Review article: Biomedical intelligence
Vol. 148 No. 1718 (2018)
The impact of clinical trial units on the value of clinical research in Switzerland
- Belinda von Niederhäusern
- Annette Magnin
- Christiane Pauli-Magnus
A prominent 2014 series by The Lancet on “Increasing value, reducing waste in biomedical research” provided recommendations on how to optimise precious resources, including in clinical research. Despite being ideally placed to lead the movement in patient-oriented clinical research, academia struggles to take corresponding measures and find ways to evaluate their impact.
A decade ago, Swiss stakeholders established constructive initiatives to improve the quality of clinical research, including a national Clinical Trial Unit (CTU) Network, predominantly rooted in university hospitals. At the 10th anniversary of this network (2007–2017), we reflect on the CTUs’ trajectory and review whether – and how – they have been successful in improving the value of clinical research conducted in Switzerland.
Anonymised surveys with involved clinical research stakeholder institutions and CTU customers at university hospitals suggest that the CTU Network has positively influenced the quality of academic clinical research. Future goals should include standardised education on Good Clinical Practice; the establishing of an audit function; the positioning of the network as an “entrance gate” for international trials; and support for young scientists launching their careers. Although stakeholder feedback has been very positive, praise does not constitute a standardised measure of the actual impact of CTU services. Beyond that, a broad understanding and practical guidance on how to increase value in academic clinical research are still lacking.
We conclude with ways forward, including “INcreasing QUality In clinical Research” (INQUIRE), a comprehensive framework for the practical assessment of quality in academia developed by the CTU Basel. INQUIRE, founded on consensus across international and Swiss stakeholders, outlines six key quality dimensions to be fulfilled study-wide and is available for all relevant parties involved. INQUIRE encourages academic institutions to adopt waste-reducing strategies and strives to build an evidence-based clinical research landscape in Switzerland, with national and international influence.
- Dorsey ER, de Roulet J, Thompson JP, Reminick JI, Thai A, White-Stellato Z, et al. Funding of US biomedical research, 2003-2008. JAMA. 2010;303(2):137–43.https://doi.org/10.1001/jama.2009.1987
- Moses H, 3rd, Matheson DH, Cairns-Smith S, George BP, Palisch C, Dorsey ER. The anatomy of medical research: US and international comparisons. JAMA. 2015;313(2):174–89.https://doi.org/10.1001/jama.2014.15939
- Ioannidis JP, Boyack KW, Klavans R. Estimates of the continuously publishing core in the scientific workforce. PLoS One. 2014;9(7):e101698.https://doi.org/10.1371/journal.pone.0101698
- Galsworthy MJ, Hristovski D, Lusa L, Ernst K, Irwin R, Charlesworth K, et al. Academic output of 9 years of EU investment into health research. Lancet. 2012;380(9846):971–2.https://doi.org/10.1016/S0140-6736(12)61528-1
- Heinig SJ, Dev A, Bonham AC. The U.S. Public’s Investment in Medical Research: An Evolving Social Contract. Am J Med Sci. 2016;351(1):69–76.https://doi.org/10.1016/j.amjms.2015.10.016
- Al-Shahi Salman R, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85.https://doi.org/10.1016/S0140-6736(13)62297-7
- Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, et al. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383(9912):156–65.https://doi.org/10.1016/S0140-6736(13)62229-1
- Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66.https://doi.org/10.1016/S0140-6736(13)62296-5
- Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267–76.https://doi.org/10.1016/S0140-6736(13)62228-X
- Ioannidis JP, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, Moher D, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet. 2014;383(9912):166–75.https://doi.org/10.1016/S0140-6736(13)62227-8
- Macleod MR, Michie S, Roberts I, Dirnagl U, Chalmers I, Ioannidis JP, et al. Biomedical research: increasing value, reducing waste. Lancet. 2014;383(9912):101–4.https://doi.org/10.1016/S0140-6736(13)62329-6
- Lo B. Serving two masters--conflicts of interest in academic medicine. N Engl J Med. 2010;362(8):669–71.https://doi.org/10.1056/NEJMp1000213
- Binder R, Friedli A, Fuentes-Afflick E. The New Academic Environment and Faculty Misconduct. Acad Med. 2016;91(2):175–9.https://doi.org/10.1097/ACM.0000000000000956
- Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016;352:i637.https://doi.org/10.1136/bmj.i637
- Kasenda B, von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311(10):1045–51.https://doi.org/10.1001/jama.2014.1361
- Meador KJ. Decline of clinical research in academic medical centers. Neurology. 2015;85(13):1171–6.https://doi.org/10.1212/WNL.0000000000001818
- Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PM, Korevaar DA, et al. Increasing value and reducing waste in biomedical research: who’s listening? Lancet. 2016;387(10027):1573–86.https://doi.org/10.1016/S0140-6736(15)00307-4
- von Niederhäusern B, Schandelmaier S, Mi Bonde M, Brunner N, Hemkens LG, Rutquist M, et al. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality. PLoS One. 2017;12(7):e0180635.https://doi.org/10.1371/journal.pone.0180635
- Interpharma: Fewer clinical trials 2017 [Internet]. [18 November 2017] Available from: http://www.interpharma.ch/fakten-statistiken/4539-fewer-clinical-trials.
