NR514-NEED RESPONSES

I need help responding to the attached peers’ post in 150 words each.

Sharla Kurtz

Translational research is an approach encompassing discoveries, insights, and ideas produced by basic scientific inquiry, later used to address human ailments. It plays a vital role in research, including basic and clinical, by seeking to shift towards the bedside from the bench (Seyhan, 2019). The different aspects of translational research entail identifying targets, pathways, biomarkers, and drugs and formulating and testing human tissue xenograft and animal models. In this view, the approach has found significance when translating fundamental research outcomes by scientists into feasible applications and products. However, these intentions and acts are often challenging to the extent that translational research was labeled “the valley of death.”

The reputation of being a “valley of death,” when describing translational research originated because of the challenges encountered. Translating discoveries into effective treatments is often unsuccessful, costly, and time-consuming (Cure Search, 2020). In this case, a discovery in basic science must be guided by subsequent years of further work prior to it becoming an approved treatment. A notable instance entails the research on cancer, which has taken years to monitor how particular tumors spread and impact the human body. Worse still, it is approximated that the probability of positive outcomes involving translational research is often one percent. To put it into context, it means that out of 5,000 compounds assessed, only five will proceed with Phase I studies (Cure Search, 2020). Thus, the FDA is likely to approve just one or two drugs in the end.

Despite the recent measures to enhance the drug development process, particularly efficiency and safety, the outcomes have been mixed, coupled with high failure rates. These outcomes have been attributed to the inability to move to the therapeutic development process following scientific discoveries. In most instances, the translations are usually lost because most are irrelevant to human ailments (Seyhan, 2019). Other underlying factors further promoting such failure entail a lack of technical expertise, incentives, and funding to progress further with the practices. Ironically, despite the increment in funding for biomedical research by the National Institute of Health (NIH), there has been no rise in novel treatments and cures. Thus, most research has stagnated in the “valley of death.”

Another point to highlight is that developing and approving drugs is often extensive. Seyhan (2019) noted that the duration for a new drug took almost 13 years on average, meaning it could be even more for some drugs. When coupled with the increased costs and risks of failure, those who manage to enter the human trial face the risk of failure. According to the NIH, about 85 percent of research projects are often rejected before testing (Seyhan, 2019). From a financial perspective, it is a high number, resulting in huge losses. The field lacks enough funding and rarely attracts investors besides big pharmaceutical entities and national governments.

Overall, the assignment impacted my thoughts in a more in-depth manner concerning the subject of discussion. I got the opportunity to learn the challenges of translation research, considering that I had less insight into the manifestation of such outcomes. For example, I never understood why some projects have dragged on for more than a decade, including research on ailments, mainly cancer and HIV/AIDS. However, I learned that the process is an organic and reiterative approach requiring constant feedback involving several disciplines to guarantee success. In this regard, translational research embodies many loosely integrated practices touching on the biotech industry, pharmaceutical, and academic sectors.

References

Cure Search. (2020, November 3). What is translational research? Explaining the “Valley of Death’.” Cure Search for Children’s Cancer. https://curesearch.org/what-is-translational-research-explaining-the-valley-of-death/

Seyhan, A. A. (2019). Lost in translation: The Valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles. Translational Medicine Communications, 4(1).

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Louann Robinson

Why is translational research referred to as “the valley of death?” According to Wolfe et al. (2013), it is a “metaphorical depths to which promising science and technology too often plunge, never to emerge and reach their full potential” (p.138). When considering the academic gymnastics, funding, intellectual property issues, rules, procedures, and technology requirements, sound research and development ideas often fall by the wayside, or shall I say, “the valley of death?” (Wolfe et al., 2013).

Klitsie et al. (2019) explain the phenomenon by stating, “too often these concepts remain in the prototype stage: they are never implemented and fall into what is popularly termed the Valley of Death” (p.28).

Health care professionals and organizations need to be able to reach their diverse patient populations to advance patient outcomes effectively. According to Horvat et al. (2014), cultural competence enables providers to tailor health care needs specific to patients with diverse values, beliefs, and social, cultural, and linguistic needs.

All of this is so important because for researchers to address the needs of our underserved minority patient populations, we must first understand our audience. The best intentions and buckets full of money will not reach patients and change outcomes because the message is misunderstood. A great way to reach a minority population is to work with community leaders; this approach provides context and builds relationships and trust.

This assignment has taught me that the most effective way to improve patient care outcomes and compliance is through balancing priorities and effective communication. The patient must understand what I am saying and establish their priority goals; otherwise, what is the point? (see Appendix).

References

Hospital for Special Surgery. (2020, October 23). How to Improve Communications Among Your Healthcare Team. Retrieved May 2, 2022, from https://www.hss.edu/conditions_health-literacy-tips-improve-communication-with-healthcare-team.asp

Horvat, L., Horey, D., Romios, P., & Kis‐Rigo, J. (2014). Cultural competence education for health professionals . Cochrane Database of Systematic Reviews. 2014(5), John Wiley & Sons, LTD.

Klitsie, J. B., Price, R. A., & de Lille, C. S. H. (2019). Overcoming the Valley of Death: A Design Innovation Perspective. Design Management Journal, 14(1), 28–41. https://doi.org/10.1111/dmj.12052

Wolfe, A. K., Bjornstad, D. J., Shumpert, B. L., Wang, S. A., Lenhardt, W. C., & Campa, M. F. (2013). Insiders’ Views of the Valley of Death: Behavioral and Institutional Perspectives. BioScience, 64(2), 138–144. https://doi.org/10.1093/biosci/bit015

Appendix

Considerations between patient and provider for improved patient-centered care outcomes (HSS, 2020).

