Jim Murphy

Overall clinical trial operational excellence

The lingering impact of the COVID-19 pandemic has proved that we need to focus on adding new solutions and process improvements to ensure resiliency in clinical trials. However, it’s essential that we don’t think short term. In a new Greenphire survey, sponsors and CROs ranked “enhancing their clinical trial operational effectiveness and speed” as their most important area of strategic improvement for their organization.

To deliver better clinical trials, the industry needs to get better at the business side of medical discovery. Connecting the financial and administrative dots from budgeting through payment execution and the ongoing management of the study can streamline operations, create financial transparency and accelerate overall timelines without sacrificing quality.

 Sites are at the heart of any clinical trial and should be highly valued. In order to alleviate some of their burdens, sponsors have been more open than ever to investing in technology, especially as COVID-19 arrived.

These technology solutions can be a great benefit to sites, but they also have the potential to cause more burdens and stress. While technology is the future, in the coming years, as adoption increases, we also will see more consideration for the potential burnout it can bring for sites. We’ll see more technologies be integrated with each other and using single sign on (SSO) capabilities to improve the user experience.

 Previously it was thought that it was “enough” to purchase technology solutions for sites to use. This does not always result in a positive site experience and we will see in 2021 and beyond that more time and support is going to be offered to sites to ensure that they not only know how to start using new tech solutions, but to offer resources to turn to when there are questions and challenges.

 Cashflow in trials has always been vital to keep them on track. Now that studies have startup timelines that are half (or even less) of what they’ve previously been, we will see more sponsors supporting sites by ensuring they have enough funds to start and keep things moving smoothly.

Increase in digitization and the regulation that comes with

Sponsors are conducting trials in more countries than ever and all while adopting more and more technology. While this is positive progress, that expansion and technology adoption come with a host of global mandates and regulations which continue to evolve, making things more complex. From tax to data protection, which can vary from country to country, there will be more regulations to consider than ever before. We will see solution providers attempt to offset this by building in flexibility and compatibility into their technologies. 

COVID-19 took everyone from working in the office to home (if possible). This rang true for those participating in clinical studies as well. While some trials paused, others continued with an updated protocol to enable patient participation from home.

Not only did this pandemic prove that remote participation is a possibility, but that it might actually increase engagement and compliance. Sites and in-patient visits will not go away, but it’s clear that we are going to see an increase in both telemedicine and the use of electronic clinical outcome assessments (eCOA) and electronic patient-reported outcomes (ePRO), as a result.

COVID-19 sparked a race to a virus diagnostic, anti-body test and vaccine. This meant that trials, which in the past would have taken months (or years) to initiate, began in only weeks. While it’s not reasonable to think that these extremely accelerated timelines will stick as-is, processes will continue to be evaluated and improvements will be made. Shortened timelines will not be sustainable without the right technologies in place – so looking into next year, we will continue to see sponsors evaluating how to optimize the “business” side of clinical trials.

Improved access to clinical trials (diversity)

Diversity in clinical trials has been a hot topic recently. The way to diversify the patient pool to get more participation from previously less-represented groups is to improve access for everyone. This means supporting advocacy and awareness campaigns, which we’ve seen the start of, and will continue to see more of into next year. This means using technology to minimize the burdens on patients such as transportation to get to sites, upfront costs to participate such as childcare, time off of work and more. Improving diversity starts with education and will rest on improving access.

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More access to trials, an increase in digitalization, and much more are on the horizon for the industry in 2021.

Clinical Trial Industry Predictions

	“Partnering for Success” was the theme of the recent 

, a top conference for shared learning and networking opportunities for clinical research sites, sponsors and CROs in the region.

	I was pleased to moderate an engaging panel of experts on “Using Technology to Power Up your R&R,” which identified industry and site pain points and identified new solutions across the clinical trial lifecycle. In this short article, I’ll share some of the key takeaways from the event to illustrate how you can further position clinical research stakeholders for success. 

The State of Clinical Trial Patient Recruitment & Retention

	As the industry talks about making the clinical trial experience more patient-centered, clinical trials are becoming more complex for sites to conduct and more demanding of patients. While researchers look to unlock the benefits of personalized medicine, increasingly specific inclusion criteria make it harder to recruit eligible patients from one’s own clinic. As a result, patients are making more – and longer – visits for a greater number of procedures to be completed.  

	The panel and audience agreed that this dynamic has made it more difficult for sites to recruit 

retain patients in clinical trials, making the already difficult task of estimating recruitment for a site all the more challenging. If enrollment estimates are left unmet, studies can take longer and increase costs for all parties involved. 

	Incorporating new technology can optimize clinical development – streamlining once manual and time-consuming processes for sites and eliminating barriers for patients. Yet, the varied nature of sites, indications and broader research dynamics create differing needs, and as a result, there isn’t a one size fits all technology solution for clinical trials to address recruitment and retention challenges. Instead, the panelists agreed that various technologies can be implemented to address different facets of this complex problem from patient identification through engagement. 

