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Key changes for clinical trials translation in 2022
A lot can happen in a year. Take for example the advances in COVID-19 vaccines since the first was granted regulatory approval by the UK medicines regulator MHRA. The unprecedented urgency of everyone involved in clinical trials has contributed to these extraordinary feats. Get more news about clinical trials translation company,you can vist our website!
Life sciences translation experts Conversis has worked with sponsors, CROs and healthcare communications agencies to ensure they’ve been able to recruit and retain patients for clinical trials around the world since 2003.
As we enter 2022, Conversis will continue to facilitate life sciences organisations in developing effective vaccinations for Covid-19. The Omicron variant will require even more extraordinary feats with the need for further clinical trials in international locations.
But it’s not just Covid-19 that will dominate clinical trials in 2022. Let’s have a look at 3 other key trends that will affect translations for clinical trials in the coming 12 months.
1. Tightening regulations
The way that clinical trials are conducted in the EU will undergo a major change when the EU Clinical Trials Regulation (CTR) comes into application on 31 January 2022.
The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, with the adoption of the Clinical Trials Information System (CTIS). The CTIS will contain a centralised EU portal and database for clinical trials.
Translating plain language summaries
The CTR requires the publication of a summary of every clinical trial conducted in the EU within one year of trial completion. These ‘Plain Language Summaries’ must be provided in the official language of each country where the study was conducted. Make sure that you’re prepared for this regulation by reading our article.
2. Increasing decentralisation
Since the outbreak of the pandemic, CROs and healthcare communications agencies have sought to enable more clinical trials to be run in remote settings. Traditionally, clinical trials have taken place in hospital or university settings. However, decentralised, virtual trials have become increasingly popular in recent times.
Why? Mainly because decentralisation eliminates the need to travel to specific sites, offering a more patient-centric approach to clinical trials. During the pandemic, patients’ concerns about an infection on public transportation and in the settings themselves have put a renewed emphasis on the need for virtual trials. For sponsors, CROs, and healthcare communication agencies this means communicating in more remote and digital ways.
3. Technological innovation
The adoption of technology solutions by CROs and healthcare communications to enable these decentralised clinical trials will continue to increase in 2022. In the last twelve months, Conversis has partnered with many companies offering innovative technical solutions for remote trials.
This includes clinical trial management systems, patient recruitment platforms, remote medical devices and more. There has also been a significant rise in solution providers that leverage portals, websites and apps to provide effective engagement platforms for all stakeholders in decentralised trials.
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