Life Science Leader
By Rick Farris, COO at Health Decisions
February 2010 - Each year, RFPs from hundreds of pharma companies and biotechs flood the inboxes of CROs everywhere. The RFPs invite proposals to test innumerable small molecules, biologics, and devices spanning the full range of human health conditions, from phase 1 safety testing to phase 3 confirmatory testing and phase 4 postmarket investigations.
Although this flood of RFPs reflects the variety of research needs in drug development, collectively the RFPs have an impression of sameness — almost all require CROs to submit proposals based on performing the same services in the same way on the same schedule. While this is probably the most efficient way to weed through stacks of submissions from competing CROs, many pharma companies don’t realize they are inadvertently limiting their selection criteria to a few short-sighted items, which are often largely inconsequential to the overall success of the trial. To judge from the RFPs, the main quality sponsors seem to want in proposals is uniformity, even if it means missing out on the latest research innovations that could ultimately improve their studies’ success rates. This uniformity is so pervasive that one recent RFP came as a welcome shock.
The renegade RFP did not require CROs to conduct the planned study in an identical, predetermined manner. Instead, it simply described the study’s goals and challenged CROs to achieve them with maximum efficiency and value. While it makes intrinsic sense for an RFP design to ask for what it wants and expects for its trial’s outcome, this emphasis on efficiency and value over conformity marks a radical departure from standard practice.
Efficient RFPs vs. Efficient Trials
Given that every sponsor wants maximum efficiency and value, why did an RFP that asks for those things come as a shock? There can only be one answer. Over the years, typical business pressures and time constraints have shifted the focus of procurement efforts from optimizing trials to simplifying the review of proposals. This focus has paid off, in its own way. Viewed in isolation, the current RFP process is a shining, institutionalized example of corporate efficiency. It minimizes the time, effort, and resources required to review proposals and award a contract. With services specified as the same, there is no need to spend time and expertise weighing the value of solutions beyond the RFP’s narrow criteria, leaving little to compare but price.
This would be ideal if the success of pharma companies hinged on the efficiency of reviewing proposals and not on the overall value of clinical studies — a factor which is rarely reflected solely in the price of the CRO. To extract the greatest rewards from their pipelines, sponsors must ensure that the RFP process serves this end above all others. The lone RFP stood out by doing exactly that — it shifted its emphasis from uniformity of proposals back to optimizing studies.
Uniformity As A Barrier To Efficiency
While the RFP process evolved to require greater uniformity, clinical researchers have developed new techniques for improving efficiency and maximizing the acquisition of knowledge. The pace of innovation has increased in recent years, and research specialists are rising to growing market challenges with adaptive methods, faster and more accurate data capture, and instantaneous global communications that enable unprecedented levels of efficiency. But many in-house research groups and traditional CROs remain unaware of new advances or are ill-equipped to incorporate them into their standard procedures. These groups know little about what they’re missing, so the typical RFP process seems sufficient to them.
But for innovative CROs with the know-how to take advantage of recent advances, the standard RFP process is a barrier to showing sponsors the full benefits of their capabilities. An alert and industrious CRO can compile the best techniques and capabilities observed across its full catalog of experience with multiple sponsors and can apply this knowledge to improve the trial at hand. However, these CROs seldom get a chance to make the case for conducting the study in a different and better way.
Although many pharma companies do not realize it, their RFPs block the path to greater success. Pharma companies and innovative CROs have a strong shared interest in refocusing procurement efforts to maximize the efficiency and value of clinical studies, not the review process. Given today’s prevailing practices, this requires nothing less than RFP reform.
RFP reform must start with sponsors better understanding what they could be getting from their studies. For example, everyone recognizes the importance of minimizing risk. However, RFPs rarely ask CROs to identify potential risks or propose specific solutions for diffusing them. On the contrary, RFPs often require CROs to follow specific methods that keep risks at typical, taken-for-granted levels. These sponsors don’t understand that there are new ways to dramatically reduce risk, and their RFP design prevents them from sizing up their alternatives.
