capabilities, and in-person and virtual-care options to engage broader and more diverse communities. This type of collaboration will continue to grow and expand, resulting in more expansive participant pools and more accurate information about populations where drugs are effective and other populations where they might not be as effective.
• Real-world data will be critical in decision making. Emerging platforms—like EHR and connected devices—will enable companies to collect larger quantities of high-quality real-world evidence. The insights from this data, combined with clinical research data, will shape drug companies’ approach to all aspects of business including discovery, understanding safety in real-world conditions, go-to-market strategies, and how they run their clinical trials.
• Companies will pool data to try to get through regulators faster. As trial sponsors look for ways to gain regulatory approval faster, we will see companies that conduct trials in similar spaces pool their data to showcase a deeper set of results. Bringing together this type of large, cross-study data set will help demonstrate a wide variety of results to regulators, thereby potentially enabling a faster approval process. This pooling effort must be scientifically justified, prespecified, inferentially rigorous, and convincing to the medical community and regulators. An innovative biostatistical approach is needed for analysis of the pooled data.

The COVID-19 pandemic challenged status quo and served as a catalyst for the adoption of the technology-enabled ‘patient-centric’ decentralized clinical trials model. The reality of this shift to the new norm has led to most of the industry planning on continuing to implement newer clinical trial models and technologies. And with patient optionality ruling the day, organizations must plan on giving patients the choice about how they participate in clinical trials. The organizations that strike the balance of cutting-edge technology and patient centric models are the ones that will succeed in leading the industry this year.

Henry McNamara, SVP and GM, Oracle Health Sciences