A recent post made the point that efficient patient recruitment is the most important factor for completing clinical trials on time and making new medications available. While difficult study designs are a factor in recruitment, the way sponsors manage clinical operations to field those challenging projects makes all the difference.
Probably nothing else in clinical operations affects recruitment and progress toward completion as much as a pharma's skill in managing the other companies that provide assistance on drug trials. Everyone knows that independent clinics and medical practices recruit the patients and administer the test drugs for trials. But pharmas also use many other kinds of companies to provide trial services and they stand between the sponsors and the trial sites.
Some vendors make sure that study sites receive the proper supplies in the right amounts for running a particular study. Not enough supplies mean a clinic may be unable to test a patient when she arrives for her appointment. If the vendor delivers too many supplies, a clinic will have nowhere to put them, possibly causing the materials that require refrigeration to spoil.
The data that study sites regularly obtain as a trial progresses must be transferred and uploaded to an electronic database that will permit efficient analysis by statisticians and others. Here too, pharma sponsors use specialized data vendors.
Dealing effectively with all the specialized vendors requires the nurses, coordinators and investigators at the study sites to receive training on the correct procedures for each vendor, on every trial. Alliance management involves coordinating the inevitable conflicts and time requirements among the vendors so that site staffs can use their time to enroll patients and administer the study, rather than struggling with several vendors on each study.
Even with the best vendor coordination, problems and questions always arise that perplex the staffs at trial sites. When coordinators at the sites try reaching vendors by phone to resolve such issues, the service they get tends to be erratic, even as efforts to resolve matters drain their time and distract them from their efforts to screen new patients for the study.
Contract research organizations (CROs) are the largest and often the most significant member of this vendor alliance. CROs serve as the soup-to-nuts vendor for clinical trials because they offer a broad range of services, up to and including what amounts to a turnkey job. Approximately 50% of clinical trials are outsourced in this manner and the fact that finance, at least indirectly, manages all pharma operations leads some observers to project this proportion will rise to 70% by the end of the decade.
Some pharmas have developed what they term as "strategic partnering relationships" with one or two CROs, meaning these anointed organizations are automatically assigned to ride herd on every compound the company takes into clinical development. From a financial manager's point of view, this sort of arrangement has the benefit of removing numerous full-time employees from the company payroll, thereby converting a fixed expense -- one that would include benefits, 401(k) matching, and other perks -- to a variable expense that managers can terminate immediately after deciding to end a study.
The downside of relying heavily on CROs is that these multibillion dollar companies charge sponsors a premium for their services, so that trials wind up costing more. Then the high rate of personnel turnover among CROs (up to 20% annually) and their unanticipated lack of expertise in some areas also means that they wind up taking more time to successfully complete a trial.
Outside of those potential pitfalls, anyone who's ever used a building contractor to do some significant construction or remodeling on his/her house has heard the dreaded term, "change-order fee." In this case some observers in pharma make the case that CROs even have an economic incentive for problems to occur. Although CROs will help sponsors design and implement the many aspects of a clinical trial, they still earn 25-30% of their gross revenue from change-order fees demanded when sponsors need to adjust those same factors that the CRO originally put in place.
None of this means that CROs as such fail to provide useful services or that those companies are ripoff artists. To the contrary, the checkered performance of CROs indicates that the outcome in any given case depends on the way sponsoring pharmas manage the arrangement. While alliance management directly affects the pace of patient recruitment, sponsors cannot count on a CRO to coordinate these specialized service companies in a manner that will solve the diverse problems that clinical site staffs encounter. Many CRO personnel lack the experience to address those problems and those who are savvy barely have the time to finish their routine, check-the-boxes duties. The result is that every extra minute a nurse coordinator in a clinic has to spend on the phone, inquiring how to upload recorded data, represents one less minute she can spend talking to a patient who is a potential candidate for the sponsor's study.
In practical terms sponsors must demand that their CROs use only experienced managers and clinical research associates (CRAs) on their studies and then monitor compliance with that agreement. Part of securing an optimal agreement also means that sponsors must place strict limits on the number of study sites each CRA serves.
Essentially the growing outsourcing of clinical operations has created a Catch-22 for the sponsoring pharmas. The sponsor's full-time employees that work on the study teams are discouraged from directly interacting with study site staffs and the vendors. Instead they are admonished that such work is the CRO's responsibility. The CROs, for their part, disdain the work of alliance management because the profit from it falls below their threshold, while fees from a change-order are far more lucrative. So while CROs, when functioning at their best, can play a useful part in the clinical trials required to develop new drugs, several factors make it unlikely they can manage the alliance of vendors that interact with clinical sites. Alliance management then falls between the stools, thereby distracting the staffs at study clinics and delaying patient recruitment.
Pharma's ability to solve this dilemma will help control the rising costs of clinical development and make life-enhancing, new medications available sooner. Some sponsors have welcomed our input and the tactics we recommend for alliance management. After all, effective alliance management reduces their costs on matters such as change-order fees and, by speeding patient recruitment, brings new products to the market sooner, where they can generate revenue. Other companies prefer to go along with the current drift. It remains to be seen whether the historically slow-moving pharmaceutical industry can address this issue promptly.
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