Real-world evidence: from healthcare to humanitarian assistance
Author: Chris Winchester, Oxford PharmaGenesis
Alleviating human suffering and saving lives is the goal of both medicine and humanitarian aid. The father of medicine, Hippocrates, first expressed the idea that medicine should be based on scientific observation and reason in ancient Greek times. Yet it was more than two millennia later, in 1992, that the formalized concept of evidence-based medicine emerged to reshape healthcare. However, reaching an evidence-based decision in medicine may not be straightforward when confronted by rapidly changing and highly complex situations with multiple ethical, emotional, political, financial and operational considerations. The same issues can clearly be seen in humanitarian aid.
When it comes to choices about treatments or interventions, physicians have long relied on evidence from randomized controlled trials, together with systematic reviews and meta-analyses of these trials. Randomized controlled trials are scientifically robust, but their findings do not always translate into the real world – for example, because they do not necessarily include the types of patients seen in everyday clinical practice. As a result, clinicians, regulatory agencies and organizations that pay for healthcare are increasingly embracing novel forms of real-world evidence on the effectiveness, safety and value of new interventions during and after their introduction.
In healthcare, real-world evidence derives from sources such as electronic health records, insurance billing data, registries and even health apps. Although such evidence lacks the scientific rigour of the randomized controlled trial, it is collected from the complex world of everyday patient care and is therefore directly relevant to clinical practice. There are, however, other factors to consider. How to judge the quality of real-world evidence, how to combine it with other forms of evidence and how to communicate it effectively are subjects of intense research and debate among academics, clinicians and policymakers, as well as within the pharmaceutical industry.
At Oxford PharmaGenesis, our communications work with pharmaceutical companies is based on the new discipline of HealthScience – the clinical, economic, social, behavioural and political understanding that is essential for demonstrating value in the healthcare systems of today and tomorrow. HealthScience involves interaction with and contribution to an evidence ecosystem encompasses all stakeholders. Most pharmaceutical companies have now made public commitments to disclose the results of all their clinical trials. Some have gone even further by mandating that the findings of the research they fund should be publicly available via open access. We would like to see the same approach adopted in humanitarian aid.
We know that evaluating the impact of humanitarian interventions is particularly challenging, and not only because limited infrastructure, staff and time for planning make it difficult or impossible to test new interventions in a randomized controlled trial. As pointed out in a previous blog in this series by Rick Bartoldus from the International Rescue Committee, humanitarian and development work involve longer causal chains than medicine, meaning it can be difficult to evaluate the reasons for successful or unsuccessful outcomes. With this in mind, I would like to pose the question of how the experience of the pharmaceutical industry in real-world evidence collection, interpretation and communication could be brought to bear in the humanitarian sector.
I think that Evidence Aid could play an important role in this. It has a unique approach to finding and summarizing relevant evidence in high-quality systematic reviews, and then making these freely available via its Evidence Collections. At Oxford PharmaGenesis, we are proud to have partnered with Evidence Aid since 2016 and are excited to see our relationship grow.
I am encouraged by the prospect that corporate social responsibility commitments by pharmaceutical companies could go beyond donating medicines in crisis situations or developing vaccines against emerging diseases to helping non-governmental and charitable organizations to generate and report real-world evidence on the effects of humanitarian interventions. I look forward to seeing companies such as Oxford PharmaGenesis playing a role in this endeavour.
About the author:
Chris Winchester DPhil is Chief Executive Officer at Oxford PharmaGenesis, an independent HealthScience communications consultancy. Now in its 20th year, Oxford PharmaGenesis employs over 200 communications professionals in Europe, North America and Asia Pacific. Chris is Chair of the International Society for Medical Publication Professionals (ISMPP), a founder of Open Pharma, led the development of the American Medical Writers Association–European Medical Writers Association-ISMPP Joint Position Statement on the role of the professional medical writer, and has been involved in collaborative research on the value of professional medical writing support and research transparency.