Objective 4c: Translating Search for use in ClinicalTrials.gov (search 4)

One of the required searches for your formulary monograph project is a search for relevant trials registered in ClinicalTrials.gov.

Why?

• Almost all trials conducted in the United States during recent years (and many conducted around the world) will be registered in ClinicalTrials.gov.  So a search of this database can give you a nice list of trials.
• You should use the ClinicalTrials.gov list as the starting place for organizing your PubMed search results.   Several journal articles may be produced from the analyses conducted using a single trial’s data.

 (Past students who organized their search results in this way seemed to have an easier time with the project — so this is now required.  ).

How should you go about conducting this search?

It’s important that you understand:

1. 1. that  PubMed tags like [tiab], [mesh], and [sb] will not work will not work in this search interface.
   2. that the amount of text you can enter may be limited.

• Revise your PubMed keyword search so that it will work in ClinicalTrials.gov.  A revised version of the tutorial search is provided below:

(Eculizumab* OR 219685-50-4 OR h5G1.1* OR h5g11 OR h5G1-1 OR 5G1.1 OR Soliris OR Elizaria OR Alexion OR Acveris) AND (((intermittent OR paroxysmal ) AND ( haemoglobinur* OR hemoglobinur* OR haematur* OR hematur* OR haematinur* OR hematinur*)) OR PNH OR Marchiafava-Micheli) AND (Clot OR Clots  OR budd-chiari OR embol* OR postthromb* OR thromb*) 

When working on this portion of your group project:

• • Copy your PubMed keyword search, and paste it into a Word document.
  • Remove any [tiab] tags or any other tags in square brackets.

• Copy the revised search.
• Go to ClinicalTrials.gov
  • Use the linked version of clinicaltrials.gov.  Do not switch to the “classic website” version.
• Paste the strategy into the “other terms” search box.
• Click the “Search” button.
• If you find that the end of your search disappears after you run the search, your search exceeded the length allowed by ClinicalTrials.gov.  You will have to revise the search.  Keep a record of the full-length search in Word (in case you decide to search EMBASE). Make a second copy of the search in Word, and remove terms that are less important.  Use this version to rerun the ClinicalTrials.gov search.  The CAS registry number and any foreign generic names should be among the first terms removed.  Try to retain a drug’s investigational names as these are frequently used in clinical trial registries.

After the results appear:

• Check the boxes next to the trials that appear to be focused on the disease and drug of interest.   You may have to read more of the trial registry record to determine whether the record is actually relevant, but you can do that later.
• If this was your group project search, after reviewing the first page of results, you would move to the next page and to the next until you finished reviewing all results.

• After you’ve selected the relevant results, click the “Download” button to download a list of the results.
• Select the CSV format (CSV files, comma delimited files, will open using Excel on Windows machines and can be imported into Excel on Macs).
• Retain the “Selected” setting  if you have selected the relevant results.
• You may want to “Select all” fields or choose those of interest to you.
• Click the “Download” button.
• You may also want to download a RIS format version of the selected results.  You can import the RIS file into Zotero or another citation manager.

Using the CSV results:

Use of the ClinicalTrials.gov results can be approached in a variety of ways.  The approach I describe might work for you:

• Open the CSV (comma delimited) file (it can be imported into Excel on Macs or Windows machines).  It will open in Excel if double clicked on a Windows machine.  It will open in Numbers if double clicked on a Mac machine.)
• Start by looking at the “Conditions” and “Interventions” column.  Highlight or otherwise mark the rows that do not include the relevant intervention or disease.
• This will leave you with a list of unmarked results that are most likely to be relevant.
• You now have the scaffold for your list.
• As you go through your PubMed results  (and, optionallly, EMBASE results) and begin to identify relevant trials, look for mention of registration with ClinicalTrials.gov or for an NCT registry number.  This number may appear in the article’s narrative or in the ‘extra’ notes that follow the article.  (notes about funding, registrations, etc. often follow the article narrative).
• In a new column or new rows below a trial’s row, list the relevant publications retrieved by your PubMed search that are associated with that trial
• You will need to extract the list of relevant trials and the associated relevant articles identified by your PubMed results (and optionally EMBASE) searches and include this in your monograph assignment.