Internal validation of researcher-centered translational model: A mixed-method study

Abstract

The study aimed to examine the impact of the researcher-centered Basic Fit Translational Model and Delivery Design framework on outcomes such as visualization, progression, and self-reflection. We collected data through questionnaires, with thirty researchers participating in individual training sessions. The Wilcoxon signed-rank test’s statistically significant results (3.0–7.0) demonstrated the ease of model adaptability and the need for researcher-centered model building. The basic fit model helps researchers identify their research type, visualize shortcomings, and collaborate in an extended network, leading to successful completion. The delivery design framework helps parallel-process multiple workflows, reducing translational lag time for patients and the pharma industry.

Introduction

Translational research is a complex, cumulative, and often unpredictable process focused on moving a single or combination of basic research findings into clinical practice.[1] The average timespan of bench-to-bedside translational pharmacology research is estimated to be around seventeen years,[2] involving multidomain participation. Several translational models, such as T, process, and human-centric models, are developed to expedite research evidence to reach clinical practice. Some of the evolutionary T models are T1–T2,[3] T1–T3,[4] T1–T3,[5] and T0–T4.[6] Process models include pathways to clinical goals,[7] biomedical research translation continuum,[8] Lean and Six Sigma applications for clinical and translational research,[9] process and subprocess markers,[10] and need to knowledge model.[11] Human-centric models developed are “The Application of a Human-centered Design Approach in Health Research and Innovation”[12] and Application of Human-centered Design to Translational Research.[13] T models and process models are research-centered, whereas human-centered models are patient-centric. Irrespective of the availability of these models, the persistence of challenges around the researchers in forming Multidisciplinary Translational Research Teams (MDTRTs) and navigating through the translational process in this technology era, necessitates the need for the development and validation of researcher-centered models. To alleviate the challenges around MDTRT formation, we proposed a researcher-centered basic-fit translational model and delivery design framework, and in this study, we tested its internal validity with the pre- and post-training effects.

Overview of the Researcher-centered Model and Framework

Basic-fit translation model [Table 1]

Table 1.

Basic fit translational model

←→Observe ←→ analyze ←→ identify pattern/problem ←→ find/form a solution ←→ implement/practice ←→ test/retest ←→ observe ←→

←→Denotes thought process/stages as subprocess/translational work

Forward arrow=To spread or transform, Backward arrow=Going back in the loop/to acquire/retrace

Every term and double-sided arrow in the model represent a stage in a complete translation cycle. In particular, the double-sided arrows represent thought processes, subprocesses, and translational work. The more intricate the task and the more subprocesses there are, the more complex the project is.

Researchers can use the basic fit model to correlate their work to the stages. The researcher chooses the extent to which they will translate their work. Once they have fitted their research work – past, present, or future – into the basic fit translation model, they need to investigate how they will deliver it to the intended audience and its impact. To achieve this, the delivery design framework is helpful.

Delivery design framework [Table 2]

Table 2:

Delivery design framework

Identify the research category

Identify its place in the basic fit translational model

Identify the end users and beneficiaries

Identify the geographical boundary involving both the researcher and the end-user

Identify the type and mode of translation required

Identify the intermediaries or stakeholders involved

Estimate a timeline for a complete translation

Design a plan to execute and analyze (include processes and sub-processes)

Involve end user’s feedback and stakeholders as needed from the beginning

After translating the research results, double-check the reach and emerging difficulties

Repeat the same framework to change, adapt, and evolve

The eleven sample questions that make up the delivery design framework help researchers either analyze their prior work to determine the amount of translation or devise a new research strategy for full translation.

This is not a flow chart; it is a framework. The user can choose to work on multiple steps at once or in a jumbled manner. Users create many workflows and customize the framework to suit their needs. This approach facilitates the identification of translational en route, or navigable channels, to reach the end users and beneficiaries, as well as to determine the baseline of work stance in the translational continuum.

Methods

In the institutional translational medicine and research department, we conducted individualized training sessions for thirty multidisciplinary researchers to assess the pre- and post-effects of using the model and framework. After receiving voluntary consent to participate, we used questionnaires with both closed- and open-ended questions [Supplementary Table 1] before and after training as part of this mixed-methods approach to get both qualitative and quantitative information on the themes of visualization, progression, and self-reflection [Figure 1]. A nonparametric Wilcoxon signed-rank test was performed to analyze the pre- and post-effect scores after training after normality check.

Supplementary Table 1.

