Pragmatic Trials Endorsement
Apply for ERS endorsement for your pragmatic clinical trial
There is a gap between the market approval of new drugs and real-life clinical practice, which is not currently fully addressed by the commercial sector. This has led to the belief that more pragmatic trials, designed to show the real-world effectiveness of the intervention in broad patient groups, are required.
ERS is a leader in the respiratory field and as part of the ERS initiative to encourage and support high-quality education and research, it offers external parties an opportunity to promote the endorsement of their pragmatic trials.
What are the benefits of getting your pragmatic trial endorsed by ERS?
- ERS is a European organisation with over 36,000 members. We partner with national respiratory societies around the world and as such have an ideal audience to which we can help promote your trial
- ERS is a leader in the respiratory field and endorsement shows a ‘seal of approval’ which you can establish by including our endorsement and logo on your related materials.
What is a pragmatic trial?
There are several papers which offer a thorough definition of a pragmatic trial (see the New England Journal of Medicine as an example), but for the purpose of seeking endorsement by ERS, the criteria has been clearly defined.
Criteria for endorsement
Your proposed trial should be :
- an interventional randomised control trial
- open label
- an international trial
- focused on real-world settings
- independent and investigator initiated
- led by a European country
- approved by the competent authorities
- registered as part of a trial registry (example: www.clinicaltrials.gov)
- focused on one of the eight major disease domains (airway diseases, interstitial lung disease, paediatric respiratory diseases, pulmonary vascular disease, respiratory critical care, respiratory infections, sleep and breathing disorders, and thoracic oncology )
- agreed collaboratively with the relevant ERS assembly and relevant clinical research collaboration if applicable) according to topic
- able to demonstrate adequate methodology and a primary endpoint (effectiveness)
- able to demonstrate adequate quality assurance and pharmacovigilance processes
- in a position where funding is in place. Note: ERS cannot endorse pragmatic trials where financial support is from a single sponsor from industry or a for-profit entity.
How to apply:
If you would like ERS to endorse your pragmatic trial, please:
Read the Pragmatic Trials Endorsement Guidelines carefully to ensure your application is valid
Complete the Pragmatic Trials Endorsement Application Form
Ensure you have all supporting documentation before submitting:
- CV and GCP certificate of the coordinating investigator/principal investigator
- Clinical trial protocol
- Regulatory approval for the leading country
- Conflict of Interest of the coordinating investigator/principal investigator (page 3 from the application form)
- Report of peer-reviewing processes by major funders (if any)
Email your application and all documents to firstname.lastname@example.org
What is the timeline from the point of application?
Please plan for a four-month response time from the point of sending your application to receiving a decision by ERS.
Until official ERS endorsement has been confirmed, it is not permitted to use the ERS name or logo as part of trial materials.
Endorsed Pragmatic Trials
|Endorsed on||Pragmatic Trial title||Principal Investigator||Information|
|01.02.2019||PTE-2018-01 - Predictive Factors and Magnitude of Response to Omalizumab and Mepolizumab in Allergic and Eosinophilic Severe Asthma: A Multicenter Pragmatic Trial in Belgium||Charles Pilette||-|