Time lags in the translation of medical research: Developing a case study approach to achieve a better understanding

A major challenge in medical research is how best to ensure that research findings are effectively translated from 'bench to bedside', and are put into practice to benefit patients. Research suggests that at present in the UK it typically takes 17 years for new discoveries to be put into practice. But this estimate is not clearly defined and the difference in the time taken to translate research between different types of intervention (e.g. a new drug compared to a new surgical procedure) is not well established. The sources of these delays in translation, or 'time lags', are also unclear, as is whether they are always undesirable. It is, for example, important that new drugs are tested for safety before being put into general use.

As the number of models of translation gaps multiplies (and the definitions of such gaps increases), it becomes increasingly difficult to make comparisons between different studies and advance the field of study. Our project would provide a way to facilitate such comparisons.

The aim of our project is to develop a new approach to thinking about these time lags, incorporating a process marker model, which is a method that tracks the time taken between different milestones in the translation of research into practice. Our new case study approach should allow us to understand more clearly the sources of time lags, whether they are undesirable or not, and whether they differ between types of medical intervention. Our analysis of timelines in examples of research being translated into practice will also explore the perspectives of a range of stakeholders including the private sector, which is often inadequately incorporated into such academic studies, and a full range of issues in the complex pathways from early research to successful implementation in healthcare.

We will trial the method with a small number of examples in cardiovascular and mental health research. If the method proves effective, we hope to then extend the study and conduct a fuller analysis of time lags across the health research system.

The issue of attempting to reduce time lags and speed up the translational process is receiving considerable attention and investment from policymakers in countries such as the UK and the USA. It is our premise that we need improved methods to analyse the problems, and measure the extent of the time lags, before the most effective policies can be found. To help understand the processes more fully and inform any policy recommendations that seem appropriate we also propose to conduct a documentary analysis of the existing policy initiatives.

Ultimately, if we can clearly identify the sources of time lags, and where they could be influenced by policy, we hope our study will allow the translation of research to become quicker, meaning patients benefit more quickly from new research developments, improving the effectiveness and efficiency of patient care. Furthermore, it could eventually be of considerable benefit to pharmaceutical and medical device companies who are keen to explore ways in which research could safely be translated more rapidly into products purchased and used by healthcare systems. Specifically in relation to the economic competitiveness of the UK it is of considerable advantage to the UK to be seen as a country in which the academic research community can collaborate efficiently with pharmaceutical and medical device companies.

Finally, attempts to measure the return on investment in medical research need to incorporate an analysis of the time it takes for the research to be translated. If we can develop an improved way of analysing time gaps, and develop a more reliable figure for the length of the time lags, then that would make a major contribution to measuring the links between research and economic impacts and strengthening the estimates made of the value of UK medical research.

This project uses a case study approach to investigate time lags in the translation of medical research. Existing models of research translation typically refer to the concept of a translation 'gap', but how these gaps are defined differs between approaches and can lead to results not being comparable. We propose to use the process marker model proposed by Trochim et al (2011) as the basis for our case study approach. Here, specific research translation milestones are considered to be process markers and are clearly defined to enable comparability between the various examples of translation (and the diverse models currently used to describe them). Time lags can then be assessed relative to these markers.

A key element of this project is to develop and trial this approach as a basis for case studies to investigate time lags. We plan to conduct six pilot case studies in the fields of cardiovascular and mental health research. We will conduct both backward and forward tracing case studies, and in particular intend to cover a range of types of intervention (e.g. new drug, surgical procedure, medical device, screening programme) as we believe the translation pathways, and hence both the markers and the primary sources of time lags, are likely to differ between types of intervention. This study will also provide an initial test of the applicability of the process marker model.

If the method proves successful, we hope to conduct further case studies using the approach allowing us to produce a more in-depth analysis of the sources of time lags, which ones are desirable or undesirable (a delay in translation to ensure the safety of a new drug, for example, may well be desirable), and how they differ between types of intervention. This will allow us to develop policy-relevant recommendations; building on this we hope to produce on the basis of the findings of the pilot project.

Who will benefit from this research?
A wide range of organisations could benefit from the findings of this study, and the follow-up study to which it might lead. It is important to stress that many of the eventual potential benefits would inevitably take a long time to achieve, but some of the policy changes that might bring about these eventual benefits could themselves be introduced relatively quickly.

Improving ways of analysing time lags so as to better inform policies to reduce translation times is relevant to aspects of the whole health research enterprise, the use of such research in healthcare systems and the commercial exploitation of such research. There are, therefore, many stakeholders groups for whom this study has a potential benefit.

Private sector organisations that might benefit include the pharmaceutical and medical devices industries, for which finding safe ways to reduce the time taken to translate research into products and for those products to be adopted in the healthcare system, is of central importance.

Similarly any organisation that funds or conducts medical research would benefit if evaluation of the research translation process is improved so that policy-makers, managers and researchers are better informed about where there are delays that could potentially be tackled. This applies both to public sector research funding organisations and to the charitable sector. The diverse list of research funding organisations attending the MRC Workshop in November 2011, Measuring the Link Between Research and Economic Impact, illustrates the range of bodies interested in issues around increasing the benefits from medical research. Many research funding organisations in other countries and international bodies would also potentially benefit from this research that addresses an issue that potentially faces all countries.

Policy-makers in healthcare systems and organisations, including those in regulatory bodies, will also all benefit if greater clarity can be provided about the whole translation process and the interventions that might be desirable safely to speed up the translation process.

Members of the public as patients and carers would benefit eventually if the improved methods of analysing the translation process led to the identification of policies and practices to reduce time lags, and this in turn resulted in beneficial therapies being introduced more rapidly into healthcare systems.

How will these people and organisations benefit from this research?
Pharmaceutical and medical device companies would benefit commercially if time lags in the translation of research into healthcare practice could be reduced. This would apply in the UK and elsewhere, but given the study is being conducted in the UK any eventual policy recommendations are likely to be particularly relevant for the UK. These developments would help to foster global economic performance, but especially the economic competitiveness of the UK. Identification of ways in which greater collaboration between a pharmaceutical companies and academics might reduce time lags could be beneficial for both companies and higher education institutions.

Organisations that conduct and fund research would benefit if the research led eventually to better policies that made the processes more efficient and there was a reduction in time lags between the research findings being produced and the eventual improvements in healthcare. This would help them achieve their mission and also improve their ability to show that the money they receive (from taxation or donations) is a worthwhile investment.

Similarly, healthcare organisations and patients would directly benefit if the study eventually led to policies that speeded up the translation processes and resulted in healthcare improvements.