Resourcing Clinical Trials during a Pandemic
By Michael Roder Director, Global Solutions, KellyOCG
Clinical trials have never been more important. In the face of Covid-19, the ability to quickly and safely test drugs and vaccines could be lifesaving to millions of people around the world. It’s also crucial that other important treatments for a huge range of conditions continue to be tested, regulated, and produced. But as it becomes increasingly difficult to connect with both the participants and experts needed to run these trials, how can Life Sciences organizations move forward? We take a look at some of the ways the industry is responding to a supply chain under pressure, and the steps organizations can take to ensure they are agile enough to overcome this challenging time.
Remote Clinical Trials Are Transforming the Industry
As early as mid-March, industry reports were suggesting a boom in remote clinical trials. Advances in telehealth and wearables have transformed the ability to virtually monitor and interact with patients. However, the current crisis has accelerated adoption in a sector that has sometimes been resistant to change. It means that organizations must quickly roll out new processes or rapidly expand on existing procedures. However, virtual trials don’t begin and end with tech, there are the logistics of ensuring medical supplies, drugs, and devices get to where they need to be and the manning of call centers and communication hubs to ensure that patients can access the information they need. Simply, remote trials are no less resource-hungry than the traditional kind and Life Sciences organizations must ensure they have access to the expertise they need to put them into practice. This means aligning with global talent partners who have both the impressive reach and clinical know-how to hit the ground running.
Outsourcing is Evolving
Although CROs (contract research organizations) have traditionally been the go-to for large Life Sciences organizations, we have seen an increasing demand for more flexible and collaborative FSP (functional service provider) solutions over the last few years. The ability to quickly plug expertise and resources into an existing setup without losing insight or oversight is an attractive proposition in a shifting clinical landscape. FSPs can bend and flex with changing clinical and business needs, often providing targeted support that allows a Life Sciences organization to focus on its core goals. Now, in the face of a global pandemic, it is this type of scalable talent solution that addresses many of the key challenges faced by the industry.
Regulatory Timescales are Reducing
It usually takes years to bring drugs to market, but in the fight against Covid-19 all bets are off. Regulators around the world are supporting vastly condensed timescales under emergency measures. The FDA, EMA, and CDE have all implemented emergency clinical approval processes and some products have already moved significantly down the pipeline. This reduction in timelines is heartening for those in the race to develop treatments and vaccines, but at the same time it dials up the pressure they face to act quickly. International bans on travel, social distancing guidelines, and shelter-in-place orders mean it’s more difficult for scientists, regulatory experts, clinical operations experts, and healthcare professionals to play their part. The rollout of virtual solutions, remote patient monitoring, and vigorous safety regimes are all helping those in the thick of clinical research to get the job done.
Right now, the future is uncertain across industries. No one can say with any level of certainty what will happen in the next three months, never mind in the coming years, but it seems likely that access to rigorous clinical trials will continue to be a crucial part of the Covid-19 response. Organizations who are operating in the clinical sphere must review their strategic approach to talent, ensuring they have the agility, flexibility, and technology to access the resources they need, whenever and wherever they need them most. They must ensure they are prepared for what’s next, not just to ensure ongoing success but to enable them to meet the unprecedented challenges we face as a global community.