When the COVID-19 pandemic became widespread in the spring of 2020, many clinical trials paused. A survey conducted in April 2020 found that of respondents, 69% said the pandemic affected their ability to conduct ongoing trials and 78% said the pandemic affected the initiation of new trials.1,2 However, some contract research organizations (CROs), such as PSI CRO, were able to deliver, in their case, 75% of their trials. Nor did they see any layoffs or furlough staff. Although the COVID-19 pandemic was an extreme case of trial disruption, it's unlikely to be the only one. Whether caused by economic problems, supply chain issues, civil unrest, weather, or other factors, disruptions will arise that threaten study timelines. Here are some ways CROs can prepare for the worst and keep their trials moving smoothly.
Support Technology Alternatives
One thing that PSI, other CROs, biopharma, and medical device companies leveraged to continue trials during the pandemic was technology. Often this was the adoption of decentralized or hybrid clinical trials. That is, part or all of the trials were conducted remotely, outside a traditional clinic or hospital. Depending on the trial, this could mean telemedicine devices, wearables, such as smartwatches or other types of sensors, and home visits by nurses. PSI CRO, for example, leveraged remote monitor visits, portals and web-based tools for access, among other approaches.
According to life sciences cloud software company Veeva's "Veeva 2020 Unified Clinical Operations Survey: Annual CRO Report," 3 99% of CRO respondents said they needed to unify clinical applications. In that regard, eClinical applications used by most CROs included EDC (93%), eTMF (82%), and CTMS (73%). But 98% of respondents also said they needed to improve how information was shared between study partners to decrease manual processes (78%), speed trials (61%), and improve collaboration (57%).
Olga Alfonsova, Head of Business Development at PSI CRO, says, "CROs have to be the leading voice of support for sites in the clinical trial process. Each CRA is an ambassador, knowing the ins and outs of the site, the site team, and the unique capabilities of the site. CRAs are the ones to help train the site staff on technology integrations, provide support in any transitions and ensure the site has access to needed information. If a site chooses to go fully virtual, or to telemedicine visits only, our teams can step in and support."
Remain Flexible and Adaptable
Few people expected the severity and duration of the COVID-19 pandemic. CROs that were able to continue trials during the height of shutdowns were able to adapt, demonstrating flexibility in how they kept the trials progressing on schedule. Broadly, the CROs that managed this had lean operations and flexibility where needed as part of their core values. PSI CRO notes that its corporate structure isn't particularly hierarchical, which meant its staff could make decisions quickly to move ahead.
Benefit with Established Partners and Trusted Vendors
Disasters happen. Thankfully, few are as extensive and long-lasting as the COVID-19 pandemic. However, clinical trials can be stalled or delayed for a variety of other reasons, ranging from natural disasters to more typical problems, such as operational issues and enrollment problems. A 2016 study published in Nature found that about 25% of all clinical trial delays were strategic in nature, commercial barriers, or operational issues.4
Too many CROs were caught off-guard by the pandemic by not having relationships in place with partners and vendors. These partners helped with a broad range of site issues, including the technology needed for decentralized or hybrid trials. It's key for a successful CRO to have robust and trusted relationships with partners and vendors that can adapt to changing situations.
Establishing Robust Processes and Infrastructure Key to Staying Ahead
Although each clinical trial is unique, there are aspects in most trials that remain identical. CROs that have commercial clinical trial management systems, or technology platforms that allow for easily adaptable data management, are in a leadership position to offer the flexibility needed to adapt to changing circumstances.
Delays in clinical trials are fairly common—even without a global pandemic. However, delays can be mitigated by proper risk management. This means establishing processes and infrastructure to battle potential issues. Be prepared in advance. Anything can happen, and your team needs to have contingencies in place to shift quickly.
- Sathian B et al. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020 Sep;10(3):878-887. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538012/
- The Impact of COVID-19 on Clinical Trial Sites: The Results of a Global Survey Performed by Medidata. April 2020. https://www.medidata.com/wp-content/uploads/2020/05/COVID19-Site-Survey_20200518_v1.pdf
- Veeva. Veeva Unified Clinical Operations Survey: Annual CRO Report. https://www.veeva.com/eu/resources/clinical-operations-survey-report-2020/
- 4.Harrison RK. Phase II and phase III failures: 2013-2015. Nat Rev Drug Discov. 2016;15:817-808. https://www.nature.com/articles/nrd.2016.184