This document sets out the editorial policy for the production of information on our clinical trials database.
Sourcing trial information
The clinical trials database team sources trial information in a variety of ways, such as through:
- Cancer Research UK funding committees
- Experimental Cancer Medicine Centres
- Cancer Research UK's Centre for Drug Development
- other funding bodies including government organisations, other charities and research organisations, NHS Trusts and pharmaceutical companies
- www.clinicaltrials.gov (a service of the US National Institutes of Health)
Writing, editing and proof reading
On receipt of trial documents, preparation of a summary is prioritised according to need to be on the site. This depends on a number of factors such as:
- media interest
- length of time an open trial has left to run
- coverage of trials already on the database
- whether it is funded by Cancer Research UK
Members of the Patient Information Web team write the trial summaries. All information is written in line with our style guide so it is in keeping with our house style.
All trials on the database are keyworded on the content management system. This helps both in house and external search engines pull out appropriate pages when someone does a search. We do not need to include variations on the same phrase, plurals, hyphens or synonyms (including American spellings such as tumor) as they are already entered onto the system.
We include the following keyword terms:
- the words cancer clinical trial, research and study
- cancer type - including different names for the same cancer, such as womb, uterine and endometrial for a womb cancer trial
- trial type - treatment or screening, for example
- phase, if relevant
- names of treatments or drug in the trial, including both generic and trade names where possible. We generally only include the names of those drugs or treatments being investigated in the trial, not those that are in the ‘standard treatment’ arm
- supporting organisations, including acronyms
- trial name or acronym, if it has one
- the chief investigator
- any other terms particularly relevant to that trial
- ISRCTN numbers, NCT numbers and EURADACT numbers (if applicable)
- Cancer Research UK trial numbers (if applicable)
Queries about wording can be discussed between members of the writing team during preparation of each summary. When preparing summaries, writers look for opportunities to increase visual content on site, such as inclusion of diagrams, photos and other images. Diagrams can be created by the Administration Manager and incorporated into the summary before it is sent for external review.
Trial summaries should be edited by a manager in the Patient Information Web team. Reviewing the style, content and proof reading should be done as part of the editing process. The summary writer is responsible for addressing all edits and making sure the summary is ready for external review.
All trial summaries are reviewed externally before we put them on the website. This could be done by a trial coordinator, data manager, chief investigator or research nurse for example, or by a pharmaceutical company representative if appropriate. They check for factual errors, but are asked not to change the phrasing or style of the document.
When the document is returned, the summary writer reviews the comments from the trial team and edits the summary as appropriate. All comments are carefully considered and all factual corrections implemented. We need to maintain our house style and so do not necessarily make suggested changes to wording. Any issues are discussed further with the trial team, with the aim of coming to an agreement acceptable to both sides.
Once the summary writer and trial team have agreed on the summary, a member of the administration team loads the information onto the website, adding and checking all the links in the text in the process.
The writer of the trial summary has a last proof read of the information once it is on the website and makes any changes needed. One of the administration team then notifies the Patient Information Web Team, the Cancer Information Nurses, the team running the trial and other relevant parties to let them know that the trial has gone live. They also maintain the supporting information such as updating the internal database and formulating a list of recruiting centres.
Once a trial has closed to recruitment we immediately mark it 'closed' on the site. This is so potential participants don’t find a trial they are interested in only to be disappointed when they find out it is no longer recruiting.
The administration team will change the trial status in the content system. One of the administration team then notifies the Patient Information Web Team, the Cancer Information Nurses, the team running the trial and other relevant parties to let them know that the trial has closed. The administration staff will also update the internal records re the closure of the trial.
We include lay summaries of trial results on the clinical trials database.
When a trial closes to recruitment, the administration staff make a note on the internal (Oracle) database to make an initial request for results 18 months later. Unless a trial team have specified that results will be available earlier.
They then contact the trial team at that time to ask if results are available. If they are, they make a note of them on our internal database so the writers can prepare a summary of the results. If not, they make a note of when results are due and flag the trial on our internal database to ensure we contact the team again at that time. The timescale varies depending on factors such as the type and phase of trial. If the trial team don’t send results to us, the administration team can search for published results via PubMed and if found, flags this on the internal database.
Writing, editing, and publishing results summaries
When results are available, one of the Patient Information Web team writers prepares a plain English summary, which is reviewed externally before being added to the website.
If we are unable to obtain results for a trial on the site, or a trial team informs us that there will not be any results available, we add brief wording to that effect.
This process for writing, editing and approving results summaries mostly reflects the preparation of open trial summaries as above. If an organisation has informed us that they don’t need to approve individual summaries based on published results, we send a copy of the summary to them for their information.
If the summary is based on preliminary results, the trial team will be asked if and when further results may be available. According to their response, a note will be made on the internal database and the administration staff will contact them again at the appropriate time. Once further results are received, these can be incorporated into the summary with the approval of the trial team.
Policy review date
This policy will be reviewed on or before January 2018.
Clinical trials database pro forma
Our clinical trials database pro forma tells you about the information included in each of the sections of our clinical trials database.