Increasing the Efficiency of Clinical Trials
In this interview, Georg Schulz, EVP of Clinical Services & Senior Director of Corporate Development at Tanner Pharma Group speaks with The Medicine Maker about increasing the efficiency of clinical trials. He also offers his perspective on the trends and challenges affecting clinical trials, including the growing prevalence of digital and decentralized trials and COVID-19 induced supply chain issues.
Clinical trials have always had their challenges. Prior to the pandemic, what were the biggest challenges companies faced in terms of getting trials up and running?
There was what I would call a ‘crippling pandemic’ in clinical trials, which is the constant struggle to adhere to the timeline. Many or even most clinical trials run into problems of not being on schedule for a variety of reasons and it has become increasingly difficult to recruit the patients as a result of not only saturation in hospital sites, but also entire countries becoming quite saturated.
This means here is a constant effort required, particularly for CROs supporting patient enrollment, to access new markets and new regions with often unknown or incomplete regulations. Along with this, they also must stay on top of and ensure compliance with a dynamic regulatory environment. I think depending on whether a clinical trial sponsor is a big multinational company with good resources on the ground, or whether you are a biotech company that is perhaps just doing the first phase two or three global clinical trial, the challenges can be really enormous in just getting the process started let alone keeping it on track as it goes across several years of investigation.
The pandemic has certainly affected clinical trials. What are the biggest lessons that will be take taken forward?
In terms of some of the lessons, I think first and foremost I would point out the important realization that decentralized and virtual trials can help overcome certain constraints that exist on the site level. These types of study designs existed prior to the pandemic but were certainly accelerated out of necessity. This of course created new pressure points for the industry in terms of course and compliance of patient data capture, as well as supply chain management and how to make product available to patients.
Another point is that it’s often a struggle for individual sponsors, and I think probably for the industry at large, to process the volume of clinical trials. If I’m not mistaken, by the end of 2020 and the first year of the pandemic, there were about 2,500 clinical trials registered in the U.S. clinicaltrials.gov portal. Both companies and regulators are looking at the opportunity of greater collaboration to streamline different activities with an aim to reduce the workload and identify ways to process the task faster.
One other learning point is perhaps the need for greater emphasis in risk management and risk assessment in the planning of a clinical trial. Perhaps there was not enough consideration given to risk management in the past. I’m referring to, for example, topics like the sudden surge in transportation demand for certain control temperatures, as well as the general shortage of medical supplies and availability of comparative drugs or concomitant medicine, or even simple cell line vials that were short of supply. This happened in part as governments are reclassifying and expanding the pool of what they consider critical medicines to be kept on stock in a country and creating export prohibitions; at the same time, certain antiviral drugs became candidates for COVID-19 treatment and were used in a different volume than anticipated.
So, I think supply chain and risk are extremely noteworthy because ultimately if a clinical trial is not supported by an adequate and risk-free supply chain, it can very quickly cause disruptions to the materials that they need to support the trial. I feel the industry has maybe become a bit more aware of those important pieces.
What else do you think the industry needs to focus on now to improve clinical trials? And are there any challenges with things like decentralization?
I think there’s an interesting dimension here, because the use of technology and the emergence of the virtual trial design were the result of the needs of two groups. On one side, there was the need of patients and eliminating the requirement to go to hospital because it was deemed a high-risk environment for healthy subjects in the trial. But on the other side, there was the hospital and their needs and the discussions of how to protect the healthcare workers from exposure to patients who have an infection that could possibly pass on to them. And we consider them both obviously vital to the whole infrastructure, so digitalization and the decentralized trials have created a safe pathway where requirements of both groups can be met, and conditions improved.
I wouldn’t be surprised if technology will mature over time to not only be used in clinical trials, but that this will become a regular part of the healthcare system. With topics like telemedicine and certain medical consultations, we have indeed proven we can do this just as good by way of technology.
Additionally, I think it is important to keep in mind risk management and mitigation planning. Part of good clinical trial planning involves mapping out the risk scenarios. We have seen a number of scenarios recently across all sectors with supply chain risks and geopolitical evolution and monitoring that has led industries to think, “Okay, what are hotspots around the world? And if something were to happen, do we have a plan B to substitute population or regions of possible conflict, or of elevated risk? Because in the end, we’re all trying to achieve a critical timeline, and if something happens, how do we get out of that? Do we have a plan in place that only requires fine tuning, or do we wait until the moment of crisis to conceptualize a plan?”
I mention this topic because with Tanner Pharma’s experience in supply chain management and supporting clinical trials, we have really seen many new risks and shortages of all kinds of products that affect the supply chain in very different ways. We have seen scenarios where simple products like labels for packaging of clinical trial supplies are in short supply because the paper material didn’t come out of China on time. Or in another case, a shortage from the manufacturer producing validated reusable shipper boxes with temperature control because the vaccines have taken up so much of the volume. Additionally, we’ve seen projects come to a grinding halt because essential products are not available, and without product there won’t be a continuation of the clinical trial, even if you do everything else right.
How do you sum up the impact of the pandemic in a few sentences?
I would just perhaps summarize this by saying that the pandemic in some way has really driven the industry to get to a different level of efficiency and innovation. Not everything is necessarily good or to be used in all circumstances, but I think the toolbox has been enriched and it is really down to making smart choices of which tools work best in what circumstance. For the solutions we thought were good solutions in theory, but in practice didn’t work out so well, I think they’re worth a second look to see whether they should be improved or dropped. But overall, the industry in my opinion is definitely in a better place and I think that’s good for patients and that’s good for healthcare in the long run.
Check out the complete write-up from The Medicine Maker and watch the roundtable discussion from which this interview was excerpted here.