Which endpoints to report in clinical trial lay summaries?

In November 2019 the European Commission published a question and answer document in relation to Clinical Trials Regulation 536/2014. The 103 page PDF document is available here. The document includes one question and answer related to which endpoints should be reported in the layperson summary. The full question and answer wording from the document is…

Roadmap Initiative on Lay Summaries of Clinical Trial Results

The European Patients Forum (EPF) is participating in the “Roadmap Initiative to Good Lay Summary Practices”, led by EFGCP and EFPIA, to find a systematic approach to implementing lay summaries and making them “real” by the time the online portal goes live and clinical trial lay summaries become mandatory. This initiative constitutes a kick-off meeting,…

Check out our invited journal article…

Earlier this year we were invited to submit an article to the Medical Writing journal, on the topic of lay summaries in the sphere of generics and biosimilars. You can read the article here: https://journal.emwa.org/generics-and-biosimilars/layperson-materials-in-the-sphere-of-biosimilars-and-generic-medicines/ Below is the abstract: Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use,…

The class of 2019: A student’s perspective on all things pharma

We were keen to get a student’s perspective on the pharmaceutical industry, and in particular what was being taught in universities regarding patient-centred thinking. So we interviewed Raya Koldova, and here’s what she said… Where and what are you studying? I am currently studying for a Bachelor’s degree in Biochemistry and Pharmacology at the University…

ISMPP report the results of their lay summaries poll

ISMPP have presented the results of their poll into whether pharmaceutical companies will allocate internal resources to the development of lay summaries. Of 240 responses, 144 (60%) said ‘yes’. 8.8% reportd that they were unsure. Presumably this means that the remaining 31.3% will outsource the development of their lay summaries? Results available here

EMA update on Clinical Trials Information System

The European Medicines Agency’s (EMA) Management Board held its first meeting in Amsterdam on 21 March.  In meeting highlights released 22 March,  EMA provided the following update on the Clinical Trials Information System (CTIS): The Board was updated on the status of the ongoing development of the Clinical Trials Information System (CTIS – formerly the EU clinical trial portal…

UK Government position on clinical trial transparency

The UK government issued a policy paper on 22 February to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report issued in October 2018. Importantly, in relation to lay summaries of clinical trials, the response to recommendation 1 states: ‘In the event of a negotiated agreement…