- Akert K, Fey H, Gautier E. Bericht «Medizin Schweiz», Koordination der Forschungsfinanzierung: Standortbestimmung bestehender sowie Förderung der Bildung neuer Kompetenzzentren biomedizinischer Grundlagen-und klinischer Forschung. Bern: 1994.
- Schweizerische Wissenschafts- und Innovationsrat. In der Schweiz hat die klinische Forschung Mühe, mit der hohen Qualität der biomedizinischen Grundlagenforschung Schritt zu halten. 2002. Report 3/2002.
- von Niederhäusern B, Fabbro T, Pauli-Magnus C. The role of Clinical Trial Units in investigator- and industry-initiated research projects. Swiss Med Wkly. 2015;145:w14161.
- Federal Offfice of Public Health. Master plan of the Federal Council, Boosting Switzerland as a biomedical research and technology centre. 2013.
- Demotes-Mainard J, Kubiak C. A European perspective--the European clinical research infrastructures network. Ann Oncol. 2011;22(Suppl 7):vii44–9.https://doi.org/10.1093/annonc/mdr425
- Swiss Clinical Trial Organisation SCTO. Guidelines for Good Operational Practice V2.0. 2013.
- Swiss Clinical Trial Organisation [Internet]. [16November 2017] Available from: https://scto.ch/de/news.html.
- Swiss Clinical Trial Organisation [Internet]. [17 February 2018]. Appendix 4: Training and Education in Clinical Research in Switzerland. Available from: https://scto.ch/de/publications/guidelines.html.
- Grünig M, Weiss C, Meier-Abt P. Swissmedic durchleuchtet Clinical Trial Units. Schweiz Aerzteztg. 2012;93(03):54–5. doi:.https://doi.org/10.4414/saez.2012.16582
- Publications SCTO. SCTO Short Report 2016 [Internet]. [05 October 2017]. Available from: https://scto.ch/de/publications.html.
- Guidelines for Good Operational Practice V2. 0 2014 [Internet]. [06 February 2016]. Available from: http://www.eoc.ch/dms/site-eoc/documenti/documenti/SCTO20good20operational20practice.pdf.
- Swiss Clinical Trial Organisation [Internet]. Symposium 2017 [17 November 2017]. Available from: https://www.scto.ch/de/event-calendar/symposium/symposium-2017.html.
- von Niederhäusern B, Schandelmaier S, Mi Bonde M, Brunner N, Hemkens LG, Rutquist M, et al. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality. PLoS One. 2017;12(7):e0180635. doi:.https://doi.org/10.1371/journal.pone.0180635
- Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393.https://doi.org/10.1371/journal.pmed.1000393
- Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000;32(4):1008–15.
- Programmes SNSF. Investigator initiated clinical trials (IICT) [Internet]. [04 October 2017] Available from: http://www.snf.ch/en/funding/programmes/iict/Pages/default.aspx.