Preface

Translational Research is a highly competitive and goal-oriented field. Metrics to evaluate “translational success”, such as Time-To-Market, Likelihood of Approval (Hay et al. 2014) or Probability of Success (Wong, Siah, and Lo 2019) provide incentive structures that function as the rules of the game. As such, the choice of metric determines what learning goal may or may not be achieved by optimizing the “success” rate of Translational Research.

While economic perspectives on success metrics are important to understand Translational Research, they are limited in many respects. Clinical development is different from other business models as it critically depends on voluntary or even altruistic (Jansen 2009) research participation and hence on public trust. “Information gain per unit of accepted research burdens” is a patient-oriented concept introduced to further think about how the current regulatory oversight system learns from past clinical R&D efforts. This may serve as a starting point to think about Translational Research as a Learning System (work in progress).

The conceptualization of the scientific, institutional and economic structure of Translational Research needs to satisfy complex constraints and is challenging to fully grasp. Research ethics is often focused on particular research such as an individual clinical study. In recent times, there is increasing interest in meta-research perspectives to foster ethical organization and oversight of clinical development.

On this page, I summarize some of my readings in an unsystematic and eclectic way. The aim is not necessarily to say something entirely new or original, but perhaps someone who finds the way to this place will also find a value in the information discussed here.

Open peer-review is enabled using hypothes.is. This facilitates sentence-by-sentence annotation from readers directly on this page. Please feel free to annotate. Both constructive and destructive criticism is highly welcome.

References

Hay, Michael, David W Thomas, John L Craighead, Celia Economides, and Jesse Rosenthal. 2014. “Clinical Development Success Rates for Investigational Drugs.” Nature Biotechnology 32 (1): 40.

Jansen, Lynn A. 2009. “The Ethics of Altruism in Clinical Research.” Hastings Center Report 39 (4): 26–36.

Wong, Chi Heem, Kien Wei Siah, and Andrew W Lo. 2019. “Estimation of Clinical Trial Success Rates and Related Parameters.” Biostatistics 20 (2): 273–86.


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