# Quality literature on the design and logistics of conducting a randomized controlled trial

**URL:** <https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060>\
**Category:** design\
**Created:** [February 29, 2020, 12:32pm UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060 "2020-02-29T12:32:24Z")\
**Posts on this page:** 5\
**Page:** 1

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**Author:** ![Elias\_Eythorsson](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/elias_eythorsson/32/2524_2.png) [@Elias\_Eythorsson](https://discourse.datamethods.org/u/Elias_Eythorsson)\
**Post date:** [February 29, 2020, 12:32pm UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060/1 "2020-02-29T12:32:24Z")

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There is a large amount of texts about this topic and it is hard to know where to begin. Are there any that are of particular quality or highly recommended?

Recommended reference texts:

ClinicalTrials: Design, Conduct and Analysis, Second Edition. Curtis L. Meinert

> **[ClinicalTrials](https://global.oup.com/academic/product/clinicaltrials-9780195387889?cc=is&lang=en&)**
>
> First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical...

Statistical Issues in Drug Development, Second Edition. Stephen Senn  
[https://onlinelibrary.wiley.com/doi/book/10.1002/9780470723586](https://onlinelibrary.wiley.com/doi/book/10.1002/9780470723586)

Example of sub-topics of interest are:

- Calculating sample size for a minimum effect size of interest
- Analysis strategies to maximise study power
- Common pitfalls regarding pre-specification; particularly the choice of primary, secondary endpoints, covariates and statistical modeling, and how pre-specification is reported and made available prior to study initiation
- Modern implementations of randomisation procedure and common pitfalls
- Testing the of the quality of blinding and how this is reported
- Allocation concealment, how the robustness of concealment should be monitored, and how it should be reported
- Logistics of conducting a hospital based clinical RCT; best-practices regarding patient flow through evaluation for inclusion and exclusion criteria, randomisation and monitoring
- Reporting and publishing the results of the RCT

Any and all suggestions are appreciated and I would be more than happy to monitor the responses, and edit this post to add the suggestions under the relevant subtopics, with links.

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**Author:** ![pmbrown](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/pmbrown/32/1382_2.png) [@pmbrown](https://discourse.datamethods.org/u/pmbrown)\
**Post date:** [February 29, 2020, 2:07pm UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060/2 "2020-02-29T14:07:52Z")

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see meinert “Clinical Trials: Design, Conduct, and Analysis”, although it’s been a long time since i looked at it [https://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780195035681.001.0001/acprof-9780195035681](https://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780195035681.001.0001/acprof-9780195035681)  
he also has an “insider’s guide to clinical trials”, although i’m not sure i’m familiar with that one  
this is him: [https://en.wikipedia.org/wiki/Curtis\_L.\_Meinert](https://en.wikipedia.org/wiki/Curtis_L._Meinert)

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**Author:** ![numbersman77](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/numbersman77/32/222_2.png) [@numbersman77](https://discourse.datamethods.org/u/numbersman77)\
**Post date:** [February 29, 2020, 3:29pm UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060/3 "2020-02-29T15:29:27Z")

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How to deal with what happens between randomization and evaluation of the endpoint. In the language of the ICH E9 addendum think about potential “intercurrent events” and which strategy to use to handle them.

Link to the addendum: [https://database.ich.org/sites/default/files/E9-R1\_Step4\_Guideline\_2019\_1203.pdf](https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf)

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**Author:** ![Elias\_Eythorsson](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/elias_eythorsson/32/2524_2.png) [@Elias\_Eythorsson](https://discourse.datamethods.org/u/Elias_Eythorsson)\
**Post date:** [June 12, 2024, 8:30pm UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060/4 "2024-06-12T20:30:32Z")

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I am finally in a position to start building infrastructure at my institution for conducting randomised controlled trials. We have decided to start building competence at my institution by participating in a multicenter multinational pragmatic RCT, but our (my) end-goal is designing and running trials myself. I wanted to revive this topic with a slightly different emphasis: can anyone point me to articles or textbooks that discuss the workflows and electronic components that are needed to conduct a good embedded pragmatic RCT? Are there any trialists here on datamethods?

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**Author:** ![pmbrown](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/pmbrown/32/1382_2.png) [@pmbrown](https://discourse.datamethods.org/u/pmbrown)\
**Post date:** [June 20, 2024, 9:45am UTC](https://discourse.datamethods.org/t/quality-literature-on-the-design-and-logistics-of-conducting-a-randomized-controlled-trial/3060/5 "2024-06-20T09:45:21Z")

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some aro’s put their standard operating procedures on their website. Those would tell you a lot, they will point to the infrastructure, how data are handled, archived, systems used etc. The first thing you will need to do is develop standard operating procedures. If you have a good statistician he/she could help a lot because they would have seen sops in other places and it is the data person who is in the middle of it all. Frank Harrell mentioned here, or somewhere else, redcap. He praised it. Are you familiar with it?