Earlier this fall, the U.S. Department and Health and Human Services and the National Institutes of Health issued a new rule that requires researchers to make trial data public.
While the rule focuses on clinical trial data, Jim Murphy, CEO of Greenphire, anticipates an increased focus on financial transparency in the near future.
To learn more about financial transparency in clinical trials, and how sponsors, contract research organizations (CROs), and sites can protect themselves, Outsourcing-Pharma.com talked with Greenphire about the benefits and challenges of transparency.
Outsourcing-Pharma.com: What is driving the increased focus on financial transparency?
Jim Murphy: To gain a competitive edge and advance the development of medicine, sponsors are constantly looking for areas to introduce efficiencies and strengthen partnerships with their research sites. With that, there is an increased need for sponsors and CROs to better plan and budget for their trials.
Trials have countless unpredictable expenditures – particularly related to study start up and manual operational processes. The ability to plan, project and gain insight into these costs using financial data can be extremely beneficial for the business as well as the trial.
It is worth noting that financial transparency is not new. Where the increased focus comes from today, is the growing difficulty in obtaining and sorting through data as trials are growing increasingly more complex, global and compiling even more data points. There is a growing regulatory focus on financial transparency to support compliance that further emphasizes the need for financial visibility and control.
Outsourcing-Pharma.com: How is this going to affect CROs, sponsors and sites? What steps will they have to take to be transparent?
Murphy: The entire clinical trial ecosystem is affected by financial transparency because each stakeholder relies on the other to successfully capture and record transactional data.
The complexity and globalization of today's trial protocols, which can involve thousands of patients across hundreds of sites worldwide, means that there is a clear need to centralize data and financial activities related to a trial.
By doing this, sponsors can automate the tracking of financial information related to a study and increase transparency by making this information available to all those who require access to it. Automating processes can also reduce the likelihood of human errors occurring and reduce the amount of time that needs to be dedicated to navigating complex payment processes.
At the same time, sponsors can use centralized methods to derive important information related to cost drivers and site performance to optimize cash flow management and support planning, budgeting and forecasting.
Outsourcing-Pharma.com: What are the challenges of being financially transparent?
Murphy: The biggest challenge with ensuring financial transparency comes with the common disconnects in data transfer between the sites, sponsors and CROs.
Research sites capture what is owed and track trial activity within their own systems and report this to their sponsor or CRO. The sponsor/CRO is then tasked with matching the activities up with what and how much was contracted to be paid for and then disburse funds based on that activity.
Sponsors are faced with supporting global compliance obligations with transactional reporting based on information received from its CRO and site partners, which is often captured manually and in a variety of different formats and systems. Additionally, this information is also used for budgeting and forecasting purposes, further complicating its reliability.
When thinking about a trial that can involve dozens, sometimes hundreds, of sites across the world, this is an extremely burdensome and timely process that is often manual. Without the proper reporting or supporting information, it is nearly impossible to understand what funds are being sent where and for what costs.
Outsourcing-Pharma.com: Are there benefits to being financially transparent?
Murphy: As a trial begins and site agreements are executed, an opportunity presents itself to create better projections of actual costs no matter how complex the trial’s protocol.
It’s essential that organizations can link budget data to actual costs across every clinical site to assess variances, address any issues and readjust cost expectations if necessary. Automating and centralizing financial transactions can help sponsors to do this, especially across sites in different geographic regions.
Access to real-time analytics gives trial managers visibility into enrollment requirements that have been reached and cap them if needed, to manage patient-related costs.
Additionally, the fact that sponsors can see the status of patient enrollment at each site and refine cost projections accordingly on an on-going basis, means that revised cost projections will be significantly more accurate than the initially budgeted figures.
In most trials, contracted rates and patient numbers are likely to remain static once the enrollment phase is completed, so analytics start to take on a different role once the study is operational. Sponsors need to examine costs from an operational view point, evaluating whether the trial is on track to stay within budget, looking at cash outflow needs, and examining current liabilities and payments to CROs.
Outsourcing-Pharma.com: How can sponsors, CROs and sites can protect themselves?
Murphy: Implementing a centralized solution that aggregates payment data is just the first step to supporting financial transparency. It is important that all stakeholders and end users realize the benefits of an automated solution and recognize the numerous advantages in using such technology. If the benefit is not clear, there will not be adoption.
Additionally, knowing how to analyze, dissect and digest the data is critical for budgeting, reporting and forecasting. If this is truly optimized – the advantages are endless.