Pharma Focus Asia

THE FUTURE OF RESEARCH

Importance of accelerated clinical trials for evidence-based treatments

Oli Cram, General Manager, Elsevier

Over the past 12 months, the COVID-19 pandemic has heightened the importance of clinical research and its dissemination. It was and continues to be vital that clinical research is carried out rapidly in order to provide clinicians with an effective, evidence-based, response to the global healthcare crisis. As we look ahead, it is important that we re-evaluate the process of accelerated research trials and understand what healthcare organisations can do to ensure that patient safety and quality is not compromised in the path towards progressing evidence-based treatments for patients.

Over the past year, the COVID-19 pandemic has heightened the urgency for clinical research to understand the disease, uncover treatment plans, and develop vaccines to treat a disease that was once unknown to the world. It was equally crucial that findings were swiftly made available to the public, to prevent misleading information from undermining the public health response.

As we look ahead, we must continue to take what we learnt from the accelerated trials and apply them to other diseases. At the same time, we must ensure that patient safety and quality are not compromised as we make progress in evidence-based treatments for patients.

How data helps clinicians make quick and accurate plans

Healthcare data plays an increasingly important role in aiding clinicians and researchers to develop an effective, evidence-based response to tackle the global healthcare crisis.

The World Health Organization 1(WHO) has published over 199,000 pieces of scientific literature on SARSCoV-2 virus since its outbreak. And the figure will continue increasing with discoveries made every day.

When real-time datasets collated from the population are made immediately available, it enables quicker disease pattern analysis, earlier detection, and reduces trials and errors.

This means clinicians can make quick and accurate action plans to improve public health outcomes – especially in the case of the COVID-19 pandemic, where pre-existing information and knowledge are not available.

Case in point, the swift development of accurately targeted vaccines for COVID-19. The first COVID-19 vaccine was approved within 12 months, a process that traditionally takes 10 to 15 years.

What put the development and approval process on fast track was clinicians having access to knowledge about the disease. Speed was the top priority, as was the rigour of the scientific methods used to develop a vaccine backed by evidence-based knowledge. Carefully planned clinical trials were run simultaneously, which generated data that was comprehensive and reliable.

Fostering cross-country collaboration for a more diverse representation

Partnership among researchers is crucial in ensuring mutually beneficial knowledge, skills, and techniques are shared in an effective way.

Since the outbreak of the COVID-19 pandemic, clinical researchers from various countries and institutions have gathered with the common goal of learning more about the disease and finding the right treatment. Along with research trials, the initiation of rapid, collaborative research has been vital in facilitating the continuation of care for COVID-19 patients.

One such initiative WHO lauds is the Global Initiative on Sharing Avian Influenza Data (GISAID) 2. GISAID allowed researchers to post large numbers of SARS-CoV-2 genome sequences online while protecting data providers’ rights. The safe and secure sharing of knowledge among the global scientific community allowed researchers to access the genome sequences of people from diverse backgrounds, helping to inform and guide the research work on COVID-19.

Sustaining strong international collaboration remains important in the days ahead. It encourages the sharing of skills and expertise and diversifies patient populations for clinical trial research. Most importantly, strong international collaboration facilitates the continued provisionof standardised, quality care to patients worldwide.

Paving the future of research by embarking on digital transformation

The future of research will be defined by the lessons learned from the COVID-19 pandemic. As we embark on this journey, we need to ensure that healthcare organisations are structurally ready to accelerate clinical trials – a process that involves the exchange and reusing of large volumes of standardised data.

The acceleration of digital transformation across healthcare systems is integral to enabling access to available data. This allows clinicians and researchers to refine their knowledge, optimise decision support to identify needs, and predict and prevent future crises. Contributed datasets need to be cleaned, standardised, and validated before use to ensure accuracy and quality. They are then integrated into a single repository that holds all the global data so researchers can rapidly perform meta-analysis to answer further research questions.

For example, Elsevier’s COVID-19 Healthcare Hub3 has amalgamated all the latest frontline clinical tools and resources (including the Coronavirus Research Hub 4) for clinicians and researchers focused on coronavirus vaccine, drug, clinical, and other related research, to freely access these evidence-based solutions for their work.

There is also a need for wider adoption of data standards, where healthcare professionals are guided by international practices and research frameworks to allow them to continue working in a sustainable way to deliver patient care and highquality clinical research. This way, we can ensure that patient safety and quality are not compromised by the accelerated research developments, as research methodology and data are backed by evidence and verified by quality checkpoints.

Conclusion

With a coherent and efficient research response which leverages the power of data analytics, we can be better prepared for a future pandemic. Having a transparent and trusted system that clearly communicates what data is being collected — and why — allows clinicians and researchers to access credible, standardised, and integrated data that informs actions in times of a global healthcare crisis.

More importantly, we need to create a culture of collaboration that promotes high-quality research across countries and institutions. This is all underpinned by digital transformation, the foundation for the collection of high-quality healthcare data that can influence clinical reasoning and impact patient care.

References:

1 https://search.bvsalud.org/global-literature-on-novelcoronavirus-2019-ncov/
2 https://www.gisaid.org/
3 https://elsevier.health/en-US/covid-19/home
4 https://www.elsevier.com/clinical-solutions/coronavirusresearch-hub

--Issue 43--

Author Bio

Oli Cram

Oli has worked providing clinical research solutions since 2006 and in that time, he has been a programmer, a tester, test manager, customer support manager, Software as a Service manager and is now general manager at Elsevier. His vision is to use this breadth of knowledge and the support of his experienced team to deliver the next generation of clinical research software solutions. Oli has an Honours degree in Genetics and a Master’s degree in computer science.

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