Mapping of questions to core concepts

Quantitative questions	Related qualitative questions	Base concept
Are you aware of the word translation	Define the term “Translation” in your own words	Definition
Do you have prior knowledge about dissemination of results?	Upon completing your research, what is your typical process for disseminating the findings to the intended audience?	Prior knowledge
Do you concur that the dissemination of findings to the end user is a crucial aspect of research?	What is the significance of reaching the end user once the regulatory procedure has been completed to validate the findings?	Importance
Do you have a clarity in the orderly approach of distributing the results of research findings?	Briefly state some of the steps involved in this approach	Clarity
Could you provide a comprehensive outline of the method by which results are distributed to the intended user?	Provide example of one such map in detail	Overview
Are you aware of your stance as a researcher and your role in the whole process of disseminating result?	Please provide a concise description of your current position and role	Work zone
Are you aware of the next necessary step to be taken to completely disseminate results to the targeted audience?	Explain one important step involved in detail	Next step
Considering the time taken to complete dissemination of results, do you think if has affected yourself as a researcher	Explain in detail regarding the self-impact	Self-impact
Do you believe that fully disseminating the results to the intended audience will contribute to societal value?	Outline in brief about the social impact	Social impact
Do you concur that it is crucial to prioritize keeping track of the physical, mental, and emotional well-being of a researcher when completing an entire dissemination?	Comment on long-term emotional well-being	Long-term emotional wellness

Figure 1.

Outcome variable themes

Results

A Wilcoxon signed–rank test showed that the individualized training elicited a statistically significant change in researchers’ overall knowledge about translational research and the importance of MDTRTs to achieve complete translations (z = −4.916, P = 0.000001). The median effect scores increased from 3.0 to 7.0 between pre- and post-training.

Discussion

The nature of the traditional blending of translational science and pharmacology has been evident since the inception of the concept of “translation.” T1–T4 involves the translation of basic research to humans, followed by its application in clinical settings, practice, and the population, with the ultimate goal of improving public health.[6] Translational T and process models, developed over decades, focus on research and clinical usage to improve individual patients’ benefits. The application of human-centered design models to enhance research and innovation marks the latest milestone achieved.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 Guideline provides general principles for planning and designing Multi-regional Clinical Trials (MRCT).[14] In alignment with ICH E17 principles, translational research and quantitative clinical pharmacology tools are highlighted as core enablers for Asia-inclusive global drug development.[15] MRCTs require enormous inbound translational pharmacologists to be part of research teams, necessitating knowledge dissemination to promote clarity of the role. This substantiates the need to challenge the status quo and shift the paradigm from research-centric to researcher-centric models. A complete translation requires the involvement of multidomain experts. In this data-driven era, MDTRTs are the key to solving complex problems, and we must explore all efforts to decrease the translational duration of clinical trial outputs.

In this process of exploration, we proposed a researcher-centered basic fit translational model and delivery design framework. In the traditional approach, the focus is on research, and the translation process is valued in stages. Moving from one stage to another is seen as progress. On the other hand, in the researcher-centric model, the researcher is recognized and given credit for their contributions to the translation process. We test the internal validity of the proposed framework usage during pre- and post-training sessions, comparing it to the outcome measures of visualization, progression, and self-reflection.

Researchers underwent visualization tests to assess their understanding of the word “translation,” their prior knowledge of translational work and its continuum, the significance of a comprehensive translation, and the clarity of their comprehension of the overall translation process. The progression involves testing an overview of the steps involved in completing one translational cycle, identifying the current work zone in the translational process, and generating ideas about the next needed step. Upon considering the duration and complexity of one complete translational process, we test self-reflection to understand the researcher’s viewpoint on self-impact and social impact in attaining complete translations. Finally, we test long-term emotional wellness, which includes adaptability, vulnerability, and resilience.

All the participants strongly held the viewpoint of social impact; they considered it one of their personal achievement goals and correlated it with their emotional well-being. Though they do not have a complete knowledge of total translation, they do recognize a few steps to reach the goal of making a social impact. Training has improved their comprehension of the translational continuum and helped them identify their current work on it. However, each participant’s next immediate step and progress varied, and many struggled to pinpoint the sequence of steps they needed to take. In such cases, existing institution-based translational teams, such as those from the department of clinical trials, translational research, and innovation incubation centers, can guide them through the collaborative needs and affirm their pathway to ease the translational process.

Though the time taken between the individual researchers varied in understanding the model and framework, and to apply it, they easily grasped the concept behind and the process involved with individual training. The statistically significant results of nonparametric Wilcoxon signed-rank test showed that the median score is improved posttraining session, replicating the ease of model usage.

Overall, the basic fit model assists researchers in identifying their research type in the T model continuum, visualizing the shortcomings and collaboration opportunities in an extended network, and leading ways for successful completion. The delivery design framework enables researchers to parallel-process multiple workflows, reducing translational lag time in bringing benefits to patients as well as the pharma industry.

Conclusion

Statistically significant results showed the ease of model adaptability and the need for researcher-centered model building. The shift of translational models from research-centered to researcher-centered has provided preliminary proof of MDTRT’s formation success. This researcher-centered model, combined with the research- and patient-centered translational model, will aid in complete translations. The model and framework will undergo constant validation to ensure its accuracy and reliability. Further validation methods will include testing for both temporal and external validation.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.