How was the last decade for us? In terms of the rapid rise in the volume of work that we delivered, the challenges we took on and the purely interesting nature of the projects, it has been an incredible 10 years.

We are very grateful for the clients, past and present, who gave these opportunities and the partners we have worked with internationally, without whose help, many overseas projects would not have been possible. Much love, gratitude and respect to you all!

This article outlines the projects that stand out, in my mind at least, as ‘milestone activities’ over the past decade.

2010:

Labelling, packaging and product information regulatory review of the Americas

A US company requested a regulatory check of pharma and medical device legislations to prepare for submission of a medicine-device combination product throughout North, Central and South America, as well as the Caribbean. Up until this point, I had conducted regulatory reviews of post-marketing labels for the EMA region only. So, this was an exciting challenge and an important learning experience, such as finding out the requirements for package leaflets in Brazil, Canada, Argentina, USA, and so on. This laid the foundations to expand activity in labelling expertise, in both pharma and other sectors.

A year later, another company from the USA asked us to perform a regulatory check of local labelling, packaging and product information requirements in EMA and EEA countries, European micro-states, Turkey, Russia, Central Asian Republics and Caucasus countries. By 2013, we were also heavily involved in IMP labelling reviews for clinical trials. Since then, we have undertaken labelling review work in other areas, such as vaping, cannabis products, cosmetics, food and drink products, food supplements and nutraceuticals. To date, we have performed regulatory reviews covering over 120 countries.

User test of an IFU and educational materials for an implanted device

We had worked previously on writing and testing IFUs for Class I and Class II medical devices. This was the first time I had gone anywhere near a Class III device, which involved writing and testing an IFU and supporting educational materials for an implanted device. The writing and testing of IFUs for medical devices have been a regular activity for us over the past decade.

2011:

150-participant user test of Risk Management Plan materials across 5 EU countries

A US pharma company contacted us to perform a user test of packaging and Risk Management Plan educational materials as part of a pharmacovigilance initiative. This was the first project that involved participant recruitment in several countries running in parallel. This project, for me, was *the* milestone project of the entire decade because it paved the way for our future multi-country research, which happened almost immediately after this project was completed. These days, a 150-participant, 5-country study feels like a picnic!

Other pharmacovigilance / Risk Management Plan activities that stand out in my mind are a 19-country study of pictogram alternatives for an epilepsy product and a study involving depth interviews with key healthcare professionals to understand the risk of dosage and administration error of a product for cystic fibrosis.

2012:

UX Testing of a healthcare app

I had been involved in usability testing since the late 1990s for decision-support software for use in UK medical practice[1]. This project enabled us to strip-down and fine-tune a Usability Testing methodology. Usability Testing of apps, electronic Clinical Outcomes Assessments (eCOA), websites, health-related software and devices have become a stable stream of business since then.

Steep rise in Cognitive Debriefing of Clinical Outcomes Assessments

I had been involved in Linguistic Validation of Clinical Outcomes Assessments and associated services since 2001, but only as a marginal activity; never exceeding a few projects a month and only a few of those conducted outside of the UK. The year 2011 saw a sharp rise in demand from a number of clients for LV services, particularly patient recruitment, cognitive debriefing, concepts elaboration, Key Opinion Leader research. The number of countries covered in these activities shot up from low double figures to over 190. We gained experience with testing indigenous language patient measures, such as Te Reo Maori, Guaraní, Welsh and Aymará, rarer languages, such as Dholuo, Dhiveli and Oriya, Creole languages, such as Papiamento, Haitian and Mauritian creoles and minority and migrant languages, such as Somali for Sweden, Turkish and Arabic for Germany, Kurdish and Farsi for UK.

In 2012, a multi-country test of a paediatric diabetes Type II project took place and included cognitive debriefing in Guatemala as part of the study. This was the start of a solid and sustained collaboration with the highly experienced Guatemalan consultant I worked with for this study. Five years later, after becoming a full-time and key member of GRC, we have developed a whole team in Guatemala around her expertise. She has since taken on director-level responsibilities within the company.

2013:

Branding support with a difference: brand name creation based on African languages

Occasionally, we do pro-bono work for small NGOs and non-profit organisations. One such project was for a Caribbean-based organisation, who contacted us to help them find a brand name for their social organisation that would convey a sense of community and peace, ideally in an African language. So, we selected twelve key concepts, such as ‘love’, ‘peace’, ‘community’, ‘harmony’, etc. and we chose the top 40 most widely spoken languages in Africa. I believe the matrix method that we developed to choosing the top candidate name was unique. This was a very fulfilling challenge.

