The clinical trials stage is the longest step in the drug development process. Its success rate is estimated to be between 10% and 20%, depending on the therapeutic areas being considered. AI and telemedicine are being incorporated into clinical trials and are enabling virtual trials that are significantly cheaper to operate than traditional ones. Additionally, the automation of workflow processes and regulatory documentation requirements are reducing the operational costs of running a clinical trial.
Technology has the potential to improve the success rates of clinical trials through data-driven feasibility studies and the crowdsourcing of clinical trial protocols, helping improve clinical trial designs and tackle the lack of commercial interest. As the pharmaceutical industry grapples with the pressure the drug development process puts on financial returns, clinical trial tech provides an avenue to expand returns by reducing the time and effort required to bring new drugs to market.
Startups in the growth-stage and providing clinical trial management solutions are most common, with several startups initially offering one specific solution before expanding into offering solutions across multiple parts of the clinical trial process.
Incumbents also focus on the clinical trial management segment in terms of partnerships and acquisitions, as these tend to have the most value in terms of improving the speed and cost of their own clinical trials.
Pharmaceutical companies and clinical research organizations are increasingly adopting clinical trial technology to expedite the drug development process. Given that clinical trials are the most time-consuming step in drug development, any reduction in the time necessary for them would be a huge benefit. Patient recruitment is one of the major bottlenecks in clinical trials, as per incumbents such as AstraZeneca.
Additionally, multiple tech companies have expressed interest and are working in the clinical trial tech space due to the significant volume of data that needs to be processed and the potential for providing cloud services and conducting Big Data analytics.
Recently, some incumbents have chosen to develop in-house solutions to address these issues, such as remote patient data collection to encourage trial participation and efficient clinical trial design. Other incumbents, however, prefer to work through partnerships with relevant startups, and, in some cases, with other incumbents that specialize in addressing challenges in the clinical trial process. Incumbent M&A activity in this space has been muted, with Oracle’s acquisition of clinical trial software provider goBalto in 2018 being the only notable deal.