whitepaper

the efficiency challenge in clinical drug trials.

randstad life sciences

Life sciences companies today seeking to bring new drugs to market face daunting challenges, chief among which is the exorbitant cost — over $2.5 billion on average — of developing and gaining FDA approval for a new drug. And of the drugs that do make it to Phase I of clinical testing, it is estimated that less than 12 percent will ultimately go on to receive approval. Add to that the difficulty of ballooning global regulatory requirements, which continue to expand both geographically and in terms of content, and the picture is complete.

To confront these challenges, it is incumbent upon life sciences companies to find ways of improving the value — and ROI — of every dollar they spend on research and development (R&D) efforts. That is one of the reasons many organizations today are keen not only to implement metrics and tools that will enable them to more carefully evaluate the ROI for any budget allocated to R&D initiatives, but also to look for strategic partnerships that enable them to outsource clinical trials — either in whole or in part.

Yet selecting the right partner is seldom easy, and the market is cluttered with a variety of different types of partner organizations — each with capabilities and operating models designed to serve the needs of some sponsors or projects better than others. In other words, there’s no “one-size-fits-all” solution.

But given the magnitude of the challenges, many sponsor organizations today are critically re-evaluating their outsourcing options, brainstorming alternate models and in some cases even radically challenging conventional approaches. Of course, there are a constellation of factors — ranging from the the culture of the sponsor organization, to its existing infrastructure for clinical trial management and the depth of its pipeline — that necessarily come into play when selecting a strategic partner.

This whitepaper examines these factors in detail and frames them in the context of efficiency — speed, quality, cost — to help sponsor organizations alleviate bottom-line pressure, expedite clinical trials and achieve their strategic goals.

FSP versus CRO: what’s the difference?It’s no secret: drug companies today are pursuing new ways of working with strategic outsourcing partners. They’re also demanding faster output — on leaner budgets and with higher quality standards — than ever before.

How can strategic partners live up to these expectations and deliver the most value? Before turning to answer that question, let’s clearly differentiate between the two primary types of outsourcing groups: functional research providers (FSPs) and contract research organizations (CROs).

Sponsor organizations usually seek out an FSP when they wish to outsource functions such as clinical trial management services, site monitoring services and medical writing services across a portfolio of projects. Because the FSP model has the potential to increase efficiency without compromising quality, it has gained popularity in recent years. And because it’s flexible, with resources that can ramp up or down on demands — and most of the risk borne by the FSP — many sponsor organizations view it as the model best suited for an era marked by regulatory uncertainty and political and economic disruption.

With a CRO model, on the other hand, sponsor organizations usually outsource most, if not all functions of a trial or project, from conducting and overseeing trials to collecting, analyzing and reporting on findings. In general, CROs expect to sign longer contracts with sponsor organizations — four or five years is common — than FSPs, which enables them to maintain higher margins and deal with less cancellation-related volatility.

important considerations when choosing a strategic partnerAsking questions is always a smart way to get to know someone, and it’s no different with an outsourcing partner. But what are the right questions to ask?

Capabilities, specialties, site experience — any of these areas, which impact efficiency directly, are a good place to begin. For instance, imagine if a sponsor organization knew that an upcoming trial would take place at a specific site. Now, if that sponsor organization could identify an outsourcing partner that had previously worked with, say, principal investigators (PIs) or co-principal Investigators (Co-PIs) at that very site, that might pay off big time in the end. After all, the outsourcing partner would likely be aware of potential site-related pitfalls ahead of time, and therefore be able to help the sponsor organization take preventative measures and mitigate against risks.

Beyond risks, when it comes to specialties like clinical trial management services, site monitoring services or medical writing services, it’s a good idea to consider the functional areas of expertise of the teams that a potential partner can provide. For example, for a clinical trial related to oncology, it would be important to identify an FSP with qualified resources on hand who have worked in oncology in the past. That leads to synergies.

Finally, for strategic partners to help shave hours, days — even weeks — off of clinical trial timelines, they need to have qualified, trained and experienced resources on hand. Unfortunately, the high rate of turnover associated with CROs — hovering around 25 percent in recent years — often makes that challenging.

selecting what to outsourceIn general, sponsor organizations opt to outsource functions that are for the most part tactical. The idea is that strategic outsourcing partners, by specializing in a reproducible process, are able to create economies of scale and support the needs of sponsor organizations — and do so far more efficiently than these organizations could on their own.

Outsourcing individual functional services grants greater freedom to sponsor organizations, while, at the same time, these organizations are able to retain more control than they likely would with a traditional preferred provider relationship like a CRO.

Companies that wish to retain a high degree of control over project delivery generally favor partners that deliver on an FSP model. Within the scope of a clinical trial project or program, it also has the potential to increase efficiency and flexibility, without compromising quality.

