Trials database editorial policy

The CancerHelp UK 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 Cancer Research Network (NCRN) portfolio of trials
• Experimental Cancer Medicine Centres
• Cancer Research UK drug development office
• 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 a trial protocol, it is prioritised regarding 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, and coverage of trials already on the database.

Members of the trials team or seconded members of the Clinical Information Nurse team write the trial summaries.  All information is written in line with the CancerHelp UK 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 and NCT numbers (if applicable)
• Cancer Research UK trial numbers (if applicable)

Queries about wording are discussed between members of the writing team during preparation of each summary. When preparing summaries, trial 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 CancerHelp UK Administrator and incorporated into the summary before it is sent for external review. 

New members of the team send first drafts to the database manager for review and feedback. The summary then goes to the Head of CancerHelp UK for final editing and proof reading. Other members of the team, including the Trials Database Manager, send summaries directly to the Head of CancerHelp UK. The Trials Database Manager will also carry out final editing and proof reading to support the Head of CancerHelp UK.

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, the CancerHelp UK Administrator or Admin Assistant 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. The Administrator or Admin Assistant then notifies the CancerHelp UK team, the Clinical Information Nurses, the team running the trial and other relevant parties to let them know that the trial has gone live. S/he also maintains the supporting information such as updating the internal database and formulating a list of recruiting centres.

On receipt of notification of a newly live trial, the Clinical Information Manager or Clinical Information Nurses update the relevant pages on the main part of the website if appropriate. This could be a question and answer or a cancer type research page, for example.

Once the information is up on the site, we work hard to make sure it stays accurate and up to date.

We ask the trial team to review the information on the site at least every 6 months, depending on the trial. 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 the Trials Database Manager 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 CancerHelp UK trials dB 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. The team administrator or their assistant 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 patients don’t find a trial they are interested in only to be disappointed when they find out it is no longer recruiting.

The CancerHelp UK Administrator or Admin Assistant will change the trial status in the admin system. S/he also notifies the Clinical Information Manager or Clinical Information Nurses, who update the relevant page on the ‘main’ site if/where the trial is mentioned. We email the trial team to let them know the trial summary now states it is no longer recruiting.

The administration staff will also update the internal records re the closure of the trial.

We now include lay summaries of trial results on the CancerHelp UK clinical trials database.

When a trial closes to recruitment, the Administrator or Admin Assistant makes a note on the internal (Oracle) database to make an initial request for results 18 months later.

They then contact the trial team at that time to ask if results are available. If they are, s/he makes a note of them on our internal database so the trials writers can prepare a summary of the results. If not, s/he makes a note of when results are due and flags 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 Administrator can search for published results via PubMed and if found, flags this on the internal database.

When results are available, one of the trials team 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.

As well as the website there is an ‘internal database’ of clinical trials records. This includes

• All trials currently live on the site
• All trials on the site that are now closed or have a results summary
• Any trials we know about that have been funded 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 CancerHelp UK
• Trials that were being planned, but didn’t go ahead for some reason

The internal database is available to the CancerHelp UK and information nurse teams. It is also available to a few other selected members of Cancer Research UK, 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. This is not published on the site and centres are only identified to potential patients (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 is 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. When a trial closes to recruitment, we delete the details about participating centres.

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 October 2013.

Trials database pro forma