	One area of consensus amongst all attending the session was the value presented by technology must not supersede the patient-clinician relationship. Technology instead must be used to create a more personalized level of care, rather than implementing technology for technology’s sake. The lively panel discussed programmable rideshare, automated visit reminders and timely payments as just a few examples of ways to augment the patient experience through technology. Afterall, creating tools that show clinicians care not just about study protocol, but the participant’s overall health and state of mind can help to retain patients, curbing drop out rates that leave site personnel looking for a proverbial needle in a haystack to meet their patient enrollment quota. 

What’s ahead for EU technology adoption?

	The session demonstrated that although clinical trial protocols are getting more complicated, recruitment and retention can be improved by shifting procedural efforts and automating processes using software. However, sites are setting their sights on further improvement. 

	Clinical research sites today aim to become more professional in their service delivery. It’s not enough to just have access to technology tools, they need to be integrated with their existing clinical trial technology ecosystem. They desire a consultative approach with expert industry partners - introducing best practices for a successful implementation and ongoing process optimization. Ultimately, sites and their clinical trial research personnel want to deliver the best possible experience to patients. Utilizing technology can help the site be more responsive to patients, enabling them to connect both at the clinic and remotely.

Research identifies pain points, fuels improvement

2018 SCRS-Greenphire Financial Pain Points Survey

, recruitment was a top concern voiced by sites. However, by effectively leveraging technology, the overall patient and site experience can be drastically improved. 

	You can participate in the next round of SCRS-Greenphire research now underway. We encourage you to take the 

to help us innovate new solutions to sustain global clinical trials. 

CEO of Greenphire, Jim Murphy, shares his takeaways from 2019 SCRS European Site Solutions Summit and illustrates how to further position clinical research stakeholders for success. 

Using Technology to Power Up your Patient Recruitment & Retention

	Clinical trial sponsors, sites, CROs, and even participants are asking: what will 2019 bring for clinical trials? Jim Murphy, CEO of Greenphire, shares his predictions on developing industry trends-and how sponsors and sites can avoid roadblocks that can negatively impact their future success. These predictions include:

The evolution of ‘siteless’ and hybrid trials

	While transportation services such as those offered through Lyft and Uber will become a standard offering for site-based clinical trials, we’ll also begin to see a shift towards more site-less and hybrid trials, in which participants will not be required to travel to a clinic for all study milestones, but rather connect with the doctor/site remotely. Healthcare technologies such as Omron HeartGuide, ActiGraph, and Medisafe offer virtual and self-monitoring solutions that can gather data about sleep duration and quality, blood pressure, blood sugar, activity levels, heart rate, and more. With these remote observational opportunities, clinical data can be transmitted to sites electronically while consultation can be done over the phone and medications can be sent via mail. As siteless and hybrid trials become customary, keeping participants engaged throughout the life of a trial may prove to be more challenging. Therefore, sponsors and sites will need to assess and adopt new innovative ways to improve engagement and will be well-served to evaluate digitizing the entire clinical trial experience in order to introduce efficiencies and improve retention.

The implementation of data privacy legislation 

	With recent global regulations being enacted, guidelines and regulatory requirements are becoming increasingly strict, requiring heightened data capture and sharing practices to be implemented. In Europe, GDPR will remain a core focus for sponsors, sites, CROs, vendors, etc., requiring an understanding of differing country-level interpretations. Similarly, in the U.S. we may see more individual states implementing additional data privacy legislation as California has done with the California Consumer Privacy Act (CCPA). New and evolving regulations will ultimately drive strengthened data privacy policies, system architectures and further due diligence to ensure compliance across all healthcare stakeholders.

Investment in a centralized, global investigator payment solution as a standard will become closer to reality

billions of dollars are spent conducting clinical trials

; yet manual and siloed systems prevent stakeholders from knowing where every cent is going. Sponsors and sites will begin to prioritize clinical trial payments as a budget item with an increased emphasis on improving financial control and overall visibility. By standardizing and centralizing global investigator payments, sponsors can better ensure that clinical trial-related payments are executed consistently, accurately, and in compliance with financial regulations around the world. 

The use of business intelligence to support feasibility will become standard

	There is a growing desire for better insight into clinical trial data trends that can support feasibility teams as they try to predict data flow, timelines, costs, and outcomes. Through the use of technology solutions that aggregate and use data in a smart, dynamic way that can be shared with other interconnected software systems, sponsors will be in a position to make better business decisions. More accurate business intelligence will result in enhanced forecasting capabilities that can be used as a baseline for future studies and in support of feasibility and ultimately smarter clinical trials.

	One thing we can all agree upon is that getting participants to and from a clinical trial is a basic requirement. However, complexity with regards to therapeutic area, participant age, and trial location can make this a challenging, cumbersome task for the site and participants. 

A recent survey from the National Institutes of Health

 notes “lack of transportation” as a key barrier, particularly among certain participant demographics. Even if sites agree to take on travel as part of their study, coordinators are not travel agents and don’t readily have access to systems to arrange the best travel accommodations, especially on a global scale. Nonetheless, quality transportation remains a challenge and impacts retention. In 2019, I predict that more sponsors and sites will integrate travel solutions into existing technology platforms, reducing administrative burdens, and eliminating logistical hurdles to clinical trial participation.