An outsourcing partner with specialties like clinical trial management services, site monitoring services and medical writing services can help sponsor organizations quickly ramp up or ramp down, and build customized solutions on a sponsor-specific basis. On the other hand, even those CROs that offer functional outsourcing services usually have limited ability to customize services based on needs of clients — which is one of the reasons it is not uncommon for sponsor organizations to complain that they feel “unheard” with CROs.

Finally, it’s important to understand the decision to outsource as simultaneously a decision not to invest in certain things. Whether that thing is strategic or tactical, such a decision can have big consequences down the line.

more efficient resource allocationFrom the outset, in order for sponsor organizations to understand the differences in efficiency afforded by different outsourcing models, they first need to think in terms of their long-range strategic goals. For instance, FSP partners often cost more up front, but deliver substantial savings down the road.

For drug companies looking to add — or “bolt on”— new capabilities to their organizations, FSPs offer superior value. They can be integrated into — or supplementary to — in-house capabilities; they can work as an extension of existing teams at sponsor organizations; or they can become the team.

While working with a trusted partner can yield huge benefits, it can also entail benefits that are as minor, and yet essential, as having everyone aligned on what a common term like “EOD” means. Is “end of day” 6 p.m. EST? Or is it early afternoon, so that a key stakeholder has time to review and pass it along?

FSPs, unlike CROs, are typically able to deploy resources who have worked with the stakeholders at sponsor organizations in the past, who understand and are familiar with the organizations’ processes and procedures — and therefore require minimal time to onboard. That kind of nuanced understanding creates opportunities to maximize efficiencies and deliver value.

Plus, by implementing KPIs that measure the health of the relationship — as opposed to only measuring specific deliverables — and using qualitative assessment tools like project surveys, strategic partners and sponsor organizations can ensure they understand how to improve the quality of their partnership. Constructive feedback and suggestions around best practices are another value-add — and a good example of how preferred partners can deliver in ways that go beyond the service-level agreement (SLA).

a more efficient approach to risk managementTo those outside the pharmaceutical industry, the ascending average timeline for completing each stage of a clinical trial might seem mind-boggling: one year for Phase I trials, two for Phase II and three for Phase III trials. How can sponsor organizations achieve greater efficiency and expedite trials?

It is also not uncommon for drug development projects to be sped along prematurely — the reasons are cloudy, often having to do with factors internal to the sponsor organization — only to fail once they reach more advanced stages of clinical development.

That’s where strategic partners come in.

For instance, imagine a drug company that has just completed long and arduous Phase I and Phase II clinical studies. Now, the company is getting ready to gear up for a large Phase III study: Even though there is no guarantee that the study will ultimately be greenlit, the reality is that, given the amount of time and money that has already been invested in the project, the drug company simply cannot afford not to be prepared to conduct the Phase III study.

In such a scenario, there are clear advantages to outsourcing with an FSP partner. Most of all, by partnering with FSPs, sponsor organizations are liberated from the risk of paying for latent capacity. FSPs, because they bring redeployable resources to clinical studies, are able to shoulder the burden of risk. If, conversely, the sponsor organization had chosen to bring on full-time staff in order to run the Phase III trial, a cancelled trial could only mean significant operational costs from extra headcount, underutilized resources and more.

Given that the average cost of a Phase II clinical trial varies from $7 to $19.6 million, while the average costs of Phase III clinical trials range from $11.5 to $52.9 million, efficiency is the name of the game. Yet, outside of what are in most cases the busiest and most resource-intensive periods of clinical trials — that is, study startup and closeout — the variability of the clinical trial lifecycle can be difficult to predict or plan for. That is why sponsor organizations often lean on FSPs for on-demand resources who can be ramped up to help prepare for an audit — an important consideration, given that $1 of every $2 in a clinical trial goes to creating audit trails and maintaining clinical sites. And again, the risk of latent capacity is mitigated.

key takeawaysOngoing success in clinical trials requires a perspective that balances short- and long-term needs, and frames differentiating factors between FSPs and CROs in the context of increasing efficiency to achieve critical goals. A strategic partner can even be an instrumental part of that planning process.

However, given that only five out of every 5,000 drugs that enter preclinical testing eventually make their way to human testing, the mandate for sponsor organizations is clear: improve the drug development process, get more drugs to market and do it faster. Carrying out better clinical trials is one of the keys to achieving that mandate — and it starts with selecting the right partner, one that has an operating model that closely aligns with the goals of the sponsor organization. Ultimately, only by identifying costs, and eliminating the efficiencies that are their root cause, will sponsor organizations finally see advancements in their drug development process, and reap the financial rewards of greater innovation in medical product development.

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