Considering the number of years it takes to bring a drug from concept to market, and the number of patients anxiously awaiting for effective therapies to become available, study delays can be costly in more ways than one. Catherine Click (CC), director for clinical pricing and analysis at Greenphire, recently spoke with Outsourcing-Pharma how budget delays can slow study launches, and what technology-solutions might help clear such obstacles.
OSP: Why are budget delays so common in clinical trials?
CC: Bringing a new drug to market is time-intensive and costly; on average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion.
Budget delays and contract negotiations are a top reason why clinical trials are initially delayed. Clinical trials have become more complex; such an increase in complexity feeds into budget and contract template creation time, as well as negotiation and approval time.
For example, a study with multiple treatment arms in which each arm has a very different visit schedule and procedure being conducted is not a simple duplication effort. Depending on the number of differences, it can be almost as if creating a new budget from scratch for each arm; this adds a significant amount of time to the creation process and can also impact negation time.
Also, although some larger institutions have created efficiencies in their review processes, many have added additional layers resulting in an increase of time. These layers often include several different levels and rounds of budget and contract review and approvals which can contribute to delays.
OSP: What are some of the negative impacts a budget delay could have on a trial? These might range from obvious to less apparent—feel free to share whatever you think of.
CC: The target everyone is working towards in study start up is “first patient in,” or FPI. If you do not have all interdependencies aligned at the appropriate time in study start-up, you risk that FPI target date and often result in costly contract amendments and study delays.
If a budget is delayed, the negative impacts center on time lost and inflating costs. It takes nearly 8 months from site identification to study start up completion – an entire month longer than it did just 10 years ago. If your drug eventually goes to market, that additional month can mean millions in lost revenue.
In addition, should there be study changes, as there frequently are due to changes in trial design or a failure to meet enrollment deadlines, the amendment process kicks off the same manual, outdated budget and negotiation exchange between sites and sponsors. This can cause ongoing frustration for sites and sponsors alike.
OSP: What are sites and sponsors currently doing that leaves them vulnerable to budget delays?
CC: Existing Excel-based systems and spreadsheets commonly used today by sponsors are not sophisticated enough to forecast clinical trial budgets and interact with sites and other stakeholders around the world. It’s an outdated system being used to solve an increasingly complex need of operating a clinical trial.
OSP: Could you please provide a little detail about the different areas you suggest are important to avoid such problems:
- Technology/Process flexibility: By integrating the systems used by both sponsors and CROs with sites, you can decrease manual effort, increase efficiency and improve accuracy.
- Data reliability: Another complicating factor for study planning teams has been weak or incomplete data. Historically, teams have relied on information from “point-in-time” data in inaccessible formats. Without reliable financial information, sponsors build budgets that may not reflect country-specific requirements, nor represent the latest fair market value, which draws out the site budget negotiation process. We conducted a live webinar on 6/18, and in a webinar quick poll, data reliability was the number one budgetary challenge selected amongst participants.
- Separation from payments: The lack of communication and integration between contracts departments and payments departments is a common problem in the industry and can have time and money negative impacts. Due to the lack of communication, sometimes the way a study budget is constructed by the contracts team is not in a format that the payments department is able to issue automatic payments. If sites can’t get paid based upon what is negotiated in their contracts, then all of the work in the lead-up to contract execution is for naught. This results in FPI date milestones being missed, and a decay of the sponsor-site relationship.
Localization and visibility: If COVID-19 has taught us anything, we are living in a global society. That said, it is becoming ever more difficult to find a patient population that has not been exposed to a first line therapy or previously participated in a clinical trial. Sponsors are expanding their standard country list to accommodate, but this expansion requires a level of understanding in these countries of regulatory timelines and requirements, budgeting and contracting nuances, and how all of that factors into defining the FPI site or country target to set a study on the right path to success.
Standard of Care is not the same globally, and in some countries, it does not apply once a patient is consented into a clinical trial?
Imagine if you didn’t have to track all country nuances, and had readily accessible intel on requirements for regulatory submissions, country budgeting practices, contracting standards and timelines scaled by country or site.
OSP: How can companies like Greenphire help?
CC: In June, Greenphire announced the launch of EnvisiX, an intuitive, data-informed budget creation and negotiation solution that streamlines study startup. Powered by globally sourced investigator grant actuals and payments with an automated data return, and designed with a focus on enhanced user experience, EnvisiX is seamlessly integrated with our industry leading site payment solution, eClinicalGPS.
This integration ensures seamless collaboration through an end-to-end workflow from budget creation and negotiation to management, execution and tracking of global investigator grants - all within one application. Sponsors who use EnvisiX can accelerate study startup by eliminating the guesswork and streamlining budget build and modification processes to deliver smarter, more efficient trials.
EnvisiX is a SaaS-based solution and as such, it is incredibly intuitive to use and doesn’t require installation on individual PCs. Like all our solutions, Greenphire provides comprehensive onboarding services and training for sponsors as well as ongoing support who implement EnvisiX.
The system offers the most up-to-date data and simple workflow to build budgets, accommodate country-specific workflows and facilitate straight-through site payments using eClinicalGPS.