Industry Viewpoints: Strategic Overview and Risk Management in Clinical Operations

12th July 2018 (Last Updated December 10th, 2018 15:54)

Dr Joachim Luithle, VP, Head Clinical Development Operations, Bayer, speaks to CTA’s Adeola Coker about risk management in clinical operations

Industry Viewpoints: Strategic Overview and Risk Management in Clinical Operations

One issue that remains a constant challenge is the best ways in which to incentivize and manage contract research organizations (CROs). With multiple challenges to overcome, it’s difficult to find the best incentive model to manage risk from external providers.

In this Industry Viewpoint, CTA staff writer Adeola Coker sits down with Dr. Joachim Luithle, Vice President, Head Clinical Development Operations at Bayer, to discuss the major operational challenges to be aware of, and how sponsors can overcome them.

Adeola Coker: What are the biggest challenges facing the industry?

Joachim Luithle: The biggest challenge – and the route cause for a lot of problems in the sponsor-CRO dynamic – is that the interests of both parties aren’t always aligned. One of the biggest operational value drivers for a pharma company is time to market. A core pipeline asset can easily lose millions of Euros in net present value for every month there’s a delay. On the other hand, one of the biggest value drivers for a CRO is the outlay between money invested – mainly personnel cost – and the sponsor’s income, such as change orders. To bring those interests as closely together as possible is the core of a contractual agreement.

AC: What are the core elements to align interests between both partners?

JL: Well, it’s very important there’s a mutual understanding of what’s achievable, for example, patient recruitment targets, as that can lead to an expected trial completion date. Doing a sponsor feasibility in parallel to the CRO in order to judge its plan and have an independent position is necessary. The discussion with the CRO leads to a contract anchor date. The quality of this point is absolutely critical and contractual measures are built around that.

AC: But how can sponsors address the continual problems in clinical research?

JL: The concept of quality by design is a core element to address potential hurdles. Issues are sometimes detected rather late and implementation of contingencies does take time. This is why costly countermeasures like new sites and countries often have little effect at relatively high cost. Creating a list of risks with mitigations and quantitative triggers is important. Some mitigations need time to prepare. The preparation might be triggered by earlier trigger points. The CRO will have a contingent budget that would allow to implement mitigations. This will allow them to stay on time and avoid penalties that would risk their margin. At the same time, the sponsor is happy to share benefits from overachieving targets if they result in a shorter time to market.

AC: Are there any additional points that matter from your perspective?

JL: Yes. There is one aspect that is more important than anything else: Quality. Quality problems can ruin your trial, delay your submission and lead to all kinds of unpleasant problems. Ensuring quality is the number one priority. Having said that, sponsor oversight needs to be done effectively. Sponsors easily add 20 percent cost on top of the CRO cost for sponsor oversight. Many sponsors force CROs into interesting mixed operating models. I think it is more efficient to allow the CRO to work according to their SOPs. Clarity on quality critical elements, and oversight on those points initiated by trigger points, is the best way to ensure quality. Therefore, a partnership relationship is key to share and proactively work on the priorities and potential risks.

AC: So planning seems to be an important element for an effective partnership with CROs?

JL: Indeed — it’s all about planning. You will always have unplanned situations. The goal is to minimize those. Planning starts well before the protocol is even in the draft stage. One problem between pharma companies and CROs can be that the protocol for a trial is created by science-driven people at the pharma company. Operational input might be missing. If this protocol is then sent to the CRO, this can result in delays and frustration.

A project management system that aligns protocol maturation levels and operational progress, as well as input, is key to avoid such problems. The protocol needs to be checked what’s feasible and patient burden. Also, the set-up of data capturing systems needs time. Vendors might be able to give input if contacted early enough. Such components are not possible without a project management process. Therefore, it’s key to make the CRO part of this approach and involve them early during protocol design. Among other things, the CRO will be able to deploy resources for a fast study start and site ramp-up.