Clinical research is essential for bringing to new treatments and vaccines as well as to guide improvements in health management. Good studies are a powerful experimental tool where design, conduct and analysis must be approached carefully if protocol questions are to be reliably answered.
Clinical research needs evidence-led improved methods. The aim of here is to grow a community of researchers who are interested in supporting the generation of more and better evidence to drive improvements in health across the globe.
Successful completion of a study depends not only on appropriate design but also on the way the trial is conducted. The skills and professionalism of those tasked with conducting trials on the ground are central to a trial meeting its objectives with scientific integrity[2,3].
Research regulations are increasingly applied globally, given that many studies are conducted as multi-centre trials that operate across highly varied geographical regions. Across all settings, there are increasing calls for changes in how trials are conducted[4-6]. This is in response to international recognition that clinical research has become too bureaucratic, and that would-be investigators are put off from engaging in research because they perceive that operating studies is too difficult, cumbersome and expensive with complex and restrictive regulations.
In Europe and the US, research efforts to tackle this include the clinical trial transformation initiative (CTTI) and the MRC network of hubs for trials methodology research. Trial conduct has been targeted as a research focus for both these groups, and there have been studies to determine the issues that impede trials in the UK.However there is very little similar research from other regions.
Overall the literature around clinical trial conduct is limited. It would be novel and interesting to focus trial conduct research internationally because such studies could establish whether the issues are the same in different settings, whether findings and tools are transferrable and if globally applicable recommendations can be made.
Here we are seeking to build an open collaboration of groups and individuals who want to engage in developing research methodology studies.
For example clinical trials conducted in challenging and varied settings stand to make important contributions to identifying novel and pragmatic trial conduct methods and approaches:
- Whilst there are differences in the environment and resources between high income and developing countries, the challenges faced when operating trials are largely similar.
- Differences between settings in the environment and resources (including training and experience of staff, and vulnerability and literacy of the population) often necessitate alternative and creative approaches that still meet international standards. Capturing these solutions could benefit other regions.
- It is clear that there is a need to conduct methodology research around and nested within studies to guide improvements to design and operation of studies. Here the aim is to develop such studies and share experiences in this objective.
Please see the how to get involved area for more information. Or please email the editorial team: Research Methodology
- McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, et al. (2006) What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 7: 9.
- Sung NS, Crowley WF, Jr., Genel M, Salber P, Sandy L, et al. (2003) Central challenges facing the national clinical research enterprise. JAMA 289: 1278-1287.
- Murillo H, Reece EA, Snyderman R, Sung NS (2006) Meeting the challenges facing clinical research: solutions proposed by leaders of medical specialty and clinical research societies. Acad Med 81: 107-112.
- Lang T, Cheah PY, White NJ (2011) Clinical research: time for sensible global guidelines. Lancet.
- Yusuf S, Bosch J, Devereaux P (2008) Sensible guidelines for the conduct of large randomized trials (vol 5, pg 38, 2008). Clinical Trials 5: 283-283.
- Tyndall A (2008) Why do we need noncommercial, investigator-initiated clinical trials? Nat Clin Pract Rheum 4: 354-355.
- Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, et al. (2007) Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 11: iii, ix-105.
- Lang TA, White NJ, Tran HT, Farrar JJ, Day NP, et al. (2010) Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis 4: e619.