It all began with James Lind in the 1740s, and his observation that British fleet scurvy caused more deaths than in French and Spanish fleets combined. He hypothesized that the citrus fruit on board the latter were minimizing their risk so on May 20, 1747, took 12 patients on board the British Salisbury and tested whether these fruit would alleviate their scurvy symptoms.
This gave rise to one of the first ever recorded clinical trials and why we celebrate International Clinical Trials Day globally on May 20.
Since Lind’s pioneering work 269 years ago, medical research has come a long way.
This year, BioMed Central has put together a clinical trial timeline; new stages will be added throughout the week, many with comments from those within the field, so that by International Clinical Trials Day (on Friday) the full timeline will be available.
From research design to disseminating the results:
Choosing the right outcomes to measure16th May 2016 Announcement Date : May 16 , 2016
Once you’ve chosen your research question and study design, the next important step is choosing the right outcomes to measure. Here, Mike Clarke and Paula Williamson from the COMET Initiative outline useful tips to take into consideration at…Read more
Prospectively registering your trial16th May 2016 Announcement Date : May 16 , 2016
To register or not register prospectively? That is the question! Once you’ve chosen the outcomes you wish to measure, the next important step is to register your trial. Here Database Manager for the ISRCTN Registry Helene Faure goes over the…Read more
Obtaining ethics approval16th May 2016 Announcement Date : May 16 , 2016
Once you have registered your trial, the next step is to submit it to a Research Ethics Committee for review and, hopefully, approval. We asked the Health Research Authority to provide information on why it is important to gain ethics approval…Read more
The research question and the right design16th May 2016 Announcement Date : May 16 , 2016
Deciding on what research to invest your time and resources into is one of the most important steps in its conduct. Ella Flemyng from BioMed Central talks through this first step.
Research estimates that 85% of research is wasted as it’s not…Read more
Prospective publication of protocols and results of pilot and feasibility works17th May 2016 Announcement Date : May 17 , 2016
The next step to think about is to prospectively publish your protocol and publish your results. To talk us through this point, Lehana Thabane (Associate Chair of the Department of Clinical Epidemiology and Biostatistics) and colleagues Zainab…Read more
Logistical planning for trial delivery and data management17th May 2016 Announcement Date : May 17 , 2016
This next step on the timeline focuses on the stage of logistical planning for trial delivery and data management, including why it is important to consider patients and the wider public in these plans at the early stage of the process. Eric…Read more
Writing and publishing your trial protocol and statistical analysis plan18th May 2016 Announcement Date : May 18 , 2016
In this post we look at the reasons behind why writing and publishing your trial protocol and statistical analysis plan is important, particularly prospectively, and how reporting guidelines are available for this step. Doug Altman,…Read more
Recruitment and retention19th May 2016 Announcement Date : May 19 , 2016
The next step along our clinical trial…Read more
Identifying and managing trial sites and staff19th May 2016 Announcement Date : May 19 , 2016
Next up is identifying and managing trial sites and staff. Here, Johanna Cook and Sarah Tearne discuss why this isn’t as easy as it sounds and they provide some resources as to how the issues around this can be overcome.
The process of…Read more
Data collection19th May 2016 Announcement Date : May 19 , 2016
It’s important for the collection of data to be structured and planned in advance. This means you can be well-prepared and know how your data could be shared, which is also vital for increasing the transparency of yur clinical trial.