Sponsors outsource their clinical trial activities for a variety of reasons; they may want to add geographic coverage, focus on other core activities, or simply realize cost and efficiency savings. But how does a sponsor decide what level of oversight is appropriate? Should certain functions always be outsourced? Never be outsourced? Finding the right balance of contracted versus in-house activities can make or break a clinical trial, not to mention the sponsor’s relationship with its providers.
The rising cost of drug development has been in the news for years, and the contract research organization (CRO) industry has seen massive growth as sponsors outsource more trials and more functions in an effort to thwart these rising costs. CROs have the operational expertise and efficiency to manage a sponsor’s trials, but they can’t (and shouldn’t) be expected to have the same degree of personal investment as the sponsor regarding the success of the program. That’s not to say that CROs try to gouge sponsors (they don’t), but by nature, they see a clinical trial from a different perspective.
How to Establish an Effective Sponsor-CRO Relationship
From a practical standpoint, sponsor oversight of the CRO makes good sense. From a regulatory standpoint, it’s required. But regulatory agencies can’t tell a sponsor how to oversee the CRO, so each sponsor must determine what level is right for their organization. For small pharma and biotech companies where resources are tight, hire vs. outsource decisions are critical. An oversight model where the sponsor tries to match an internal person with each key CRO role will not only make the sponsor’s cost savings disappear, but will also drive their CRO crazy.
Yet if the sponsor is too hands-off, they could lose control of their trial and have a hard time justifying their oversight to a regulatory authority. An effective sponsor-CRO relationship is one in which the CRO team is seen as an extension of the sponsor team and the sponsor can capitalize on the respective abilities of both internal and CRO personnel. The CRO applies resources according to the project specifications, but there is no specification to tell the sponsor where/how oversight needs to take place. The sponsor needs to take into account its relationship with the CRO, its financial position and timing needs, and the relative experience of its own staff.
Sponsors need to have their own project manager (PM), even if this means one-to-one oversight of the CRO’s PM, to ensure the budget and timeline account for items internal to the sponsor. A key objective for the sponsor PM will be not to duplicate what the CRO PM does, but rather to complement those activities. Sponsors shouldn’t try to directly manage detailed timelines associated with CRO and site activities for the trial, but instead can take the CRO’s timelines and link them to other projects within the sponsor (e.g. nonclinical studies, additional clinical trials with other CROs).
Overseeing CRO Activities
What about other core clinical trial activities? Does a sponsor need to have a data management function? Does it need pharmacovigilance and medical affairs, too? One way to think about which specific functions should be internally staffed for oversight of the CRO is to consider whether those functions have implications outside of the individual trial being managed by the CRO. For example, the clinical database is likely only applicable to one specific trial, so there may not be a need to have an internal DM group to oversee what is being done at the CRO. This can be managed by the clinical team, since the technical data management expertise is being provided by the CRO.
However, the data gathered from that one trial will be used in conjunction with additional data regardingthe same product, and the CRO might not be involved in other research with that product. This necessitates having functions like biostatistics and medical affairs staffed internally within the sponsor, so the data can be analyzed across the various clinical and nonclinical programs. This doesn’t necessarily mean the sponsor needs a full-time employee (or employees) in each of these functions, simply someone independent of the CRO to have the sponsor’s interests in mind.
The decision whether to hire a full-time employee or an independent consultant should be made depending on the expected amount of long-term work in that area, and consistently with how the company generally handles human resources. Aside from considerations above, some key questions for the sponsor to ask itself are:
- Is it the first time working with this CRO? If not, how did they perform previously?
- What technical expertise is retainedin-house at the sponsor?
- Does it take technical expertise to oversee a given function at the CRO?
- Are there multiple CROs to oversee at any one time?
- What technologies are employed by the CRO to enable effective oversight?
By asking these questions ofresponsible parties at the sponsor, the company can find the right level of oversight for project needs that is consistent with the company’s culture.
Very few, if any, clinical trial sponsors manage all their own trials these days. Outsourcing models vary as much as the companies that utilize them, but one thing that remains consistent is the sponsor’s need to oversee the activities at the CRO. Small biotech companies don’t have the resources to try to replicate every position on the CRO project team; big pharma just shouldn’t. Sponsors and CROs must work together and trust each other to maximize the efficiencies gained by outsourcing to clinical trial experts, while ensuring the sponsor maintains adequate oversight and is comfortable with the study’s progress.
Head of Quality and Compliance