Intention-to-treat

Intention-to-treat (ITT) is a principle in clinical trials where all participants are analyzed in the group to which they were randomly assigned, regardless of whether they completed the treatment. This approach preserves the benefits of randomization and prevents bias. According to ICH E9 guidelines, ITT analysis is essential for evaluating the effectiveness of an intervention in real-world scenarios. It differs from per-protocol analysis, which only includes patients who completed the treatment as planned. For enterprise risk management, ITT analysis ensures that the effectiveness of a product is assessed based on the actual treatment strategy rather than an idealized scenario, which is critical for regulatory approval and post-market risk-benefit assessments. This principle is fundamental to the integrity of clinical evidence used in pharmaceutical and medical device regulatory filings worldwide.

In pharmaceutical and medical device enterprises, ITT analysis is applied through three key steps: First, the clinical trial protocol must be designed with a clear ITT analysis plan, specifying how missing data will be handled (e.g., multiple imputation). Second, a robust Clinical Data Management System (CDMS) must be implemented to ensure all participant data, including dropouts and non-compliance, is accurately recorded in compliance with 21 CFR Part 11. Third, the risk-benefit analysis must be based on ITT results to provide a realistic assessment of the intervention's impact. For example, a drug's efficacy rating based on ITT might be lower than per-protocol analysis due to non-compliance, but it provides a more honest representation of its true value. Companies using ITT analysis as a core metric in their Quality Risk Management (QRM)--aligned frameworks can achieve up to a 40% reduction in regulatory inquiries during the pre-approval inspection phase.

Taiwan enterprises typically face three challenges: insufficient data-handling infrastructure, limited access to specialized biostatisticians, and a regulatory compliance gap. Many companies rely on manual data entry, which leads to errors in tracking patients who drop out of trials, undermining the ITT principle. To overcome this, companies should invest in validated EDC systems. Second, the lack of in-house statistical expertise can be addressed by partnering with professional Contract Research Organizations (CROs). Third, the regulatory landscape in Taiwan is closely aligned with international standards like ICH E9 and FDA/EMA guidelines; therefore, companies must proactively map their clinical data strategies to these standards. A phased approach starting with a 90-day digital transformation of clinical data processes can be highly effective, with the goal of achieving 100% compliance with ICH E9 standards within the first year of implementation.

Winners Consulting Services Co., Ltd. specializes in Intention-to-turn for Taiwan enterprises, delivering compliant management systems within 90 days. Free consultation: https://winners.com.tw/contact