Clinical Researcher—February 2024 (Volume 38, Issue 1)

PRESCRIPTIONS FOR BUSINESS

Mark Melton, MSc

 

 

 

Precision medicine has emerged as a game-changer, revolutionizing the landscape of clinical trials and offering new hope for advancement of critical medicines. However, the intricate nature of precision medicine requires precision-based solutions for trial sponsors, clinical research organizations (CROs), labs, and research sites. The existing clinical trial management approaches no longer suffice, as they fail to serve the best interests of all stakeholders involved as the complexity of trials increases. Manual processes within the trial system often lead to operational challenges that also create data silos which cause mistakes carrying hefty consequences for patients, including the denial of entry into potentially life-saving trials when protocols are not followed. A lack of focus on effective communications and global data compliance can also prove to be costly in the long run.

To address these pressing issues, trial sponsors and research sites must pivot toward precision-based solutions. This transformation involves leaning into automation; prioritizing effective communication between sponsors, sites, and all vendors; and ensuring biospecimen protocol adherence. Having a game plan in place for global data compliance and implementing these strategies will surely promise substantial, long-term benefits.

Harness the Power of Automation

Leveraging technology is paramount for streamlining and automating processes, and for improving the traceability of lab kits, patient samples, and the data that result from testing those samples. Traditional manual processes no longer work for the complexity of precision medicine. These targeted clinical trials designs increase complex collections, biomarker assay designs, number of lab vendors utilized, and ultimately more complex data. It’s time to lean into automation to not only expedite trial progress, but also to safeguard the integrity of collected data.

One of the biggest problems I see right now is that the data that facilitate patient sample tracking and reconciliation come from many different sources, including trial sites, central labs, and third-party testing labs. These data sources have different databases, reporting capabilities, and business objectives. Sponsors, or their CROs, are often left to find ways to integrate, harmonize, and report out data from multiple systems. It’s a no-brainer that technology should be able to automate this process, and the best way to do so is to control both data input and output. This means controlling sample collections and data generated at the birth of a sample, and how those data are transmitted to lab vendors and reported out to ensure proper data integrity and sample processing. But the reality is that current technological solutions are fragmented, with some solutions managing input of data and others managing output. True automation should manage the entirety of the process from start to finish.

The potential impact that manual processes can have on patient care can be seen in the collection of samples for companion diagnostic (CDx) testing. These samples can gate the ability for a patient to be eligible for a trial, as they are used to show the existence of a specific biomarker a drug used on the trial is targeting. I was once part of a team that was running more than 40 trials, many of which involved CDx testing. There were thousands of patients being enrolled per month and tens of thousands of samples being collected across the globe. We were trying to manage all of this manually and had a big team to do the work, but the inability to get insights from clinical trial sites around these CDx sample collections, combined with delayed lab reporting, ended up causing several patients to screen fail. That means they couldn’t get potentially life-extending or life-saving treatments. This isn’t as rare as you would hope, and serves as an example that should inspire everyone to leverage technology for the sake of patient care.

Prioritize Effective Communication

Effective communication serves as the linchpin of any trial, but especially for precision medicine–based clinical trials. Implementing strategies to cultivate improved collaboration between trial sponsors, CROs, lab vendors, and research sites is pivotal for enhancing the efficiency and success of clinical trials.

A significant challenge lies in the differing perspectives held by sites and sponsors, as well as the complex role of CROs. Sites often feel undervalued, unheard, and burdened with the weight of trial responsibilities, while sponsors see themselves as industry experts with limited visibility into innovative trends. Complicating matters is the common involvement of CROs, positioned in the middle and promoting their own solutions amid high staff turnover. In addition, at times communication to the sites from the CROs doesn’t align with what the sponsor had intended, causing further confusion. This dynamic impedes the efficient, unbiased communication that is in the best interest of the patients.

For the most effective communication strategy, we need a multi-pronged solution that acknowledges the diversity of valid opinions. Site networks and site management organizations can do their part by helping sites simplify and harmonize processes while advocating for better compensation. This, in turn, provides sponsors with increased predictability compared to working with independent sites. It also empowers sites to negotiate better contracts and influence decisions made in the sponsor and CRO sectors of the industry.

Sponsors, if possible, should exert more influence over site selection and engagement, ensuring that transparent processes are being implemented. When leveraging CROs, sponsors must ensure messaging aligns with their intentions and remains consistent across all sites. It is also critical to ensure fair and timely compensation for sites. This not only demonstrates acknowledgment and appreciation, but also equips sites with the necessary resources, promoting enhanced communication and, ultimately, better patient recruitment.

Finally, it is also essential to institute rigorous site surveillance and implement metrics to measure performance. This approach helps gauge what is effective, identifies areas that need improvement, and facilitates informed discussions with sites about their standing relative to others involved in trials.

Ensure Global Data Compliance

In the realm of precision medicine, adopting a global perspective is a must. Sponsors and CROs should prioritize cross-border adherence to regulations, as establishing a framework for worldwide data compliance is a critical necessity for the success of precision medicine initiatives.

Data regulations, much like laws and cultural customs, vary depending on geographic locations. For instance, within the European Union, the interpretation of the General Data Protection Regulation varies among member countries, adding complexity to compliance efforts. Additionally, variations exist among broader regulatory bodies such as the U.K.’s Medicines and Healthcare products Regulatory Agency, the U.S. Food and Drug Administration, and the European Medicines Agency. Diverse guidelines, laws, and recommendations can all go on to impact restrictions on sample collection, permitted tests, duration of sample and data retention, and geographical constraints on these activities. A failure to comply with these different guidelines could result in financial penalties and impediments to utilizing collected samples and data for testing and analysis.

There are two ways to address the challenges of running cross-border trials. First, maintaining rigorous control over informed consent forms (ICFs) and securing language approval are critical. The ICF delineates, among other things, permissible actions with samples and data. Second, engage legal and compliance experts in different regions to push back on divergent interpretations of the relevant regulations. This helps to ensure meticulous oversight of how data are processed, managed, stored, and ultimately disposed of, in compliance with regulatory requirements. Together, these measures establish a robust framework for navigating the intricacies of global data compliance in precision medicine clinical trials.

Conclusion

The paradigm shift toward precision medicine within clinical trials demands a strategic integration of precision-based solutions, including automation, effective communication strategies, and global data compliance. Automation is key to optimizing processes, ensuring data integrity, and protecting the interests of patients. Establishing transparent communication strategies is crucial for fostering optimal collaboration between trial sponsors and research sites. Finally, when trials cross borders, having a plan in place to ensure global data compliance becomes a must-have. Precision medicine demands precision-based solutions, and integrating these three key elements holds substantial long-term benefits for the advancement of critical medicines.

Mark Melton, MSc, is Vice President of Scientific Operations and Development for Slope.