Bringing new products to market in the era of outsourced clinical trials is reliant on the ability of sponsors and CROs to work together.
The increasing globalisation of R&D has led to a rise in clinical outsourcing, as pharmaceutical companies find it difficult to operate solely with in-house teams.
A recent report by Research and Markets predicts that, by 2020, 72% of clinical trials will be outsourced to contract research organisations (CROs)1, up from just 23% in 2012.2
This is a great way to reduce operational and infrastructure costs, increase clinical timelines and organisational agility, and achieve scalable growth. If done well, CROs have the potential to deliver savings in both time and money, increase patient safety, improve regulatory compliance, and enhance trial data quality.3
But all this is reliant on a collaborative, effective relationship between sponsors and CROs. It must be based on trust and involve transparent communication. This is not necessarily easy to create.
A sponsor’s involvement in highly specialised clinical trials, and the need for multiple CRO partners to manage large pipelines, inevitably results in a complex operating environment.
Sponsors are generally seeking to reduce costs, access specialist knowledge, decrease clinical timelines and adapt quickly. CROs, on the other hand, need partnerships with multiple sponsors to remain economically viable, focusing on business goals related to economic success for their owners, investors and shareholders. These differing goals, processes and culture, can make it a challenge to create an effective collaborative environment.
Although some sponsors have taken positive steps, many still perpetuate a client/vendor mentality at both the operational and management levels. This tends to perpetuate a lack of trust in, and reduces the empowerment of, CROs, ultimately leading to frustration for both parties. This results in inefficiencies and needless duplication of tasks.4
Collaboration means shared decision making, delivery of broad cross-study solutions, performance assessments, and shared risk and reward structures. The goal is for the partners to operate as a team where both parties benefit.
Tips for successful collaboration
- Learn each other’s language and culture. Increasing globalisation necessitates both sponsor and CRO to perform due diligence in learning each other’s ‘language’ and culture in order to foster collaboration and trust.
- Establish joint, multi-level governance of study activities.2,3 Collaboratively establish a common vision and understanding of the partnership. Develop goals and metrics that measure alignment with, and performance against, the shared vision of both partners.
- Establish a mutually agreed practical communication plan.3 To avoid communication breakdown, have a centralised and practical communication plan that includes escalation procedures on both sides at all levels. Define what kind of communication is expected during the study, and what event(s) trigger an escalation.
- Develop and maintain a study/site risk assessment plan.5 Sponsors and CROs should work together to identify potential risks and design risk mitigation actions in advance wherever possible. Ongoing risk assessments should be performed on the site and the study itself to assure data quality and prevent problems.
- Define business processes, including roles and responsibilities.3 Both study sponsor and CRO have defined business process and systems in place for elements of the study lifecycle, and both will need to adapt to form an effective partnership. Make sure everyone on both teams understands the overall study processes and the role of each person.
- Establish key performance indicators (KPIs) for partners and study deliverables.3,6 In order to be meaningful and effective, KPIs need to be created collaboratively and align with incentives for both partners. Team members from both sponsor and CRO must understand how study progress is being measured and why.
- Determine how KPIs will be monitored and addressed when deficient.3 What is the level of transparency and accessibility needed to effectively monitor KPIs, and what is the team going to do if there is a problem?
- Align team goals with business goals across the partnership.3 The business objectives of both the sponsor and CRO need to be taken into account when defining team goals.
- Invest in software tools that enable communication, management, and automation of activities.2 Cloud-based platforms that enable immediate data sharing across partners are ideal for this.
- Treat study team members as one cohesive unit, regardless of the organisation.3,4 Give CRO partners a say in things like protocol design, the monitoring plan, and data management practices. Develop incentives to motivate team members to support both the short-term study and the long-term partnership expectations.
- Create an atmosphere of positive collaboration and continuous improvement.3 Effective collaboration requires transparency. Put in place mechanisms to enable two-way communication and feedback between CROs and sponsors to ensure the success of the study.
Successfully bringing new products to market in the era of outsourcing clinical trials rests, to a large extent, on the ability of sponsors and CROs to work together. This partnership must operate with open and transparent communications that foster a foundation of trust and mutual commitment.
The process is only one aspect to consider, however. Of equal importance is implementing the right technological tools to support process transparency, data sharing, and communications across company lines. This will, ultimately, speed the delivery of life-saving therapies to patients and disrupt the client/vendor ‘status-quo’ mindset.