28-29 - Clinical research outsourcing: prioritising safety

When pharma companies outsource clinical research services to third parties, it can be easy to make assumptions about what’s included. Too often, clinical research organisations (CROs) promoting full-service outsourcing skimp on safety provisions. That’s not to say that they are deliberately lax, but rather that formal safety provision is an add-on – rather than something integral and embedded within everything that they do.

The potential danger here is the safety team is not sufficiently knowledgeable to ensure complete compliance, or to support clinical trials both comprehensively and efficiently.

Global CROs usually comprise a large network of service providers serving each respective local market, which may on first sight seem to build confidence at multinational pharma companies. Yet there is often a disconnect when it comes to using that network effectively to ensure clinical safety.

While, combined, the international partner network may know everything about how to get the trial registered and how to run it, frontline teams may be less experienced with safety. They may suggest a less than optimum approach or, through inexperience, request time to consult with local National Competent Authorities on a safety question.

This, in turn, can give rise to inefficiencies and potential non-compliance: before long the trial is running like an unstoppable train and safety services must try to catch up. Delays and inefficiencies have led to pharma businesses having to double or even triple their clinical safety budget.

There are several practical steps that can support pharma businesses looking to put safety front and centre of clinical research outsourcing strategy.

First, it’s important to avoid a one-size-fits-all approach. Each product has a specific safety and efficacy profile. Pharma businesses vary in size and focus of course – from small biotechs to orphan oncology to generic bioequivalence – all requiring specific expertise on varying budgets.

At the same time, some products may have particular risks that require study sponsors to look for certain adverse events and do some additional monitoring or additional reporting.

At the other end of the spectrum, some trials are run with products that are already well established on the market, with a known safety profile. Perhaps they are now being tested for a different patient group or for a new indication. In this case, the safety approach may be a bit more hands-off, focusing more on a general oversight.

If companies don’t get this right, it can lead to inflated costs. For example, a small biotech company working with a large company that offers safety as an adjunct may find itself paying for systems and processes that are over and above what it needs.

This can lead to a lot of unpleasant budget surprises for the client, arising from additional meetings and customisation. When choosing a supplier for outsourced services, this type of business would need to focus on a requirement for consultancy and partnership.

Effective communication with the service partner is crucial, too. An efficient exchange of information should help nip potential issues in the bud and keep ahead of any issues that might develop into a safety risk to patients or a budget drain on the study. Communication issues cost money and may even impact the quality of the safety part of the trial.

Having an oversight of the activities of the vendor is a legal sponsor responsibility, so should be facilitated and supported by the vendor. One way to guarantee that will happen in an outsourced arrangement is to make sure you will be working with a project manager who is not focused entirely on the technical side of things, but is also focused on communication with the client. Time for communications, specified communication touchpoints, explaining and facilitating communication between the technical staff and the sponsor, must be accounted for explicitly in the budget.

For many vendors offering outsourcing services, this type of partnership approach to safety demands a cultural change that they have yet to make. So, when assessing reference sites, look for evidence of very frequent communication – multiple meetings and not just with the technical team and the study execution team, but also between the project manager and the contact person on the sponsor side. And check that communications highlight the pain points and provide clear actions, rather than just comprising masses of unexpurgated data.

Clinical safety vendors range from small companies offering services in a single region to the big CROs offering clinical safety as an add-on service. The bigger the company, the more substantial the global footprint. Yet size is not always an indicator of best service.

The larger players often fail to make optimal use of their local network, to ensure the study sponsors have the correct and most up-to-date information for full compliance – and gain from optimum efficiency.

The reasons for suboptimal use of local networks range from slow knowledge transfer processes, long reporting lines and circuitous reporting routes, and no drive to keep costs down.

Smaller and mid-sized companies often have more direct communication channels within their global network and will understand the importance of keeping sponsor costs low. They are also more likely to think out of the box and come up with creative ways to be compliant efficiently.

It is important to ask potential outsourcing partners questions about the governance of the local network. Ask difficult questions. How do you make sure that you will get the information that we need from the vendors and in a format that is usable? How do you keep oversight of the local subcontractors and vendors? Do you audit them?

Achieving consistency in safety information across studies can go a long way to driving efficiency – and safety. Ensuring data consistency in an outsourced arrangement is a challenge. Sometimes sponsors choose different vendors for each study, due to regional coverage or a specific expertise in a disease area. The downside of this approach is that safety information is scattered across multiple systems.

This makes it difficult to maintain an oversight of the safety database. Processes are less efficient as various teams all need training on different systems. At the end of the process, multiple data migrations will be needed. There’s a clear benefit in having all the data in one place, enabling a holistic view.

When CROs offer safety as an add-on service, compromises will be inevitable. Typically, the safety team won’t be suitably specialised: multitasking clinical research associates (CRAs) are unlikely to have the breadth of experience needed to ensure full compliance; nor to think laterally about achieving optimal efficiency.

Regulatory changes affect clinical trials all the time, too, so it’s important that partners are proactively looking ahead to impending and future developments. Outsourcing to partners with contacts at regulators can help here.

Consolidating all trial-related services under one roof with one vendor can seem like a good idea, suggesting holistic oversight and overall efficiency. Yet outsourcing to a vendor without specific safety expertise can be a costly step in the long run.

Clinical research outsourcing:prioritising safety

Clinical research outsourcing:
prioritising safety