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Letters to the Editor |
1 Sezione di Chimica Clinica, Dipartimento di Scienze, Morfologico-Biomediche, Università degli Studi di Verona, Verona, Italy
2 Dipartimento di Medicina Laboratorio, Università di Padova, Padova, Italy
aAddress correspondence to this author at: Istituto di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10, 37134 Verona, Italy. Fax 0039-045-8201889; e-mail ulippi{at}tin.it.
To the Editor:
Advances in laboratory sciences have raised expectations of discovery of clinically useful biomarkers, but few such new tests have appeared to date. Hortin et al. (1) highlighted several challenges in the translation of promising markers into clinical laboratory tests. Translational medicine, which is currently defined as the translation of basic research into practical clinical applications, has great potential to develop and deliver new tools that may assist prevention, diagnosis, and treatment of disease (2). In the field of laboratory medicine, the transfer of promising research assays to daily laboratory practice is a challenge that may take several years and involves many sequential processes: development and validation of clinical assays, release of reagents and systems by diagnostic companies, evaluation of the analytical and clinical performances of the commercial assays in the field, and reliable implementation into clinical practice through training laboratory professionals and refining interpretation and utilization of the new information by all medical personnel (3).
Major emphasis is currently placed on uncovering theoretical and methodological difficulties that would explain why only a minority of experimental research has made the transition to the clinical domain and produced new diagnostic tests (1)(4). This inefficiency is attributable not only to obvious and well-recognized drawbacks, such as methodological biases in animal experimentation and differences between animal and human pathophysiology, but also to additional scientific, financial, ethical, regulatory, and practical hurdles (3). Ideally, experimental and clinical research share the same targets of improving disease understanding and cost-effective decision-making. In reality, however, these pursuits frequently evolve through parallel rather than coordinated tracks. Much of the failure in this translation arises from the lack of effective communication between clinicians and researchers; a collaborative rather than competitive relationship between the two groups will be beneficial (3).
Translational investigations typically rely on large research consortiums and population-based plasma banks that couple biomarker information with longitudinal observational data. Basic research, however, usually includes specific hypothesis-driven studies that have small sample sizes and are conducted by independent academic or industry researchers (2). Because of industry support of some basic research in academic institutions, some medical schools, especially the smaller ones, might need to make compromises for fear that companies would suspend funding. Some companies may take ownership of results although academic researchers have generated them. Biased reporting of the clinical benefits of various diagnostic or therapeutic methods may occur because some agreements signed between academic institutions and diagnostic or drug companies require confidentiality of data, often depending on the outcome. As a consequence, negative results may not be emphasized or submitted to medical journals for publication.
Two other problems merit mention. One is the limited funding for developing new diagnostic products in some specific research fields, because industry tends to seek products with a safer return on investment. Finally, there is a serious concern regarding reliability and reproducibility of results because of sample handling; preanalytical variability may influence profiles of some biomarkers. Therefore, the most feasible and standardized collection procedures should be established before results of a novel and promising diagnostic technique such as high-throughput proteomics can be transferred to daily laboratory practice (5).
Few solutions have been proposed to bridge the gap between basic research and clinical and laboratory practice. Accordingly, translational medicine requires reorganization in a thoughtful cooperative manner between basic researchers, clinicians, laboratory professionals, and manufacturers; it should be more clinically driven and supported by funding independent from any potential conflict of interest.
Acknowledgments
Grant funding/support: None declared.
Financial disclosures: None declared.
References
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