Protein Biomarker Research in UK Hospital Clinical Biochemistry Laboratories: A Survey of Current Practice and Views

Abstract

Background: With the increasing drive for more and better disease biomarkers to underpin the stratified or personalised medicine agenda, clinical biochemistry laboratories should be ideally placed to play a major role in their translation into clinical practice. However, little is known about the current extent of biomarker-related research activity in UK National Health Service clinical biochemistry departments.

Methods: In December 2010, an online questionnaire was sent to active UK members of the Association for Clinical Biochemistry (ACB) to determine the extent of their current research activity and involvement in protein biomarker discovery and translation, including an assessment of the awareness of proteomics.

Results: A total of 198 eligible responses (19% response rate) was received from across the UK. Of a further 50 eligible people who responded to a follow-up for initial non-responders, most cited insufficient knowledge about the topic as the reason for non-response (24% total response rate). The results illustrate the highly skilled nature of the workforce with many having experience in a research environment (75%) with postgraduate qualifications. However, more than half spend <10% of their time undertaking research in their current role, and many (61%) would like to be more research active. Encouragingly, approximately a third were involved in biomarker discovery activities, even though for <10% of their time, with slightly more reporting involvement in biomarker translation.

Conclusions: Although there are people with the necessary skills and desire to be involved in biomarker research in clinical biochemistry departments, their involvement is small, predominantly due to issues with capacity and resources. It is likely that the majority of biomarker programmes will therefore continue to be carried out by a small number of academic groups, hopefully with collaborative input from hospital laboratories.

Figure 1.

The biomarker pipeline. Following the selection of suitable clinical samples to answer a clinical question, the biomarker discovery stage begins. This can include some of the ‘omic’ technologies and usually multiple platforms are used. Candidate biomarkers are then chosen for their novelty and relevance and validated by independent methods such as antibody arrays, multiple reaction monitoring or ELISA. This follows with the development and validation of biomarker assays and qualification of the biomarker for its intended clinical endpoint. The clinical evaluation phase includes clinical trials prior to translation into clinical practice. Throughout the pipeline the number of samples required for testing increases and the number of biomarkers in the pipeline decreases.

Figure 2.

Experience. Period of time (years) respondents have worked in a diagnostic laboratory (dark shading) versus years in a research laboratory during previous employment (light shading).

Figure 3.

Roles and research time. (a) The role of clinical biochemistry currently (dark shading) and what the future role of clinical biochemistry should be (light shading). Since respondents could choose any number of statements the data is shown as percentage of respondents who selected each possibility. (b) Percentage time spent on research in current position.

Figure 4.

Experience of proteomic techniques. (a) In a diagnostic laboratory (b) In previous research employment. Respondents who had never worked in a research laboratory are excluded in the calculation of % respondents in (b). Key: 1D-GE = 1D-gel electrophoresis; 2D-GE = 2D-gel electrophoresis; TMS = tandem mass spectrometry; MRM = multiple reaction monitoring; MALDI = matrix-assisted laser desorption/ionisation mass spectrometry; SELDI = surface-enhanced laser desorption/ionisation mass spectrometry; HPLC = HPLC for protein purification; Protein array = protein array technology.