Getting Clinical Trials Back on Track

I think it is fair to say that R&D is the lifeblood of the pharma industry, and no drug discovery program can be completed without its clinical trials. As with many aspects of our lives and work, the COVID-19 pandemic has had a huge impact on clinical trials. Currently, the pandemic is hindering the progress of ongoing studies, leading to widespread bottlenecks in drug development processes. On the other hand, many experts seem to believe that the pandemic will have a positive impact on upcoming clinical trials, as it has made us rethink efficiencies, the use of helpful technologies, and might even speed up some standard processes in the future.

We all like a happy ending, and I would love to think that some good could come out of all this, so what do we need to do, to make sure we come out of this situation with something better?  

First, we need to unblock the clinical trial bottlenecks caused by the COVID-19 pandemic. Thousands of trials (an estimated 80%) were stopped or interrupted as a result of the COVID-19 pandemic. These stoppages were because of the difficulties of continuing under lockdown conditions, or with enrolling new patients, or due to the risks associated with vulnerable patients attending site visits. At the same time, other trials have been delayed because time and resources have been re-focussed on finding treatments and vaccines for COVID-19 instead.

In order to get those trials back on track, researchers and clinicians have been adopting a range of novel approaches. The monitoring of patients is possibly the most significant challenge facing ongoing trials, and clinicians have been rising to that challenge by using video calls in lieu of in-person clinic visits. Virtual meetings via teleconferences and video calls can also enable effective team discussions relating to administrative, ethical, legal, regulatory and clinical matters. In order to protect vulnerable patients, trials sites are distributing test drugs by courier, direct to the study participants, instead of by collection from the trial site. I was also interested to read recently that some researchers and healthcare supply companies are starting to use AI for more efficient, remote baseline screening prior to study entry.

As well as these practical solutions, we also need to advocate for the resumption of non-COVID trials. The focus on COVID-19 treatments and vaccines last year was understandable, but COVID-19 is not the only killer disease out there! As we turn our gaze from other illnesses and conditions, in our quest to “beat the virus”, I am concerned that we might soon approach a point at which more people will die from other diseases, as a result of neglect while the world focuses solely on COVID-19, than die from COVID-19 itself. In particular, for many patients who turn to clinical trials as a last resort for cardiovascular conditions, or who have cancer, the resumption of non-COVID-19 trials is a vital potential lifeline that gives precious hope as well as potential medical intervention.

Meanwhile, what do these changes mean for the future of clinical trials? As with many of us who now appreciate the efficiencies of home working over commuting to a mid-city office every day, or who are sensitive to the fact that avoiding multiple transatlantic trips each year could go a long way to helping with the looming world climate change crisis, could our solutions to current challenges show us a better way to run future trials, even when current restrictions are lifted? Surely it cannot be denied that telemedicine might be more convenient, comfortable and safer for severely ill study participants, not to mention cheaper for sponsors if travel costs don’t need to be reimbursed. It might also broaden catchment areas for recruiting eligible participants, while the use of AI for screening must surely be more efficient than organising staffed visits for each individual potential candidate. Building on these developments, and others, it has even been suggested that the future of clinical research might comprise virtual or decentralized trials – site-less clinical trials utilizing non-traditional approaches that do not involve any in-person visits at all.

Our experience with COVID-19 trials has also changed some of our expectations. Is it possible that the breakneck speed of vaccine development in 2020 could lead to accelerated timelines for other therapeutics in the future? This time last year, it was “well known” that it took 14 years to develop and launch a vaccine… but now we can do it in less than one? Obviously, we have just witnessed an exceptional year in which not all normal rules applied, but it does seem to make some of our previously accepted timelines and assumptions laughable. And if we can shorten the timelines on drug development to a meaningful extent, and consequently if we can extend sales-before-patent loss times significantly, does that mean that drug costs might come down, as drug companies have a longer period of exclusivity to recoup their development costs?

In summary, there might be a silver lining. Creativity, ingenuity, flexibility and pure determination on the part of clinical trial teams have led to an accelerated uptake of new technologies and opportunities for using remote healthcare. This is driving a revolution in clinical trial design, as more companies are considering the advantages of decentralized, site-less trials and the use of other non-traditional approaches that do not involve in-person visits. These changes have the potential to reduce costs, hasten recruitment and shorten trial times, bringing more life-saving treatments to market more quickly. Surely these are all good things. We may yet have our happy ending after all.

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. She subsequently began a new career in publishing as Editor of Speciality Chemicals Magazine, and then Editorial Director at Chemicals Knowledge. She now focusses on providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.