Ukraine war offers hard lessons for clinical research industry: H1
The vital clinical trials taking place in Ukraine prior to the invasion have been thrown for a loop thanks to the Russian invasion. Every study put on hold means potentially life-saving new therapies will be delayed in getting to the patients that desperately need them.
Outsourcing-Pharma recently connected with Ariel Katz, founder and CEO of healthcare technology provider H1, about the far-reaching impact Russia’s attack on Ukraine is having on the industry. He also offers suggestions as to how clinical trial professionals and pharmaceutical companies can work to mitigate the effects of both human-made and natural catastrophes in the future.
OSP: Could you talk about how the Ukraine war has impacted clinical research in that country in the weeks since Russia invaded?
AK: Russia’s invasion of Ukraine has devastated the country’s clinical trial landscape. Ukraine is a major hub in the region for pharmaceutical companies to conduct clinical trials, particularly for cancer medications. Merck, Biogen, Pfizer, AstraZeneca, Regeneron, Karuna, and many other companies all had ongoing trials in Ukraine, many of them in Phase III, which is toward the end of the process where safety and effectiveness are measured against existing standard treatments. Hundreds of these trials have now been disrupted.
Clinical trials are long, complex, and expensive endeavors. They typically take between four and six years to complete. They require sophisticated protocols and specialized recruitment of diverse patient populations, with routine monitoring and checkups over an extended period of time. Success and failure ratios in numerous categories and combinations of treatments must be documented. Every possible side effect, toxicity, or risk must be accounted for.
War certainly throws everything into chaos. Much of the data and progress from these trials may be lost forever. Supply chains are cut off so medications can’t reach trial sites. Participants may have to flee to another country and lose contact with the clinical trial personnel. Without consistency, trial results become unreliable.
OSP: What might some of the long-term impacts on clinical studies in the region be?
AK: We don’t know how long this war will last, or what Ukraine will look like when it’s over. It won’t be as simple as picking up where the trials left off. Even if the original data is still available and hasn’t been lost or destroyed, the time gap and limited ability to track and treat the patients will render much of it useless.
The trials will likely have to begin again. But will they? How stable will the region be? Will companies continue investing in clinical trials in an area where conflict could easily erupt again? There are many complications.
New drugs and therapies that could have changed many lives might not hit the market for years. And a number of participants, including oncology patients, won’t receive life-saving treatments. It is a tragedy on an immense scale.
OSP: You mention that pharma industry professionals have the power to mitigate the negative impact such events have on getting medication to the patients that need them. Could you please expand upon that?
AK: The global healthcare community can do a better job at proactively preparing for clinical trial disruption. In the last two years alone we’ve seen two catastrophes disrupt clinical trials on a massive scale: the Russian invasion of Ukraine and the outbreak of COVID-19. In both cases, we were caught somewhat flat-footed and had to scramble to pick up the pieces.
When clinical trials are unable to complete the trial with the resources they have, they typically migrate to places called rescue sites. Usually, this is due to not having enough participants that fit all of their necessary criteria, so the rescue sites act as a buffer to enroll more patients and ensure continuity in the trial.
Under normal circumstances, the clinical trial personnel will know well in advance if it will be necessary to utilize the rescue site. The rescue site can be notified and primed for participation, and there is plenty of time to prepare for the migration.
However, when the disruption is sudden and unforeseen, migrating to rescue sites becomes very difficult. No one is prepared and nothing has been put in place. Having rescue sites at the ready and having the agility and information to migrate swiftly while staying in contact with patients as much as possible needs to be standard practice.
OSP: Is there anything drug development and research professionals could possibly do to prepare for such events in the future so that they can pivot/recover in a way that helps avoid or minimize interruptions?
AK: We can’t predict these events, and we always hope for the best, but we can and should be prepared for the worst. The world is becoming more unpredictable, so we need to be more agile.
Organizations conducting clinical trials should have certain crucial information at their fingertips before they begin and throughout the duration of the trials. They need to know where to find rescue sites that can accommodate a migration should their work get disrupted. They need to be able to search for rescue sites based on unique criteria to find those that meet their needs and continue the trials as soon as possible.
This information needs to be consistently updated so next-best options can be provided if rescue sites become unavailable. Key opinion leaders in specific regions need to be identified, and their contact information needs to be accurate. Participants in the study must be provided emergency contacts to call or email in the event of disruption so they can receive instructions and hopefully continue their treatments and be monitored as much as possible. Clinical trials should also be consistently uploading their own data to secure cloud databases so their results are not lost and can be immediately transferred to a rescue site.
The size and scope of a disruption cannot be controlled, but the more accurate, up-to-date data and information is available, and the more flexibility is built into contingency plans for organizations and for patients, the more clinical trials can be salvaged.
OSP: How can companies like yours help?
AK: H1 is singularly focused on harnessing global healthcare professional (HCP) data. Our tools maintain everything life sciences and biotech companies want to know about HCPs, the work they are engaged in, their affiliations, and spheres of influence.
Our connected knowledge base is a single source of truth that maps out the locations of clinical trials and documents the details of them across the globe. Access to this invaluable information enables the global healthcare community to work together in ensuring companies, doctors and patients can continue their life-impacting clinical studies in the face of sudden and unanticipated disruptions, and patients can find suitable alternatives to continue getting access to their treatments.
