Insights

# Tackling Risks Related to Unforeseen Project Costs

June 7, 2021

It is recognized in the industry that unforeseen project costs can jeopardise a clinical trial’s continuity and progress: according to a 2016 study, up to 22% of failed phase 3 studies listed economic concerns as one of the factors that led to suspending the trial.$$^1$$

It is, however, safe to assume that a study that has reached phase 3 would have never begun without apparent sufficient funds. Still, any additional costs that were not foreseen in the initial stages of the trial can reappear after the trial has already started. The key to preventing them is to identify where extra expenses may arise, prepare ahead for them, and allow for flexible allocations that permit the project to get back on track.

## Sources of Unforeseen Expenses

Although they may appear surprising, extra expenses are rarely spontaneous. Furthermore, they can often be traced back to certain mismanagement problems.

One of the most important factors behind unforeseen costs is communication issues between the CRO and Sponsor. Assumptions or lack of clarity between both parties can result in issues of different kinds, such as a poorly-defined scope of work or unrealistic expectations by the sponsor. In turn, this may prevent either from implementing proper contingency plans.

Other common sources of unforeseen costs may emerge due to the following problems:

• Insufficient understanding of local characteristics. This may relate to area requirements, legislation, and healthcare systems at the country, region, or local level. It often causes gaps in planning and risk assessment.
• Missed enrollment targets. Without a representative sample, a study will not be able to continue. Therefore, if adequate enrollment targets are not initially reached, it will be necessary to redesign the patient recruitment strategies. This may involve offering new incentives or even to include additional sites or countries.
• Logistic issues. Any equipment or trial materials that were not originally deemed necessary will bring about additional expenses, such as transport, importation, custom fees, and storage costs. This includes the provision of any completely new trial materials, as well as replacing any that expired or were damaged during transport.
• Trial protocol adjustments. Most protocol adjustments will require documents to be updated, and additional submissions to regulatory bodies. Changes involving trial duration will be particularly impactful.
• CRO and site staffing issues. Changes in CRO and on-site staff after the trial has started will require additional training and onboarding, increase the hours billed for project or site management, among others. High turnover ratios, even in non-supervisory positions, can also affect overall productivity and potentially cause delays.

Any of these problems will directly generate additional costs, but they are also very likely to cause missed deadlines. Trial delays, due to any reason, could then lead to additional project or site management hours, further changes in enrollment, or additional document submissions.

## How to Avoid Unforeseen Project Costs: What Needs To Be Done?

It should be noted that many of the issues described above are closely linked with each other. This is why proper planning and risk assessment should be in place at the very beginning.

At the planning stage, best practices should include the modelling of potential scenarios. The impact of each scenario should be followed through to its conclusion, and provisions to meet these costs should be included.

When possible, cost-control measures should be included, or just taken into consideration. These may include enrollment mitigation plans to be implemented to counteract potential enrollment limitations.

Finally, it’s useful to be aware of the local regulatory requirements affecting the countries where the study will be held. This may help to better assess possible timelines, and the required speed of enrollment. Knowledge of the financial environment will help predict changes in taxes, the labour market, salary trends, or possible logistic issues. This will permit the CRO to draft better mitigation plans.

## How Can Dokumeds’ Experience Help Your Cost Predictions?

The process should begin with proper planning and risk assessment, as well as local know-how. As a Clinical Research Organization, Dokumeds has gained 25-years’ experience in conducting clinical trials.

Dokumeds’ approach is to evaluate any potential financial risks from the moment we start preparing initial proposals. We then continue to monitor these risks throughout the course of the cooperation. Dokumeds’ expertise and knowledge of local specifics, along with risk evaluation and thorough financial modelling has helped our clients reduce the number of change of scopes to an absolute minimum.

When involved from the feasibility stage, Dokumeds can help sponsors identify and select the right sites required for successful enrollment. Through close collaboration with local vendors and key opinion leaders, we are also able to prevent delays or mistakes in the course of the study and to recognize potential regulatory bottlenecks ahead of time.

One of Dokumeds’ important objectives is to understand our Sponsor’s expectations and needs. Our qualified and experienced team can provide guidance in local procedures and requirements, and therefore prepare professional and thorough budgets, ensuring best trial results.

References:

1. Hwang, T. J., Carpenter, D., Lauffenburger, J. C., Wang, B., Franklin, J. M., & Kesselheim, A. S. (2016). Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA internal medicine, 176(12), 1826–1833. https://doi.org/10.1001/jamainternmed.2016.6008
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