The Capacity For Managing Pain Points
Although RFPs should invite CRO input on a variety of specific trial elements, their first demand should be identifying how a CRO will truly “manage” the study. This means insisting on modern, proactive management techniques rather than the passive wait-and-see approach that is commonly accepted as standard in clinical research. For example, sponsors should ask how and when each CRO intends to address the major pain points that often compromise timelines and data quality:
Exactly how will the CRO track enrollment status at each site? Will updates be daily or less frequent? Does the CRO have a systematic approach that has worked routinely in previous studies or only ad hoc solutions put together after the sponsor asks?
Does the CRO accept the occurrence of errors as standard, correcting every query in isolation on a one-at-a-time basis? Or does it promptly identify query trends and address the causal factors? This reduces query rates, shortens monitoring timelines, and improves data quality.
Can the CRO propose a better alternative to traditional fixed-schedule, on-site monitoring? When RFPs dictate a predetermined monitoring schedule, the benefits of new developments like real-time remote monitoring, better site performance metrics, automated validation tools, and enhanced resource allocation capabilities are lost.
Will the CRO’s monitors work from a rigid schedule of closeout visits, rationing attention equally among sites regardless of variances in workload? Or will the CRO keep a running tally of work remaining at each site so it can assign attention where necessary? The ability to forecast each site’s monitoring needs in a study’s final stages optimizes resource allocation and prevents the worst-performing sites from extending timelines for the entire study. Does the CRO even recognize the possibility of such proactive management at closeout?
Does the CRO address database lock solely with a major effort at the end of the study, or will it proactively identify and eliminate errors at the source, before they can cause last-minute delays? For sponsors to achieve seamless database lock, RFPs must be designed to capture a CRO’s ability to preemptively plan from day one.
Statistical advances make it possible to adjust study design in midcourse using data collected on a rolling basis. Such adjustments include reestimating sample size to ensure that it’s neither too small nor too large, more quickly identifying optimal doses by terminating unsuccessful arms early, and combining trial phases to reduce dead time. These methods aren’t suitable for every trial, but an experienced, knowledgeable CRO can help sponsors plan appropriate design adaptations.
Recasting the Traditional RFP
Most procurement personnel are likely too busy complying with institutionalized procedures and generating RFPs to meaningfully consider whether their CRO selection process is optimal. Perhaps they’re not often exposed to new research techniques through their tasks. But even if they do have the perspective to recognize the need for RFP reform, they probably lack the authority to mandate improvements.
Therefore, RFP reform must come from above. To make sure they’re asking the right questions, executives should start by seeking a wide range of opinions:
- Consult with multiple specialists familiar with the latest innovations in clinical research. A single guru may not have exhaustive knowledge or may have personal preferences that aren’t the best option for a specific study.
- Read up on adaptive methods and other recent advances, or assign someone to do so.
- Insist that the new RFP process allow CROs to propose better methods — to take their best shot.
- Train procurement professionals to compare proposals based on value rather than price alone. Price remains in the equation, but reducing risk and time to market are more important for many studies and can have a much greater effect on overall profitability.
- Cast a net for innovative CROs whose services incorporate recent advances in adaptive techniques and/or operational efficiencies. Invite them to submit proposals on future studies.
Ask More From CROs
If you are a sponsor accustomed to getting what you ask for, it may be difficult to realize that what you’ve been asking for isn’t what you need. But if you find typical study timelines and costs distressing, you should welcome the opportunity to rethink the RFP process. Place the burden on CROs to offer greater contributions to the success of your studies and the attainment of your goals. If you find choosing the best proposal a bit more difficult, it will mean you have a greater range of options for optimizing your study. Over time, the choices you make among more clearly identified options are bound to yield better results.
About The Author
Rick Farris is COO at Health Decisions, a full-service CRO specializing in Agile Clinical Development. He holds a degree in Computer Science from East Carolina University and has almost two decades of experience in clinical research operations and software systems.