Technology: Fueling clinical trials of the future 

	As the clinical trial industry continues to embrace technology in 2019 and beyond, we expect sponsors put a heightened emphasis on adopting innovative solutions that introduce efficiencies into clinical trials. This effort will target key issues such as increasing participant engagement and retention, reducing administrative work that distracts from research and participant care and enhancing financial transparency for added control. The industry is constantly evolving and innovation is a key factor in driving change. With new ideas and technology, we will see increased efficiency and improved transparency for optimized capital management. This will ultimately enhance the way clinical trials are run, resulting in improved healthcare world-wide.

https://www.igeahub.com/2018/08/28/evaluation-of-clinical-trial-costs-and-barriers-to-drug-development/

Six Predictions for 2019

	Over the past 10 years, clinical development programs have worked to engage and enroll an increasingly diverse and international sampling of patients. However, working with research sites around the world can increase complexity, compliance risk and coordination challenges in an already demanding environment. Technology can automate manual processes to address many of these challenges, but only if that solution has the flexibility to deliver benefits across a diverse array of markets. What works for a US-based investigator may not be valuable for a site outside the US.
	
	Payment automation solutions that are designed to optimize global research site performance and sustainability provide sponsors and CROs the ability to improve trial effectiveness by enabling more efficient, accurate and timely site payments and patient reimbursements around the world. During a Site Advocacy Group (SAG) hosted by the Society for Clinical Research Sites (SCRS) and our team, site staff from around the world discussed the opportunity for payment automation at their research site. 
	
	Despite the diversity of roles and geographies among the group, there were many common themes, including:

 Monthly site payments are strongly preferred. There is a common misconception that sites outside of the US would not welcome a monthly payment cycle. During the meeting, however, there was a resounding demand from the group that 30-day payment terms were critical to the site’s ability to effectively support a trial. So why the disconnect? The problem is that with traditional site payment processes, there is a great deal of work that goes into compiling and the invoices and submitting requests for payments. This can be a daunting task if it needs to be done each month. When invoicing is automated and payments can be triggered by data, monthly payments are seamless, without additional work for all involved.  

Pass through expenditures are burdensome.

 The ability to request and track payments for pass through costs via an easy-to-use portal is extremely valuable. The common challenge that the sites voiced was getting paid from their sponsors or CROs for costs that fell outside of their contracted agreement. On average, according to SCRS, these costs account for about 30 percent of the costs in a clinical trial. Sites were very optimistic about the impact that simplifying the pass through expense management process could have on site operations. Too often, the site staff who is chasing down these payments are also responsible for patient care. Through site payment automation, this work is taken out of the hands of the site staff to keep them focused on the trial and patient experience.

Patient reimbursement drives retention and engagement.

 Reloadable debit card-based patient reimbursement and stipend payments were seen to dramatically impact retention and eliminate manual administrative burdens. The sites that participated in the discussion had either already had a favorable experience with a debit card-based patient payment solution or were eager to learn more about automating patient reimbursements and stipends.

Close collaboration with ethics committees will support regulatory compliance.

 Stipends and reimbursements are permitted by ethics committees in the EU and are increasingly becoming a global standard in clinical research. Given some misconceptions present in the CRO industry, there was extensive discussion regarding the pre-requisites to stipends and reimbursement use in the various EU countries and surrounding regions. The sites represented in this diverse group agreed that the one prerequisite to stipend and reimbursement use is proactive engagement with the ethics committee.

Communicating the value in a new solution is critical to acceptance.

 Sites are willing to use new software if the benefits are clear. All too often software is introduced to a site without a clear communication on the value it brings to the trial and clinical operations. When sites have an opportunity to really learn why a solution is being introduced – for faster payments, easier reporting, patient retention, they are more likely to adopt the technology.

	In addition to the SAG, our team worked with the SCRS to conduct market research, surveying more than 700 global sites, to further explore the issues discussed in the meeting at a macro, global scale.
	
	The findings of this research validated what was voiced among the group:

		63% of sites prefer electronic payments

		84% of sites prefer payment in thirty days or less

		44% of sites employ personnel involved in accounting who also have other study-related duties

		74% of sites report that personnel spend more than 15 minutes per patient visit on accounting activities

	In conclusion, and without much surprise, in order to successfully support the globalization of clinical research, it is imperative that sponsors and CROs empower research sites around the world and treat them as valued business partners. Timely and automatic payments, access to financial information, with reduced manual processes can eliminate the resource drain that is distracting site staff from patient identification, recruitment, retention and care.
	
	By 

In order to successfully support the globalization of clinical research, sponsors and CROs must empower global research sites and treat them as valued business partners.

Jim Murphy

Articles

Clinical Trial Industry Predictions

Using Technology to Power Up your Patient Recruitment & Retention

Six Predictions for 2019

Global Research Requires Global Payment Solutions