The Association of the British Pharmaceutical Industry (ABPI) has said that it wants to take transparency to the next level, and has committed to making clinical research more accessible and understandable across the pharmaceutical industry.
Over the past 10 years, there has been dramatic progress in the number of clinical trials that are registered, and the accurate and timely reporting of results.
While there is still some room for improvement, pharma-funded research is now leading the way by routinely disclosing all clinical trial results.
“As an industry, we’ve made great strides in transparency in recent years,” says Bryan Deane, the ABPI’s Director of New Medicines and Data, and author of the annual
clinical trial transparency update.
“We need to take it to the next level, to make published results more widely accessible and open access will be crucial for that. We must also ensure it is understandable through well-written, concise summaries and other engaging formats.”
At an ABPI event last month, experts from across the pharmaceutical industry (including members of Open Pharma), charity and government sectors debated the need for greater transparency within the pharmaceutical industry. This included discussions on open access publishing, increased clinical trial transparency, and improved public and patient involvement in research.
Medical research findings must be more accessible
“What’s important is not transparency for its own sake,” says Dr Jennifer Harris, Discovery and Research Policy Executive at the ABPI.
“It’s about the whole of society making best use of research evidence to improve patient outcomes. Open access publishing is an important tool in helping achieve this.”
Open access publishing has been a focus for the broad open science movement, especially with major public and institutional funders.
September 2018 saw the launch of the Plan S initiative for open access publishing, supported by an international consortium of research funders, including UK Research and Innovation and the Wellcome Trust.
Plan S requires that, from 2021, scientific publications that result from research funded by public grants must be published in open access journals or platforms.
Communication is critical for improving research transparency
Open access is not good enough on its own. Readable summaries are important for the dissemination of research results and inform not just patients, but everybody involved in the development of new medicines and vaccines.
According to the EU’s comprehensive regulations for clinical trials, companies must now create a plain language summary, describing each trial for a lay audience.
The ABPI has been on the front foot, calling for more useful lay summaries – and for them to be better written, more engaging and more understandable.
As patient engagement and demand for information continue to grow, engagement alone is not good enough either.
The future is more transparent and patient centric
The interaction between patients and researchers in both academia and pharma is maturing and deepening, with patient engagement evolving into patient involvement;
for example, in clinical trial design.
Beyond involvement at specific points, there is clear demand to work towards long-term partnerships to improve healthcare.
The ABPI says that it will continue to work on key policy areas, covering issues such as patient centricity, innovation and sustainability, ultimately helping industry make research more open and improve the lives of NHS patients.
Dr Sheuli Porkess, Executive Director at the ABPI, says that pharma cannot risk falling behind on open science, and that her members share a desire to shift the focus of conversation.
She says the industry is committed to the following principles.
- Transparency: the world wants researchers to disclose what they are doing, when, where, how and why – but they should not be doing it just to be compliant.
- Patient centricity: patients are clearly asking for improved access to and understanding of medical research, and researchers should support this.
- Efficiency: faster, more transparent and accessible information means better research, faster, more cost-effective development of new treatments and improved access to those treatments for the patients who will benefit the most.
- International Society for Medical Publication Professionals (ISMPP) white paper (supported by Oxford PharmaGenesis and with involvement from several people
from the wider Open Pharma group)
- Medical Publishing Insights & Practices (MPIP) extensive resources on open access
- Open Pharma
- Working with patients and patient organisations – a sourcebook for industry