It can take more than six months to launch a trial, according to figures from Advarra. What’s more, since COVID-19 landed on the planet, the pressure is on more than ever before to get clinical studies kicked off quickly.
Outsourcing-Pharma recently connected with Jonathan Shough, president of technology solutions with Advarra. He offered insights on the factors leading to increased interest in accelerated startups, and how metrics can help speed up the process.
OSP: Could you please talk about how the clinical research field has rapidly evolved in recent years, and the forces behind these advancements (COVID-19, as well as other factors)?
JS: In recent years, the clinical research field has evolved in several ways. Research and development have become more patient and site-centric. The pandemic has forced business leaders to completely rethink the ways in which they conduct clinical trials on a global scale.
During this period, we’ve realized how important different types of patients are to a clinical trial design and its associated outcomes. Researchers are identifying more inclusive and broader patient populations and are expanding access across the global population. Also, advancements in technology and the use of multivariate data contribute to more informed decisions around subjects and sites and provide meaningful insight into how treatments and therapies are performing.
Finally, an intensely developing computing environment globally, combined with a regulatory environment that’s increasingly focused on the use of real-world evidence (RWE) to assist in making approvals based on data, allows for the advancement of outcomes and regulatory approvals.
OSP: How have demands and expectations around expediting the timeline of a trial changed in recent years?
JS: Because of the pandemic, we are now in an era where the technologies that have been available for quite some time, as well as a regulatory environment that's more accommodating of those new technologies, are enabling expanded access to patients, increased patient control, and more inclusive protocol formations. Technologies and approaches that would have been groundbreaking just a few years ago, like data-driven RWE development, AI-driven clinical research, and operational approaches such as decentralized trials, and hybrid clinical development activities, are now commonplace.
The COVID vaccine development and ensuing rollout have showcased the astounding speed and efficacy of clinical trials at scale, and organizations have since realized that they can leverage decentralized technologies to encourage optimal trial candidates to participate. Decentralized clinical trials can make data collection, analysis, and submission processes faster.
The results are clear - we’ve swiftly delivered one fully FDA-approved COVID-19 vaccine in less than three years, and other treatments from multiple pharmaceutical corporations. These vaccine treatments were brought into the marketplace through hyper-data analysis and development testing.
OSP: What technology tools have sites and sponsors put to work that are intended to help shorten the time it takes to launch a trial?
JS: The continued advancement and expansion of wearable devices is having a substantial impact on our ability to improve relationships between patients, sites, and sponsors. This confluence of people, process, and technology can reduce the timeline of a trial in many ways.
Wearable devices harness data, reducing the manual labor required to clean data. They also improve subject data participation that’s passive. It might be too early to say citizen data managers are helping us manage data - but we’re not too far off from that.
There is a continued need to review results and ascertain if these “citizen data managers” will improve data quality and availability. The improvement and integration of technologies that sites use, along with the technology that pharma and CROs use, is improving data quality and reducing work that’s happening at sites - specifically sites with more than one customer or indication. That’s important because the sites can perform far better when they can use their own technologies as integrated services that support pharma/CRO systems.
When coordinating between sites and sponsors, parties sharing technologies allow for site training, patient training, and compliance against protocols. Sponsors and sites can work together using a “universal platform integration” approach that will provide seamless shared technology for better trial outcomes.
OSP: Then, could you please tell us a bit about the metrics-centric tools and data trials have increasingly leaned upon to help launch and run trials more efficiently?
JS: Trials have leaned on metric-centric tools to expedite the selection of sites and ensure that sites can deliver the best performance and fit for the patients and therapeutic focus. Tools also allow for increased confidentiality and study planning.
Clinical trial management systems with strong reporting capabilities enable visibility into key considerations like:
- Which studies are not meeting expected objectives and fail to achieve enrollment targets?
- Which studies are in the process of study start-up and how are they progressing towards activation compared to expectations?
- Am I getting a representative sampling of my recruitment area, by location, gender, race, and ethnic status, etc.?
- How much staff time (effort) is going into activating a new study?
- How has accrual within a specific management group performed over time?
Measuring performance yields clear benefits for sites: sites can gain enormous benefits in terms of improving internal operations and working with sponsors including:
- Identifying where process improvements can be made
- Identifying where resource allocations can be changed
- Effectively managing workloads across teams
- Establishing performance benchmarks
- Providing data-driven rationale to leadership for additional resources
Sponsor relationship benefits can also help identify areas of strong competitive advantage and can provide the ability to complete site feasibility questionnaires with real-time data.
OSP: Also, please tell us about how collaboration and sharing of data can help boost efficiency and effectiveness.
JS: As systems proliferate, more data is created - but that data can be siloed. Integrating systems and data ensures consistent visibility into data and supports improved collaboration. Access to common data improves coordination and execution of trials – especially in the growing decentralized clinical trials (DCT) world.
Collaboration allows sponsors and sites to have shared objectives, allowing for a more patient-centric trial that can deliver more effective therapies, faster. When there is collaboration between sites and sponsors, there’s a better chance that sites will be able to properly educate patients on the trial, address previous complaints, and comply with trial protocols – leading to better research overall.
OSP: If you could please gaze into your crystal ball, what might be ahead, in terms of new technologies, and expectations placed on clinical trials?
JS: In the next five to 10 years, trials will continue towards patient-centricity and as people grow more comfortable with new technologies, decentralized clinical trials will become the norm – not the exception. As the industry becomes more tech-savvy, patients will desire and expect optionality in clinical trials, and the industry will be expected to deliver treatments within shorter and shorter time frames. Because of these increased expectations, developers will begin to use devices like wearables more often to make data collection an easier and more accurate process.
OSP: Could you please share some of the ways in which Advarra is helping its clients deal with these formidable expectations?
JS: Even with tremendous technological advancements, trials are still becoming more and more complex. While our attention has been captured by the unfolding of the pandemic, there continues to be significant investments in other key therapeutic areas, like oncology and CNS-related diseases. Due to the nature of these areas of focus and their complexities, protocols and patient burdens continue to increase.
On top of that, researchers are being required to use six to seven applications per trial. At Advarra, we’re helping our clients at the site level to deal with this increasing complexity with solutions like eREG and OnCore, and at the sponsor level with CIRBI and Longboat. Advarra’s portfolio of technology solutions allows sites to gain comprehensive management of their research operations and enable strategic decision-making for even the most complicated trials.
In addition, the growing use of our technologies within pharmaceutical corporations and contract research organizations will continue to improve the overall development of therapies and vaccines that will, in turn, benefit patients across the world.
OSP: Anything to add?
JS: When the world returns to normal, many industries will discuss how they rose to the occasion despite the fear and uncertainty of the past few years. However, the stories about the patients, clinical trials, sites, and their combinatorial value in delivering vaccine candidates at great speed will be the most consequential.
While many industries were halted by indecision, the clinical trials industry maintained its commitment to improving global health while leveraging pioneering digital advancements to keep its most promising assets alive. The incredible success of the vaccine trials proves that the best is yet to come for the industry.