How to identify and mitigate risks to keep your timeline on track.

Biopharma companies can be an optimistic bunch – at least at the beginning of a project. When they find a molecule that shows promise, they are eager to get it to market as quickly as possible – and that can cause them to set unrealistic timelines. We all love to imagine a seamless research process where patients flock to trial sites, staff are up and running in days, and amendment protocols are unthinkable. However, in reality, drug development is rarely that easy.

For example, Tufts Center for the Study of Drug Development found that while most trials meet their enrollment goals eventually – most require twice the amount time allotted in the schedule.

When biopharma companies balance optimism with a healthy dose of realistic expectations, it can help them establish more accurate timelines, and mitigate the risks that can otherwise come from relying on deadlines that may be impossible to meet.

Hidden delays

Setting realistic timelines requires a risk mitigation assessment as part of the schedule planning process to identify the pitfalls that may slow project progress. Risks to clinical research schedules run the gamut from small, dispersed patient populations and a congested research environment, to overly-booked site staff, lack of clarity around ethics committee requirements, and high rates of non-compliance by trial participants.

Investigational Product safety and enrollment are other examples of common risks factored that can impact clinical strategy. While risk mitigation and contingency planning rely heavily on historical information and experience, solutions to these issues are largely governed by a company’s sensitivity to budget or timeline adherence.

Being aware of all the issues that can crash a schedule is the best way to prevent them from happening – though identifying them isn’t always easy. While many risks are obvious, others can be surprising. For example, we had one project delayed by an ethics committee who felt the plain black tote bags provided to patients with information about the trial could be considered coercive.

Mitigating risk: a 5 step approach

Once all of the potential hazards are identified, a cross-functional project team can define the acute and systemic options available to minimize their impact and chart the best path forward.  Development teams can follow this simple five-step mitigation flow process to define these risk response measures as part of their risk strategy:

  1. Define the probability of risk occurrence.
  2. Define the impact of the risk to cost, schedule, technical performance, and other project tasks.
  3. Determine whether it is possible to remove the risk.
  4. Define technical, financial, process and policy counter measures to mitigate risks.
  5. Implement action plans as risks occur.

It’s also important to remember that a risk plan is not static. As the project moves forward the risks it faces will change. To manage this risk evolution, the project team should reassess the risk registry periodically to identify new risks that arise, and eliminate those that are no longer a concern. Consistently surveying all available information for potential risk signaling permits early detection and resolution of unplanned issues while minimizing impact to the strategy.

Clinical research is a long and risky process, and every project faces many ups and downs before a drug can get to market. When sponsors come into this process with their eyes open, and are willing to invest the time and planning into risk mitigation strategies, they are less likely to be blindsided by events that might otherwise derail their progress.

Working with their partners to identify these risks, and having plans in place to address them if they occur is the best way to keep a project on track and your sanity in check.

Crista Casey, Executive Director of Clinical Development

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