A timeline for conducting your clinical trial

This year, in celebration of International Clinical Trials Day on 20 May, BioMed Central has put together a timeline of the stages of conducting a clinical trial. We’ll reveal more stages throughout the week, in the lead up to the day itself. We’ve invited some of the greats in the field to comment on why the stage is important to a trial, what should be considered and why it should be considered at that point in the trial timeline.

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 measure

16th 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…

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Prospectively registering your trial

16th 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…

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Obtaining ethics approval

16th 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…

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The research question and the right design

16th 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…

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Prospective publication of protocols and results of pilot and feasibility works

17th May 2016
Announcement Date : May 17 , 2016Increasing transparency – one of the many benefits of prospectively publishing your pilot and feasibility works

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…

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Logistical planning for trial delivery and data management

17th May 2016
Announcement Date : May 17 , 2016Doctor_talking_with_a_patient

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…

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Writing and publishing your trial protocol and statistical analysis plan

18th May 2016
Announcement Date : May 18 , 2016

 statistics-822235_960_720

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,…

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Recruitment and retention

19th May 2016
Announcement Date : May 19 , 2016
Retention can sometimes seem like Cinderella, left alone and neglected in favour of the ugly sister that recruitment can turn into
Retention can sometimes seem like Cinderella, left alone and neglected in favour of the ugly sister that recruitment can turn into

The next step along our clinical trial…

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Identifying and managing trial sites and staff

19th 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…

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Data collection

19th May 2016
Announcement Date : May 19 , 2016collectdata

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.

 

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Dissemination of findings

20th May 2016
Announcement Date : May 20 , 2016

Needle_and_red_thread

The final step in our timeline relates to the dissemination of your findings. Threaded publications is an important aspect of this step and in this post, Daniel Shanahan explains why this is important and how you can pull all the publications…

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Analysis of results

20th May 2016
Announcement Date : May 20 , 2016problem-449368_960_720

It’s important to think about the analysis of your results and to consider factors such as random sequence generation, allocation concealment and blinding. Here, Isabelle Boutron, Hôtel Dieu Hospital, France, and Senior Editor for Trials,…

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The timeline is now complete! We hope you enjoyed following the steps day-by-day and hope this is a useful resource for you now.

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