Trilogy Writing & Consulting gains PIF TICK accreditation to be recognised as a ‘trusted information creator’

August 2022

Trilogy Writing & Consulting has been awarded the PIF TICK – the UK’s only assessed quality mark for print and online health and care information.

To be awarded the ‘trusted information creator’ status, Trilogy had to undergo an assessment showing it met 10 key criteria.

This means you can be assured that what you are reading, watching, or listening to is evidence-based, understandable, jargon-free, up-to-date, and produced to the best possible standard.

Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, said: “Gaining the PIF TICK shows we have a strong process for developing our clinical and scientific communication documents. It is clear that the demand and need for information for the non-specialist audience is growing, and it is equally clear that with the current information overload it is difficult to know what to trust. This quality mark is an unequivocal way for people to be assured our information is reliable and trustworthy.”

The PIF TICK, which launched in May 2020, is run by the non-profit Patient Information Forum (PIF).

In July 2021, a public website, www.piftick.org.uk, was launched to raise awareness of PIF TICK-accredited members and help people find trusted health information.

The site also includes guides on topics including spotting false health information and understanding evidence.

PIF TICK manager Dan Wills said: “We are thrilled to welcome Trilogy Writing & Consulting to our ever-growing community of accredited PIF TICK members. Accurate, accessible, evidence-based information is key to increasing patient empowerment and improving health outcomes.”

For more information, please go to: www.pifonline.org.uk

 


 

The Consequences of EU Regulation 536/2014

February 2022

European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, as the Clinical Trials Information System (CTIS) went live. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via the CTIS. It contains the centralised EU portal and database for clinical trials required by the Regulation, and it is maintained by the European Medicines Agency, in collaboration with the Member States and the European Commission.

The goal of the Clinical Trials Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation requires:

• Consistent rules for conducting clinical trials throughout the EU,
• Information on the authorisation, conduct, and results of each clinical trial carried out in the EU to be publicly available.

This increases the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States. It aims to foster innovation and research while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.

With the opening of the portal for upload of Clinical Trial Lay Summaries, the requirement for Lay Summary production is now mandatory. Sponsors are required to submit a summary of the clinical trial results to the publicly available European database 12 months after the end of the trial.

If you would like to learn more about Lay Summaries, please visit our page dedicated to this document.


 

The Medical Devices Regulations (MDR) of 2017 increased the requirements for documentation of clinical data in support of License Applications

Prior to 1993, documentation of a medical device’s clinical safety and performance was given much less attention than the documentation of its manufacture and quality. Since June 1993 a series of regulatory efforts were made to improve the safety of medical devices.

 

MDD = Medical Devices Directive (93/42/EEC); MDR = Medical Devices Regulations (2017/745)

In April 2017, the MDR was released and made the clinical evaluation of medical devices statutory for access to the EU market for all classes of Medical Devices. Although new guidelines derived from the MDR are expected, including guidance on specific types of devices, the MEDDEV guidelines relating to the clinical evaluation have remained largely valid. The MDR strengthened the requirement for the clinical evaluation of medical devices, particularly the need for a thorough documentation of pre-clinical and clinical data relating to the safety and performance of the device. The amount of pre-clinical and clinical data required for documentation depends largely on the level of risk to health and safety associated with the use of the device. Several new document types have been introduced:

  • Clinical Evaluation Report (CER)
  • Clinical Development Plan (CDP)
  • Clinical Evaluation Plan (CEP)
  • Post-market Clinical Follow-up (PMSF) Plan
  • PMSF Report
  • Failure Modes and Effects Analysis (FMEA)
  • Clinical Investigation Plan
  • Clinical Investigation Report

Not all these are required for all devices but a CER is now mandatory for all medical device license applications in Europe. For the regulators (Notified Bodies), the CER is a key element in assessing the fitness of a medical device for clinical use.

Details on the requirements of the clinical evaluation of a medical device were first provided in the MDD but details on the content of the CER first appeared in the EU MEDDEV Guideline 2.7/1 rev 4 (2016). It documents the clinical evidence that supports a licensing application and, after approval, it is regularly updated to enable the device to remain on the market.

The CER describes the clinical evaluation of the medical device and, according to the MDR 2017, “… shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims in respect of the device.”

The CER is a stand-alone document and is submitted as an attachment to the Technical File. It contains:

  • an assessment of the evidence of the device’s safety risks and expected clinical performance, and, in the updates, additional clinical data on its safety and performance in the field, using evidence actively acquired by the manufacturer during the post-marketing clinical follow-up,
  • a regularly updated review of relevant published literature, and,
  • depending on the class and type of device, data from clinical investigations of the device.

The EU MEDDEV Guideline 2.7/1 rev 4 (2016) remains the currently accepted guidance on the processes of clinical evaluation of medical devices and includes guidance on the structure and content of the CER. It proposes a table of contents for the CER that is now widely accepted as the standard.