Lost to translation: The gap between scientific discovery and clinical practice
The translation of scientific discoveries in health and medical research brings evidence to the forefront of clinical practice. Research translation improves patient care by ensuring that the best available evidence is used in practice. It can also help to restrain health care costs.
Australia (and the world) continues to enjoy an explosion of scientific discovery in health and medical research, but the translation of these findings into clinical practice is often elusive – even referred to as ‘the valley of death’. As a result, money, knowledge and potential health benefits are lost to translation.
In this edition of In Brief, we explore the concept of translational research, roadblocks in the translational process and potential solutions for bridging the gap.
Defining translational research
Translational research is a relatively new term that has evolved from the increasing need to facilitate translation of evidence into clinical practice, policy, guidelines and further research, as well as population outcomes more broadly. Translational research is not clearly defined in the literature. It is commonly described as the process of transforming basic research findings into clinical applications – and ultimately into public health improvements.
Basic and applied research
The objective of basic research – sometimes referred to as ‘basic science’ – is the acquisition of knowledge. This kind of research is not obliged to apply its findings to practical ends, and thus does not typically lead to widespread implementation into clinical practice.
On the other hand, as the term suggests, applied research (sometimes called ‘clinical research’) typically seeks to answer a specific research question whose findings have direct application.
Findings from basic research are often used to inform the design of applied research, and conversely from applied research are often used to test hypotheses in basic science. This interplay between basic research and applied research is sometimes referred to as ‘bench to bedside’ – a term commonly associated with translational research.
The National Institutes of Health (NIH) define translational research as:
(1) The process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans; and
(2) Research aimed at enhancing the adoption of best practices in the community.
Rubio and colleagues formulated a more detailed definition:
Translational research fosters the multi-directional and multidisciplinary integration of basic research, patient-oriented research and population-based research with the long-term aim of improving the health of the public.
A growing divide between research findings and clinical application
The 20th century was witness to an explosion in scientific knowledge, and this trend has continued into the 21st century. In 2014, approximately 2.5 million scientific articles were published across 28 100 peer-reviewed scholarly journals in English. At the same time, this burgeoning scientific knowledge remains underutilised in the clinical setting and across health systems.
The 2012 CareTrack study highlighted the growing divide between the findings of research and clinical application. In a sample of 1154 Australian adults, 43 per cent did not receive health care that was appropriate or based on evidence.
In the same year, Elshaug and colleagues reviewed the scientific literature and identified 156 potentially ineffective or unsafe medical practices being utilised in Australia’s Medicare Benefits Schedule (not including pharmaceuticals).
Bridging the gap
In order to accelerate and promote research translation it is necessary to consider a continuum, starting from basic scientific research to public health improvements.
Consider the eradication of poliomyelitis (polio). In 1953, medical researcher Dr Jonas Salk successfully tested a vaccine that would eventually lead to the widespread eradication of polio. While this is a somewhat simplified example, when applying the continuum, however, it’s clear that several major efforts drove Salk’s discovery from laboratory discovery to eradication of disease, including:
- Clinical trials of the polio vaccine, undertaken in 1954 across the United States: 623 972 school children were injected with the vaccine or placebo. More than a million others participated as observed controls
- Mass production of inactivated poliomyelitis vaccine (IPV)
- Development of an oral vaccine. In 1962, researcher Albert Sabin developed an oral polio vaccine (OPV), greatly facilitating the distribution of the vaccine
- Registration of OPV after trials in Tasmania
- Introduction and funding of a national vaccination schedule
- Continuing development of vaccination recommendations and schedule. Currently, in Australia, it is recommended that children receive doses of IPV at 2, 4 and 6 months of age, followed by a booster at 4 years of age
- National coordination of various sectors to meet requirements for Australia to be declared polio free.
NIH Research Translation Framework
The NIH provides a comprehensive framework for understanding the continuum from scientific discovery to population health outcomes. The framework consists of four main phases and emphasises the iterative (or circular) process of research translation.
The 2013 McKeon Strategic Review of Health and Medical Research summarised this framework as follows (see figure 1):
- T1 – from discovery research to health applications (test, interventions)
- T2 – from health application to evidence guidelines
- T3 – from guidelines to health practice
- T4 – from health practice to population health outcomes.
Figure 1: NIH research translation framework
Adoption by an organisation of a framework that conceptualises research translation as an iterative process is seen as promoting a collaborative research environment. A research translation framework also provides a standardised language for communication and dissemination of research – a lack of which has been cited as a major barrier to translation. Standardised language has the potential to foster development of appropriate criteria for measuring the success of translational research projects, so as to ensure rigour and avoid complacency. Conversely, a lack of standardised language makes it difficult for translational research programs to develop specific program objectives and competencies, and to track outcomes.
In the 1960s, when medical research was largely conducted by physician–scientists who also treated patients, the links between scientific discovery and clinical practice were strong. Today, research and clinical practice tend to operate in silos, a development that has contributed to the growing divide between scientific discovery and clinical practice.
In a 2012 keynote address about funding for Australian research, Australia’s Chief Scientist, Professor Ian Chubb, argued that for translational research to be fully effective in Australia, cultural change is needed. Culture needs to cut across the silos of government-funded research institutes, the academy, hospitals and health care research to bridge the divide. Indeed, the overarching message from the Strategic Review of Health and Medical Research by McKeon and colleagues in 2013 was the need to forge stronger connections between health and medical research and the delivery of health care.
Health services research
There is no doubt that health care organisations have a significant role to play in bridging the divide between the findings of research and clinical practice. Beckett and colleagues identified a number of approaches that can be employed to encourage clinicians to participate in research. These include development of an outreach program to promote the benefits of research, selecting study topics that are of interest to clinicians and relevant to their patients, development of schedules for reimbursement for research tasks undertaken, provision of technology and technical assistance and promotion of a sense of community among clinicians engaged in research.
In a 2016 systematic review, Fudge and colleagues described the factors that enable or hinder research translation as largely shaped by wider social, organisational and structural factors, rather than individuals. For example, research indicates that nurses in Australia are supportive of evidence-based practice but rate their knowledge and skill to implement it as low to moderate.
Bornstein and Licino argued that the pressure to publish in high-profile journals is discordant with a successful translational process. Research translation is both time and resource consuming, and the pressure on researchers to focus on publication to maintain funding support and professional advancement reduces their capacity to contribute to the implementation of their research findings. Ioannidis proposed a potential solution involving appraisal of the clinical utility of research papers published in journals.
The struggle and stress to secure funding is also not conducive to the type of creative thinking that lends itself to leading-edge science and innovative studies that may be considered ‘risky’ are often not rewarded by the peer review system.
Szaszi suggested that support provided by organisations could increase funding security and decrease the reliance of researchers on the grants system.
Support for research translation
The NHMRC has implemented a number of measures to support rapid and effective research translation,
including recognition for Advanced Health Research and Translation Centres (AHRTCs) and Centres for Innovation in Regional Health (CIRH), and through its annual funding schemes and guidelines.
Academic health science centres (AHSCs) such as Western Alliance are formal partnerships between universities, health care providers and other key stakeholders to foster collaboration in research, clinical services, education and training.
Western Alliance works to ensure that research evidence is translated into clinical practice, policy, administrative decision making and benefits for patients and communities. Each year, Western Alliance supports the development of collaborative, applied and translational research to improve health outcomes for people in the western Victorian region, through its Research and People Support Program, including the annual Grants-in-Aid. Click here for a list of research supported by Western Alliance since 2015.