How to Improve Communications Among Your Healthcare Team

Carolyn Gaeckle

Translational research is understood to be the connection between the “bench”, or where research is actually being done, and the patient “bedside”. Translational research is the joining of research and direct patient intervention, or “that harnesses knowledge from basic scientific research into clinical research to create novel treatments and treatment options devices, medical procedures, preventions, and diagnostics essentially forming a bridge between basic research and clinical research” (Seyhan, 2019). Translational research is also sometimes referred to as “the valley of death”, and this may be for a variety of reasons. Between basic science and clinical science lies translational science, where, without proper resources and steps taken, ideas come to die. “To cross the “Valley of Death”, several key requirements must be in place to move these discoveries into new treatments, diagnostics and preventions” (Seyhan, 2019). Some of these requirements include funding and reproducibility. A study could show great promise, but if it lacks reproducibility they are going to have trouble. In addition, if they lack funding, scientists won’t have the monetary resources available to continue their research and disseminate their information. “Even with the fascinating observations and creative science, most of the basic scientific discoveries fail to get into the therapeutic development process and often get lost in translation because they are irrelevant to human disease or lack funding, incentives, and technical expertise to advance any further” (Seyhan, 2019). The process to actually move from just research to real intervention is timely, costly, and involves many different factors. Take for example a new medication that is shown to improve symptoms of a serious mental health disorder. “With an estimated cost of $1–2 billion to develop a new drug, development time lines of 15 to 20 years, and a failure rate of approximately 95%, many pharmaceutical companies have been forced to downsize their operations, especially in early drug discovery” (Gamo et al., 2017).

Gamo, N. J., Birknow, M. R., Sullivan, D., Kondo, M. A., Horiuchi, Y., Sakurai, T., Slusher, B. S., & Sawa, A. (2017). Valley of death: A proposal to build a “translational bridge” for the next generation. Neuroscience research, 115, 1–4. https://doi.org/10.1016/j.neures.2016.11.003

Seyhan, A. A. (2019). Lost in translation: the valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles. Translational Medicine Communications, Vol. 4, (18). https://doi.org/10.1186/s41231-019-0050-7

Euridice Nobre

Translational research is the transformation of basic scientific research into clinical research to develop new treatments, medical procedures, prevention, and diagnostics that improve health (Woolf, 2008). The “valley of death” is the process from basic research to clinical practice or novel therapeutics. This phase of translational research, “Valley of Death,” can be time consuming, costly, and unsuccessful at times (Meslin et al., 2013).

There are “five hills and four translational valleys from discovery to population health” (Meslin et al., 2013), i.e.,T0 basic science research explicates cellular mechanisms, their relationship to disease and identify therapeutic targets and development of treatment procedures; T1 translation to human aims to determine proof of safety, mechanism, and concept; T2 translation to patients is the tryout required for efficacy of the therapeutic agent in patients representing the relevant disease; T3 translation to practice this phase serve to enhance the therapeutic use of a therapeutic agent in clinical practice. Lastly, is the T4 translation to community, which its objective is to identify use and cost effectiveness of the medication, treatment, or prevention in relation to others currently in use (Seyhan, 2019).

In accordance with Meslin et al., (2013), moving from T0 to T4 implicates going through a diverse collection of organizations and institutional players – government, private sector, and lobbyists among them. Furthermore, challenges such as ambiguous regulation, unnecessary bureaucracy, lack of commercial incentives to innovate, and perhaps, few opportunities to revise legislation or to change habits or practices in the light of new knowledge could prevent translational science to works to its potential. Mesling et al. (2013) suggested that scientific innovation involves social and legal controversies and only “giving attention to bridging science policy’s valley of death as we do to biomedical research translational process, prospects can be favorable for the effective translation of science into collective benefit” (p.8).

This assignment impacted my thoughts on this subject as I learned that the existing gap between what is found in the lab and the actual application of evidence-based practice to helping people is associated with poor outcomes such as obesity, healthcare-acquired infections, and injurious falls (Titler, 2018). Some barriers preventing research findings from being translated into clinal practice include lack of facilities to conduct clinical research, an inadequately trained workforce, and funding (Fudge et al., 2016).

References

Fudge, N., Sadler, E., Fisher, H. R., Maher, J., Wolfe, C. D. A., & McKevitt, C. (2016). Optimizing translational research opportunities: A systematic review and narrative synthesis of basic and clinician scientists’ perspectives of factors which enable or hinder translational research. Plos One, 11(8). https://web-p-ebscohost-com.library.norwich.edu/ehost/pdfviewer/pdfviewer?vid=1&sid=831a4673-3cda-4c9c-9463-8c51aa81b4e9%40redis

Meslin, E. M., Blasimme, A., & Cambon-Thomsen, A. (2013). Mapping the translational science policy ‘valley of death’. Clinical and Translational Medicine, 2(1), 1-8. https://doi.org/10.1186/2001-1326-2-14

Seyhan, A.A. (2019). Lost in translation: the valley of death across preclinical and clinical divide – Identification of problems and overcoming obstacles. Transl Med Commun 4, 18. https://doi.org/10.1186/s41231-019-0050-7

Titler, M.G. (2018) Translation research in practice: An introduction. OJIN: The Online Journal of Issues in Nursing, 23(2). 10.3912/OJIN.Vol23No02Man01

Woolf, S. H. (2008). The meaning of translational research and why it matters. JAMA: The Journal of the American Medical Association, 299(2), 211-213. https://doi.org/10.1001/jama.2007.26