Increased interest from EMA to enhance the incorporation of patients’ voices into drug development
As part of the EMA’s Regulatory Science Strategy to 2025, EMA proposes five strategic goals for human medicines regulation. Especially one of these five strategic goals emphasize an increased interest from EMA to enhance the incorporation of patients’ voices into drug development – similar to the FDA’s Patient-Focused Drug Development initiatives.
Goal 2 generally focuses on ways to provide regulators and HTAs/payers with better evidence to underpin regulatory assessment and decision-making. One of the core recommendations put forward related to this goal is to expand the benefit-risk assessment and communication – e.g. by developing ways to systematically incorporate patient-reported outcomes and patient preferences into drug development and the evaluation of benefits, harms and uncertainties. This is expected to foster patient-centred drug development and transparency about regulatory decisions.
To support the inclusion of patient preferences to inform the benefit-risk assessment, EMA intends to provide guidance on the roles of patient preferences in the different therapeutic contexts and regulatory decisions – i.e. guidance on how preferences can help regulators interpreting clinical trial outputs, how they can inform shared decision-making and how to handle heterogeneous or conflicting preferences in regulatory decisions.
Additionally, as a part of goal 2, EMA highlights that improved evidence generation also offers a chance to better capture patient preferences during the evaluation process and makes clinical development and regulation more cost-effective, potentially reducing the burden on healthcare systems.
If you want to learn more, please click here to read the strategic reflections behind the EMA’s Regulatory Science Strategy to 2025.
Next week, we will brief you on how EMA wants to strengthen the collaboration with HTAs to reinforce patient relevance in evidence generation.
Get better insights into patient preferences
One way to expand the benefit-risk assessment in drug development is to interview patients who have tested a new drug in a clinical trial. In this way, you can enhance the quality of insights into the benefits, harms and uncertainties as you can get a better understanding of how the patients experience and value the effects of your investigational drug.
Interviewing patients in clinical trials, it is important to collect and handle interview data in a systematic way as this is crucial in order to get comprehensive and representative patient input. In addition, trial patient feedback should be captured in accordance with the regulatory requirements to ensure that you can use it as additional arguments for regulators’ approval.
At Clinigma®, we are specialised in interviewing patients in clinical trials in accordance with regulatory requirements. In this way, we bring clarity and value to pharmaceutical companies by being their trial patients’ structured voice.
Click here to learn more about our services.
