Drug development costs are higher and timelines longer than they have ever been. Study protocols are complicated by factors
including the complexity of international markets, which have unique regulatory requirements and economic conditions. Still,
researchers must assure that clinical trial planning and execution proceed effectively and efficiently.
Organizations can better decide whether to launch a product or terminate its development by bringing together their best data
and best minds with best practices.
Many pharmaceutical companies apply three basic principles for improved clinical trial-based decisions. These decisions range
from clinical development plans for a given indication—making sure the right questions are asked and answered—to which indication
to investigate first, to which CRO should carry out the study. Three decision principles can reduce risk and increase the
probability of drug development success:
Collaborative prioritization. When scientists, physicians, quality assurance, compliance, marketing, and operations stakeholders make decisions together,
their objectives compete. Some are based on structural incentives of their role, others by individual preferences/biases.
All are shaped by good, but often incomplete, information. Decision makers must collaborate to structure their decisions.
With a framework for choices, stakeholders can collectively weigh in on the relative importance of factors, gain insight into
the positions of others, and highlight and diffuse biases to reduce knowledge gaps.
Using techniques like paired comparisons of criteria, stakeholders can draw out points of agreement and disagreement and better
learn what drives their choices. This fosters fair process, consensus building, and common language, and disarms advocacy-based
decisions by framing issues important to the choice. Performance of options can be clearly tied to key factors, and objectives
and priorities can be linked to courses of action.
Sensitivity analysis. Decisions rarely remain static for long. Considerations change as new evidence is collected. Financial considerations before
and after an economic crisis, or regulatory considerations on either side of an election or court ruling, can be very different.
The performance of options against key criteria can be independent of the importance of criteria. With the collaborative prioritization
described above, relative importance of criteria can be adjusted to reflect actual or hypothetical future scenarios. Testing
decisions this way, stakeholders can understand how fragile or robust their choices are and ask questions.
Decision mapping. A repository of prioritized factors from previous decisions allows you to see how a decision was taken. A decision map can
compare the future outcome of the decision to the usefulness of the framework used to make the choice.
Mapping lets decision makers assess the accuracy of their predictions, and how well factors were understood. Mapping also
helps improve decisions over time. Stakeholders can observe whether perceived success factors were truly influential, better
understanding the factors that affected the decision—and alternate courses of action if those factors had been anticipated.
They can also begin to understand the value of their estimates or forecast of performance against key decision criteria.
By applying these practices in a structured decision making framework, pharmaceutical decision makers can increase collaboration,
transparency, efficiency, and effectiveness in clinical research decisions, while reducing development risks.
Kevin Connor Executive Vice President of the Decision Solutions Group Decision Lens E-mail: firstname.lastname@example.org