We have all become well acquainted with the overwhelming sense of unpredictability that has cast a shadow on our world from the growing spread of COVID-19. Challenges have arisen from quarantines, site closures, travel limitations, interruptions to supply chains, and other considerations spanning a multitude of industries. These rapidly evolving circumstances have impacted day-to-day lives, the economy, and the overall clinical trial landscape as we know it.
As the coronavirus crisis has put an undeniable amount of strain on healthcare systems, many drug and pharmaceutical companies have been faced with the decision to delay trial starts and pause enrollment in their ongoing studies. According to FierceBiotech, this includes Pharmaceutical powerhouses such as Eli Lilly who are “slashing clinical trial activities in response to the COVID-19 pandemic.”
The subsequent downstream impact on patients and the drug industry from delays in development worldwide could be substantial. Adam Feuerstein from STAT News states “as Covid-19 spreads, disruptions to clinical trial and drug development accelerate. Without data from pivotal clinical trials, new drug filings will be delayed, meaning some important new medicines will take longer to reach the market.”
Onno van de Stolpe, the CEO of Belgian drugmaker Galapagos, announced the decision to pause patient enrollment in studies of a drug being developed with partner Gilead Sciences that treats diseases of the immune system. A decision made to “help protect patient safety,” Van de Stolpe released in a statement firmly believing that the company will weather this storm and come out stronger. “We are more determined than ever in our unwavering ambition to bring innovation to patients.”
BIO, the clinical research industry trade group, has distinguished two significant changes to the conduction of clinical trials in our current environment. Cartier Esham, BIO’s Senior Vice President of Science and Regulatory Affairs notes these variations as:
- Missing or delayed data collection from ongoing clinical trials, particularly at hospital sites overwhelmed by COVID-19 cases
- Difficulties getting new clinical trials up and running because patients are reluctant to enroll or unable to visit hospitals
Although these changes are shifting the current outcomes of several ongoing and upcoming drug trials across indications, surging cases of COVID-19 are driving new drug trials in search of a cure. Scientists are working tirelessly to formulate new understandings of the virus and the use of pre-existing drugs in the potential treatment.
Hopes are highest for Remdesivir, an experimental antiviral developed by Gilead for use against Ebola but since pressed into study for the new coronavirus. There are now a variety of trials testing Remdesivir’s efficacy in COVID-19 patients, while other nucleotide analogues are also under investigation.
On our end, Catalyst continues to work diligently in programming studies and facilitating projects, and when the time is right, we are ready to start a dialogue surrounding the current climate and plans for pressing forward. Striving to maintain a sense of normalcy throughout times founded in uncertainty and fear, we forge ahead with the knowledge and hope that even the most modest of improvements in existing treatments could make a sizable difference in the containment of the coronavirus crisis.