Clinical trials database editorial policy

This is the editorial policy for producing information for Cancer Research UK's 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
• Cancer Research UK's Centre for Drug Development (CDD)
• Experimental Cancer Medicine Centres (ECMC)
• other funding bodies including government organisations, other charities and research organisations, NHS Trusts and pharmaceutical companies
• www.isrctn.com
• www.clinicaltrials.gov (a service of the US National Institutes of Health)

Writing and editing

We prepare a summary of the trial when we receive the trial documents. We prioritise this according to the 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
• 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, synonyms or American spellings such as tumor. This is because they are already entered onto the system. 

We include the following keyword terms:

• the words; cancer clinical trial, research and study
• cancer type. This includes 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 of the trial or study, if relevant
• names of treatments. devices used or drugs in the trial. This might include both generic and trade names. We generally only include the names of those drugs or treatments being investigated in the trial. We do not include those that are standard treatments
• 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 EUDRACT numbers (if applicable)
• Cancer Research UK trial numbers (if applicable)

The trial writer produces a first draft of the trial summary. A manager or an experienced writer in the Patient Information Web team edits the summaries. They review the style, content and do a proofread as part of the editing process. The summary writer is responsible for addressing all edits. Further amendments may be needed after feedback as part of the editing process. The trial writer then makes sure the summary is ready for external review.

When preparing the trial summaries, the writers will look for opportunities to increase visual content on site. For example, diagrams, photos and other images. These are included in the summary before it is sent for external review.

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
• research nurse
• pharmaceutical company representative 

They check for factual errors. We ask them not to change the phrasing or style of the document.

The summary writer reviews the comments from the trial team when it is returned 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. We discuss any further issues with the trial team. We aim to come to an agreement that is acceptable to both sides.

Publishing

The summary is ready for publishing when the writer and trial team have agreed on the summary. The summary needs a team managers check if it was originally peer edited by an experienced trial writer. A member of the administration team loads the information onto the website. They add and check all the links in the text in the process.

The writer of the trial summary has a last proofread of the information once it is on the website and makes any changes needed.  Another member of the team also proofreads this before it goes live.

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.

Closed trials

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 change the trial status in the content system. One of the administration team then notifies certain members of 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 also updates the internal records to indicate that the trial is closed.

Requesting results

We include lay summaries of trial results on the clinical trials database where possible.

The administration staff make a note on the internal database when a trial closes to recruitment, This is to make an initial request for results around 18 months to 2 years later. This is 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. This is so the writers can prepare a summary of the results. If not, they make a note of when results are due. This is to 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. If found, they flag 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. This is reviewed externally before being added to the website. This process for writing, editing and approving results summaries mostly reflects the preparation of open trial summaries as above.

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.

Sometimes results are available online but we are unable to find anyone involved with the trial to check a summary for us. If that happens, we add a paragraph to the page to explain, and include a link to any online results.

We try to base the summary on the final published results when possible. But we may at times summarise preliminary results. If this is the case, we ask the trial team if and when further results may be available. According to their response, the administration team make a note 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.

Removing trials

It is important for the database to be current and up to date for our users . In order to do this, we remove trials 10 years after the final results are published. Or 10 years after the closing date if there are no results available. We keep a copy of the information on our internal database.
 

Clinical trials database pro forma

Our clinical trials database template tells you about the information included in each of the sections of our clinical trials database.