Table 1.

Description of the 10 QDMPs.

QDMP	Description
1. Have a systematic, structured approach to aid decision making (consistent, predictable, and timely)	Establish the decision context, objectives and assumptions made. Employ frameworks, guidelines and tools for structuring the decision-making process. Such an approach should ensure that the process is systematic, which in turn would enable better consistency compared with similar past decisions, as well as predictability and timeliness.
2. Assign clear roles and responsibilities (decision makers, advisors, information providers)	The roles and responsibilities should be clearly defined in terms of individuals who provide information (including external input), compared with those who advise on the decision or make the final decision. The roles and responsibilities of each stakeholder (regulatory authorities, HTA agencies and companies) should be transparent and well communicated, which should help manage expectations.
3. Assign values and relative importance to decision criteria	The relevant criteria for the decision must be determined to ensure that these are in line with the decision context and overall objective. The criteria should be weighted, for example, by ranking or rating their relative importance.
4. Evaluate both internal and external influences/biases	Stakeholders need to be aware of personal considerations, subjective influences and biases, acknowledge them and minimize where possible. Potential biases that need to be considered (Lovallo and Sibony, 2010): ◦ Action-oriented bias: excessive optimism, overconfidence in own judgment and gut-feeling ◦ Interest-oriented bias: inappropriate attachments and misaligned incentives. ◦ Pattern recognition: generalizing based on recent events and seeking out information that supports a favored decision, which could lead to perpetuating previous mistakes. ◦ Stability bias: preference for status quo and tendency for inertia in the presence of uncertainty.
5. Examine alternative solutions	Decision makers should actively explore possible options during the decision-making process. The alternatives need to be assessed, for example using a SWOT analysis, against the relevant decision criteria in order to determine the best outcome.
6. Consider uncertainty	The extent and limitations of available information need to be judged for each decision criterion in relation to the alternative options. Stakeholders must be explicit regarding acceptability of benefits and harms and how this affects their approach.
7. Re-evaluate as new information becomes available	This should be actively carried out at all stages during the lifecycle of medicines' development. This may be a safeguard against plunging in or procrastination and/or perpetuating previous mistakes as well as identifying cultural/organizational/hierarchical influences (e.g., individual vs. organizational, group successes and group failures).
8. Perform impact analysis of the decision	The impact of the decision needs to be considered on both internal and external stakeholders. The analysis must relate to present situation, but also to the future and should take into account elements of quality/validity of data, political/financial/competitor influences and procedures for similar decisions.
9. Ensure transparency and provide a record trail	It must be clear how the decision was made and details must be consistently documented in a manner that can be easily followed or audited by appropriate stakeholders.
10. Effectively communicate the basis of the decision	The basis of the decision needs to be appropriately communicated to the relevant stakeholders, both internally and externally.