Arrow Translation’s Role in ClinRO Assessment: New Challenges in Global Clinical Research

As the global clinical research field faces increasingly complex clinical trial requirements in 2025, many studies face higher challenges, especially in ClinRO (Clinician Reported Outcome) assessments. ClinROs are a type of clinical outcome assessment tool (COAs) that mainly measure the health status of patients to help scientists better understand how patients feel, function and survive, and provide reliable endpoints for evaluating the effectiveness of treatment. These assessments are usually performed by specially trained medical professionals, and professional training is essential in assessing the health status of patients.

According to the ISPOR COA Good Practice (GP) Task Force Report updated in 2025, an increasing number of new drug applications (NDAs) have failed FDA approval due to lack of clear clinical endpoints or inconsistency between multiple study endpoints. In the past five years, more than a quarter of new drug applications were rejected at first review, of which 13.2% were rejected due to vague evaluation criteria and another 13.2% were rejected due to lack of endpoint consistency. This trend highlights the importance of adopting good measurement practices and the key role of rationally developed outcome assessment tools in improving the efficiency and accuracy of clinical trials.

The important role of Arrow Translation in ClinRO evaluation

Good measurement practices are an important tool in ClinRO evaluation development, and Arrow Translation plays a core role in global multilingual clinical trials. With its rich resources and professional team, Arrow Translation is able to ensure that the translation of different language versions is consistent with the original concept, thereby ensuring the consistency of evaluation tools around the world, thereby improving data quality and the effectiveness of clinical trials.

How Arrow Translation helps clinical research

In the early stages of clinical trials, Arrow Translation works closely with healthcare professionals to ensure a comprehensive understanding of how patients feel, function, or survive during treatment through concept-guided interviews, focus group discussions, and other research methods. These activities help identify key areas to ensure that assessment tools accurately reflect treatment benefits.

Ensure content validity

In multinational clinical trials, it is crucial to ensure that the translated version is conceptually consistent with the source document. Arrow Translation verifies the validity of the translation through cognitive interviews or clinical reviews by experts in the relevant therapeutic areas to ensure that it meets clinical needs. At the same time, considering the differences in clinical practices in different regions, our translation and language verification team will ensure that the translation meets the professional requirements of each region.

Arrow Translation’s role in standardization training and operations

During the implementation of clinical trials, Arrow Translation provides multilingual training support and helps write operating manuals, scoring standards, and consistency documents. Our life science and language validation teams integrate global resources to ensure that these technical documents can be effectively applied in different countries and regions. Through this cooperation, we not only help ClinRO evaluate good measurement practices, but also improve the FDA's approval rate for new drug applications.

ISPOR Good Measurement Practice Checklist Supported by Arrow Translation

1. Identify usage scenarios
2. Select the expected treatment benefit
3. Determine the concept of evaluation
4. Assessing the relationship between treatment benefit and concept
5. Ensure content validity
6. Evaluating other measurement properties
7. ClinRO in defining endpoints/goals
8. Interpretability of results
9. Operational considerations for implementation

The report emphasizes that when trial objectives do not fully integrate the views of patients, clinicians, regulators, and payers, trial objectives may not align with actual needs, making trial results difficult to interpret. Therefore, it is very important to ensure that feedback from all parties is collected when defining endpoints.

Arrow Translations provides multilingual documentation support, professional clinical review, and global researcher training to ensure that ClinRO evaluations effectively reflect treatment effects in clinical trials, providing important support for the drug approval process. We not only provide language services, but also provide vital support for the success of drug development and clinical research.

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