Trials database editorial policy
This document sets out the editorial policy for the production of information on our clinical trials database. There is a separate policy document covering the editorial policy for other sections of the site.
The clinical trials database team source trial information in a variety of ways such as through
- The clinical trials database team source trial information in a variety of ways such as through
- Cancer Research UK funding committees
- The National Institute for Health Research Clinical Research Network: Cancer (NIHR CRN Cancer) portfolio of trials
- Experimental Cancer Medicine Centres
- Cancer Research UK 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)
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 writing guidelines 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 or the Visual content assistant 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 the information is up on the site, we work hard to make sure it stays accurate and up to date.
Open trials – We work with trial teams to review the information every 6 months (or more frequently if appropriate for an individual trial).
Closed trials – Unless specifically advised by the trial team, a closed trial will remain unchanged for 18 months after the end of recruitment. At that point, the requesting results process will start (see below).
Trials with results – Once results are added to the site, they will only be updated if further results become available.
During the time that a trial is open to recruitment, we ask the trial team to review the information on the site at least every 6 months. We email them a direct link to the trial information, and ask them to let us know if there have been any changes to the protocol, centres, or estimated end date and if appropriate whether the trial has moved from one phase to another.
If there are any changes to the protocol and/or PIS, we ask for a copy of the new version so we can keep our records up to date. The original trial summary writer (or another summary writer in their absence) updates information on the site in line with any protocol amendments and liaises with the trial team over any areas of concern.
We request updated lists of participating centres regularly for all live trials on the database. The frequency of centre update requests is decided between the trials database team and the trial team. It could be as often as monthly to begin with, and is always at least once every 6 months, unless the trial team specifically advises us that the list of centres won't change for the duration of the trial. A member of the administration team updates the live site and internal records each time we get an updated centre list.
At the beginning of each month the administration staff collate a list of all trials due to close that month. They then contact each trial team to ask for an update on the status of the trial and edit the site accordingly. If the trial is to recruit for longer than initially expected, we edit the ‘end date’ on the site to the new estimated closing date.
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.
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.
As well as the website there is an internal database of clinical trials records. This includes
- All trials on the site
- Any trials we know about but are not yet open (trials that are awaiting ethics approval or sponsorship agreement, or waiting to recruit trial staff etc)
- Any trials that we know about but will not be going on the website, for example if they are due to close too soon to get the information on the site, no longer have an open UK centre, or the trial team have refused permission to put a summary of the trial on the site
- Trials that were being planned, but didn’t go ahead for some reason
The internal database is available to the Patient Information Web Team and the Cancer Information Nurses. It is also available to other selected Cancer Research UK staff, with varying levels of access depending on their role. But it is not available to the organisation as a whole or externally. It includes contact details for members of the trials team, notes from correspondence and useful background information about the trial etc, but not all these fields are available to everyone. We use this database to flag up when trials are closing or when there are checks that need to be made (eg, estimated start date, checking live information, trial results etc).
If agreed by the trial team, we also keep a more detailed record of the participating centres for each trial and whether or not a trial will accept referrals from non participating centres.
This is not published on the site and centres are only identified to potential participants (or someone enquiring on their behalf) after they have discussed their interest in the trial with a member of the information nurse team. If the trial may be appropriate for them, they are advised to take a copy of the information to their own doctor to discuss it further. This process helps prevent patients contacting trial doctors directly and possibly inappropriately.
All information is treated sensitively and confidential information such as the protocol is stored securely. Hard copies are kept in a locked storage room, and electronic copies are kept as attachments on the secure password protected internal database that only the relevant people can access.
This policy will be reviewed on or before February 2017.
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