Since March 2020, clinicaltrials.gov has registered over 6,000 trials for COVID-19 or SARS-COV-2. The pillars of development currently span three principal areas – prophylaxis in the form of vaccines, early therapeutics to prevent the onset of serious illness, and treatment of hospitalised disease. There is also emerging interest in developing treatments for post-viral long COVID.
Over the last 16 months, Veramed has worked extensively to support our sponsors’ COVID-19 programmes, principally in therapies for early treatment and severe/critical cases of COVID-19. The worldwide development effort has been striking in its ingenuity with many treatments involving repurposed medicines as well as novel therapies.
It has been a genuine privilege to work on these trials and help to tackle the pandemic. While continuing with my leadership responsibilities, I also rolled up my sleeves to work directly on projects by providing programming oversight expertise. Our mindset throughout has been ‘all hands on deck’ to deliver the best outcomes for our clients and the global public health effort. For me personally, and for the team, we have derived a great deal of satisfaction and meaning from contributing to this effort.
Naturally, there has been a learning curve and challenges along the way. For one, the fast-pace of trials has required significant flexibility from us as individuals and as an organisation. Yet, building on the community ethos at Veramed, we have been able to deliver to often very demanding timelines. At least one of the medicines, a novel targeted antibody, has received emergency use authorisation and is already saving lives – this is a hugely gratifying achievement.
Yet, the pandemic is continuing, and while the most severe effects are somewhat mitigated in parts of the world, there remains a great deal to accomplish as an industry to offer a range of therapeutics, more vaccines, and options for patients suffering long-term disease consequences.
As we look ahead, it’s essential to take stock and reflect on what we have learnt from this period of intense change and dynamic activity.
For me, one of the major learning points is the revelation that the pharmaceutical machine can mobilise more swiftly than anyone could perhaps have expected.
From study conceptualisation to design, protocol review and set up to reporting, the different elements of the project lifecycle have accelerated to unprecedented speeds. As Statisticians and statistical Programmers, we have helped sponsors make fast, accurate decisions – often achieving readout in a matter of days rather than weeks.
In tandem, regulators have also moved exceptionally quickly to review data and facilitate regulatory approval. Indeed, one of the standout successes of the pandemic response has been the deeper collaboration between individual pharmaceutical companies and between private and public sector organisations.
As we move forward, one of the questions we need to ask ourselves and address is how we can replicate these accelerated timelines and enhanced collaboration to create an improved post-COVID development landscape.
So far, much of the productivity gain has understandably been through additional time and effort at the coalface from sponsors, CROs and regulators. However, there is now an opportunity to capitalise on the changes catalysed by the pandemic to drive faster product development through process innovation and technology – working smarter rather than necessarily harder to enable sustainable change.
Even pre-COVID, we were on the cusp of a paradigm shift with new data technologies, real-world evidence, and advanced analytical techniques allowing more efficient research. Importantly, we now know that the industry can move mountains, and we have a once in a lifetime opportunity to build on this existing foundation.
At Veramed, we are proud to have played our part in the COVID-19 response to date and are inspired by the renewed potential for a leaner, faster drug development future underpinned by technology and efficient data analytics. We already have several initiatives underway and a passionate, dedicated team in place to take up the challenge ahead.
To learn more about our statistical consultancy services, click here or get in touch below.
