Cromos Pharma’s US BDD on COVID’s impact on clinical research and recover for clinical trials sector

It has been over a year and a half since the COVID-19 pandemic hit, causing the deaths of almost 4 million people worldwide[i]. It also precipitated multiple shutdowns of economies and societies around the globe. Many countries, including the US are now well into a recovery phase. As of July 2021, just over 3.25 billion COVID vaccine doses have been administered. However, there are significant differences between countries, with many countries without access to any vaccines[ii]. The pandemic severely affected all industries, not least the clinical trials sector. On one hand, enormous resources and efforts were pumped into the search for coronavirus vaccines and treatments, while other therapeutic areas experienced major disruptions.

As the sector begins to recover, Cromos Pharma’s US BD Director, Nicole Brenna, discussed how her interactions with clients have shown the extent to which the industry was affected. She also talked about how the pandemic accelerated adoption of decentralized/virtual trials and other technologies. Finally, she talked about client priorities now as the industry recovers. Read the Q and A below:

Primary business concerns

Q: From your interactions with clients, what would you say have been the primary business concerns related to the pandemic?

Nicole Brenna:

 “For many in the industry this past year has been focused on survival, as well as some intense firefighting, as the pandemic threw the world into chaos. The pandemic really touched everyone from their personal lives to business lives. In the first instance, clients had to rapidly find ways of protecting their employees and figure out ways of adapting to a remote model of working to ensure their safety. Patient safety was also paramount especially for those involved in ongoing trials. As public health measures saw clinical trial sites closed, this meant a lot of trials were suspended. At the same time, for those who had trials going, especially COVID-related trials they were grappling with major supply chain issues impacting drug delivery and manufacturing of kit needed for studies. Funding also became a major problem for those working on trials related to any therapeutic area other than COVID. As the R&D focus shifted to COVID this meant other clinical trials were paused or delayed.”

Concerns specific to clinical trials

Q: What were the primary concerns specifically related to clinical trials?

Nicola Brenna:

“Safety of patients was obviously the biggest immediate issue for many. Added to this was the difficulty in recruiting patients even to COVID-specific clinical trials. Staffing issues were also a factor as many clinical professionals joined efforts in the frontline of fighting the pandemic. With site closures, companies had to rapidly adapt their working models to remote ones. This meant getting to grips with using electronic consent, enabling direct-to-patient services and initiating or scaling up telemedicine visits. Overall, the sector worked impressively fast to scale up in these areas. It seems as if one silver lining arising from the pandemic will be the more mainstream adoption of technology, accelerating trends that have been apparent for the last several years.”

Q: The entire clinical trials sector was severely disrupted, but can you say a bit about which therapeutic areas were most seriously affected?

Nicole Brenna:

“Well into 2021 companies are still reporting general issues with delayed initiation of studies as well as slow patient enrollment. However, some therapeutic areas do seem to have been hit harder than others. Global oncology Phase II trials were hit badly and oncology studies in general struggled. Delivering patient cancer care during the pandemic became increasingly difficult with staff shortages. Risk of infection for those immunosuppressed patients was also a concern. Other therapeutic areas particularly affected included gastro and hematology studies, which require regular sample collection. These became really difficult to sustain as there was a shift to virtual and decentralized trials.”

Q: What steps did clients take to minimize trial disruption?

Nicole Brenna:

“Remote monitoring, decentralized and virtual trials became the go to options during the pandemic. The sector had already seen an upswing in these prior to the pandemic, but widespread adoption was still a long way off. COVID really accelerated developments in this regard. Besides this, companies continue to look at moving trial recruitment to less affected regions. This is something Cromos Pharma has been helping clients with especially those usually using US and EU regions. We have great in-depth knowledge of high-recruiting countries in Central and Eastern Europe.  We’ve been talking to clients about initiating new trials here, as well as boosting enrollment for studies that have just got back on track.”

Q: As we head into Q3 of 2021, what would you say are clients’ main priorities and how can Cromos Pharma support them?

Nicola Brenna:

 “Clients main priority is to get back to some sort of “normal” and resume trials that were delayed.  Cromos Pharma can support these companies by providing the following: accelerated study start-up timelines, rapid patient recruitment, and up to 40% savings in overall trial costs.  Companies can benefit from our extensive experience in managing all aspects of clinical trials across our regions, including Central and Eastern Europe, to get “back to business”. For companies considering these regions, we are also offering Free Feasibility Reports to help them decide on the optimum locations for their studies.”

Contact:

Find out more about how Cromos Pharma can support your next clinical project and about our Free Feasibility Reports initiative by emailing bd@cromospharma.com. Our team would be pleased to arrange a meeting to discuss your clinical trial needs.

About Cromos Pharma

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range  of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.

Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Turkey to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials. 

We provide accelerated study  start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.

Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing inquiry@cromospharma.com.

[i] Accurate as of 7 July 2021 source: https://coronavirus.jhu.edu/map.html

[ii] Accurate as of 6 July 2021 source: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html