Key changes for clinical trials translation in 2022January 4, 2022 | News
By Emi Pell, Business Development Director ‑ North America
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.
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.
The CTR isn’t the only EU regulation affecting our clients. The Medical Devices Regulation, which has been applied since 26 May 2021, intends to standardise regulations in areas such as clinical studies.
However, member states interpret and apply these regulations differently. Navigating this changing landscape is therefore vital for any medical devices companies, especially with adherence to how translations should be provided.
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.
Recruiting and retaining diverse patient groups in remote locations using digital media also means creatively communicating in multiple languages. Without face-to-face contact, it is more important than ever to communicate effectively with diverse groups of patients in various languages.
This can be achieved by leveraging native linguists with specialist knowledge in the field who understand that using the correct terminology, tone and style is imperative. Communicating digitally in multiple languages needs to be a key consideration for those responsible for patient recruitment and retention in 2022.
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.
Clinical trials translations
Integrating translated content into these systems is essential to ensure patients are engaging with new technology. At Conversis, we are working with more and more of these technology solution providers to ensure content is provided in patients’ first languages so messaging is clearly understood, well-received, and correctly acted on.
It’s clear that advances in digital technology will continue to enable trials to be conducted remotely to increase enrolments and widen diversity. As sponsors, CROs, and healthcare communications agencies work with technical partners to advance clinical trials, one thing is certain. Conversis will be on hand to ensure studies can be conducted with patients wherever they are based and in whichever language they speak.
Are you and your language service provider ready for these trends? Drop us a line! We can provide a free 1-hour consultation on how to ensure your translations can adapt to these key trends.