2014 - 2015:

Clinical trial consent forms, clinical study diaries and writing lay summaries of clinical trial studies

Although we had been engaged in writing consent forms and Patient Information Sheets for clinical trial consent forms since 2009, we had a steady increase in demand for this activity from 2014 onwards. Most of the work involved writing and editing consent forms to maximise lay comprehension of what patients are signing up to in a clinical study. On occasion, this involved a further step of formative patient comprehension testing to inform the document design process, which was hugely insightful and rewarding. We were also tasked with the translation and validation of consent forms to be deployed around the world. Another constant stream of work has been the writing, validation and testing of electronic clinical study diaries, which forms well over half of all of our business today.

Furthermore, together with long-standing partners in Germany, we became involved in writing lay summaries of the results of clinical trials, which, again, is always a rewarding exercise.

2016:

Patient-Reported Outcome research, development and validation

In an academic and health professional role, one of our founders developed and validated her own Patient-Reported Outcome measure in the area of paediatric and adolescent mental health. The know-how gained from these activities was transferred to the company as a whole, including patient-centred research at the beginning of the process, item development and selection, psychometric properties testing, amongst others.

2017 - 2019:

Increase in pharmacovigilance and health promotion research

Over the past two years, we have conducted analyses of medication errors across Asian and Middle Eastern countries: errors due to prescribing or dispensing mistakes, harm due to self-medication, errors due to technology or to communication: whether spoken, written or electronic communication or in the translation of medication instructions. We were asked to look at the implications of these in terms of pharmacovigilance activities in the countries in question and analyse how this translated into Risk Management Planning. We found this activity absorbing and useful and, as an internal exercise, we spent several months carrying out this research for every country in the world. This gave us a solid global insight into how pharmacovigilance works internationally.

Similarly, in early 2019, our team was asked to look at health promotion activities throughout the Americas, focusing on Spanish-speaking countries in Latin America and English-speaking Caribbean countries. The sponsor wanted us to capture health promotion activities from governments and NGOs to look at:

• Differences between health promotion activities for infectious illness and chronic illnesses, capturing in many countries the health transition, particularly amongst wealthier patients

• When health promotion activities would involve communication in indigenous or Creole languages and how this communication happens, e.g. printed, video, via traditional or new media

• How health promoters design information to combat low levels of literacy

• What forms do health promotions activities take, i.e. mobile, web-enabled, written, spoken, traditional media, and so on.

Following our pharmacovigilance research activities, we decided to continue this research beyond the Americas and cover all countries. The depth of knowledge gained through this exercise and seeing how health promotion activities differ from country to country was been very worthwhile.

What’s next?

We have a solid foundation in information design and testing and patient-centred research. Our key ethos, drive and function is to place the patient as the focal point of our endeavours, regardless of the activity we are engaged in. What I am looking forward to over the next decade is how health communication with patients will evolve.

Will technology and the speed of information make people more empowered, more health literate or more vulnerable? How does policy adapt to technology in health, including health communication? Take, for example, the Package Leaflet or the IFU: paper-based, fold-out, unwieldy leaflets that, much to the pain of those of us involved in their design, production and testing, relatively few people even read. Will they continue to be a feature of medicine or device packs when technology offers much more efficient, cost-effective and very obvious alternatives? Will Competent Authorities help to shape change or will they be reactive, resulting in equally reactive regulatory frameworks, largely out-of-step with the pace of change?

Already, in clinical phase studies, Clinical Outcomes Assessments and patient diaries have almost universally migrated to electronic delivery, as are methods of obtaining patient consent and screening. Health promotion campaigns make excellent use of electronic, audio-visual delivery of effective health messages with tangible, measurable benefits to their target audiences. By contrast, post-marketing product information and the associated regulatory mechanisms seem dowdy and out-of-step. We look forward to seeing and, perhaps, helping to inform, what comes next.

Mark Gibson, Founder and Health Communication Specialist

2nd January 2020, United Kingdom

[1] See, for example, Gibson et al., Multi-tasking in practice: Coordinated activities in the computer supported doctor–patient consultation, International Journal of Medical Informatics, Volume 74, Issue 6, July 2005, Pages 425-436 and Gibson et al., Verbal prescribing in general practice consultations, Social Science and Medicine, Volume 63, Issue 6, September 2006, Pages 1684-1698.

© 2020 [Mark Gibson], protected under British Copyright Law 1988.