The Future of Clinical Trials: Three Areas that Offer Big Opportunity for Change

By Christine Senn, PhD, as Senior Vice President, Site-Sponsor Innovation

As someone who has spent nearly two decades managing clinical trial sites, I’ve seen our industry undergo significant changes during my career. Even with new processes and technologies adopted, many practices remain inefficient, time-consuming, and stuck in a pre-digital world. Looking back on the past 10 years, I see three key areas that are pain points but also offer huge potential for improvement. These include the contract and budget process, the digitization of records, and patient recruitment. These areas have not only evolved but continue to shape the landscape of clinical trials. Here is a breakdown of some of what’s wrong with each area and how we can change them. 

Number One: Streamlining the Contract and Budget Process

The contract and budget process has long been a bottleneck in clinical trials. It has never been uncommon for these negotiations to drag on for multiple months, delaying trial start times and frustrating all parties involved. Even today, a typical academic medical center might take up to nine months to finalize a contract, whereas community sites, driven by financial needs, average around 45 to 60 days. The reality is that most of the key negotiations could be handled in a few hours if all sides focused on important points of contention. 

The industry has recognized this inefficiency and is beginning to adopt more streamlined approaches. The introduction of standardized contracts via preferred partnerships between sponsors, CROs, and sites have helped. Yet, it is still the case that silos within sponsor companies mean there need to be multiple master contracts for any preferred site involved in multiple therapeutic areas. The fact is, inefficiencies in any companies’ operations equate to delayed startup timelines, be it siloed therapeutic areas within a sponsor company, master agreements for a site not shared between a sponsor and its CRO, or inadequate training about how to process through multiple negotiations with the least amount of time wasted. 

The use of artificial intelligence (AI) to expedite reviews is a promising opportunity. AI, for instance, can help identify and correct inconsistencies in contracts and in budgeted procedures, reducing the time spent on back-and-forth negotiations. In fact, AI agents could probably handle 90 percent of the negotiations someday, leaving the key differences to be sorted out by humans. 

Number Two: Embracing Digitization While Battling Data Silos

Digitization has revolutionized how clinical trial data is handled. Ten years ago, paper records were the norm, and it made sense that data entry into a computerized system needed to be done manually. Today, electronic health records (EHRs), electronic source documents (eSource), electronic patient-reported outcome (ePRO) devices, and electronic data capture (EDC) systems are widespread. 

We know it should not be the case that data should have to be entered electronically twice; if it exists in one system, it should be able to be pulled into another system with the click of a few buttons. However, in reality, even systems supplied by the same vendor often require manual data transfers that are error-prone and time-consuming. Some companies are working on programs to help with data sharing, but widespread implementation remains a goal rather than a reality.

During the pandemic, remote monitoring and decentralized trials became more common, yet the infrastructure to support these models is still a work in progress. As we continue to refine these technologies, the focus should be on creating seamless, integrated systems that reduce the administrative burden on clinical sites. No one company can do this alone. As an industry, we need to come together and collaborate to streamline workflows and the exchange of data for the benefit of the sites that are the front line for patients. 

Number Three: Revolutionizing Patient Recruitment

Patient recruitment has always been and remains a critical challenge for clinical trials. Historically, recruitment efforts were fragmented and inefficient, contributing to delays and increased costs. Approximately 80 percent of trials fail to meet their initial enrollment targets, costing the industry millions in lost revenue daily.

I've personally seen the frustration that comes with outdated recruitment materials and processes. Many guidelines are antiquated, failing to resonate with today's patients, and sponsor-created advertising materials often arrive too late or in a format that sites cannot use effectively. Updating internal processes and leveraging modern marketing techniques are essential for improving recruitment outcomes.

Advarra is working on developing tools to help optimize patient recruitment by consolidating various recruitment channels into a single, real-time platform. Few sites have seen the benefit of patient recruitment tools in practice, but a solution that connects the sponsor, IRB, and site may fix that. This innovation could not only improve visibility into recruitment progress but also allow for faster course corrections when issues arise. Our research has shown that sites using centralized recruitment resources are 27 percent more likely to hit their targets.

Looking Ahead

Clinical trials are a vital part of the healthcare industry, yet the processes and technologies that sites, sponsors and CROs use to negotiate, manage and recruit for them need to improve. We are seeing some significant changes and widespread transformation on the horizon, though. 

By continuing to streamline contract and budget strategies, enhancing data system interoperability, and improving patient recruitment processes, we can overcome many of the longstanding challenges the industry faces. As we move forward, it’s crucial that we collaborate as an industry and work towards a more efficient, patient-centric approach to clinical trials.

For more insights and updates on clinical trial management, stay connected with Advarra and explore our resources designed to optimize trial operations and patient engagement.