DATA REPORT: The impacts of COVID-19 on clinical trials

Deep dive into the data from a recent Informa Connect Life Sciences study

DATA REPORT: The impacts of COVID-19 on clinical trials

With the rapid spread of COVID-19, the world’s attention has turned to the life sciences community in search of testing, vaccination and treatment of the virus. At the same time, the associated lockdowns are having huge impacts on the supply chain and working life of those working in the industry.

Informa Connect Life Sciences and BioProcess International magazine conducted a huge survey (14-22 April 2020) of life sciences professionals from the pharma, biotech, medical device and regulatory industries around the world on the coronavirus. The results here are the 116 completions from respondents working within clinical trials or early clinical development. These findings reveal insights into how the clinical trials community is responding to the crisis and the impacts it is having on the field.

Demographics

27% of respondents work for a pharma/biopharma company, and 18% at a CRO/CDMO/CMO

55% of respondents are based in Europe and 31% from North America

Impact

57% of respondents are working on the development of diagnostics, vaccination, or treatment of COVID-19.

Is your company working in any way on the development of diagnostics, vaccination, or treatment of COVID-19?

78% of respondents reported the virus having some impact or a significant impact on their supply chain.

How has the virus impacted your supply chain?

In what ways has your supply chain been impacted? (Selected responses)

Limited Resources

"Availability of reagents and materials."
"Limited availability of healthcare-related PPE."
"Necessity for change of some suppliers due to unavailability of materials."
"Clinical supplies, reference drugs, tissue samples shipments have incurred some disruption."
"Delayed/postponed shipments of laboratory goods."
"Study supplies being re-allocated to COVID-19; staff shortage impacting availability of IP."
"Psychologically via communal stockpiling unnecessarily."

Delays and Demand

"Certain manufacturers that we use are currently not operational which has delayed aspects of our build. We are also about to furlough staff."
"China production delayed for 8-10 weeks. Bioreactors shut down and medial and product to be destroyed."
"Cannot produce enough product."
"Accelerated request/demand for technology for decentralised trial conduct."

"More demand of products, longer lead times and limitation on resources."
"Less commercial meetings for new business development, delays in client projects, shift in emphasis towards COVID projects, long term risk to funding of new projects."
"Our whole life has slowed down. Drugs are disappearing from hospital shelves. Difficulty in border-crossing. Manufacturing plants working at slow pace due to lack of workforce. Etc."
"Ongoing clinical studies interrupted since clinical supplies delivery hampered and hospital visits barred. Heavy loss in safety endpoints and to a lesser extent in pharmacodynamic/clinical endpoints. Major delays in clinical programs expected and very heavy costs."
"Sites are currently not available to perform clinical trials and distributors have different priorities."
"Reduced staff on site."
"Teams working from home is causing delays in processes."
"The factory was less impacted but with the establishment of a lot of cautions. All support and R&D functions have been outsourced to the production site (home work) in order to avoid contamination in the factory."
"Tighter planning and control to be able to react quickly to COVID requests."
"We are tremendously busy and need to man up our organisation."

What changes to regulations and laws do you expect to see in response to the coronavirus outbreak?

Streamlining procedures, relaxing requirements

"A general 'Fast track designation'for highly infective diseases.
"The ability to enact changes in order to address immediate hazards."
"An easing of certain testing requirements and acceleration of review."
"Relaxing requirements for new rapid diagnostic test equipment."
"Change in IVD/IVDR and other regs - hopefully simplification."
Streamlining of any regulatory approvals towards drug and treatment opportunities, within reason."
"Flexibility for ongoing studies has already been granted by FDA, EMA and other regulatory bodies in March and April. This implies a loss of data at all stages for safety and efficacy, especially important for pivotal Phase III studies. It remains to be seen how the Agencies will react at time of submission for registration. It is easier for mid-size and large size companies to implement missing data by additional satellite studies. Impact for small companies will be major due to refinancing issues and delays for submission."

Increased virtual and decentralised trials

"More flexibility with remote/virtual monitoring at all sites; more flexibility with how patient visits are conducted (on-site vs local physician vs. combo of in-person and virtual)."
"More virtual and decentralised trials, using technology including patient's own smartphones to make it easier for people to take part in research."
"I hope we will see more avenues to accelerate and optimise the regulatory approval process, and more use of 'virtuality' and home-based, patient centric study design in the conduct of clinical trials."

Preventative Measures

"Supply chain and use of medicines in periods of emergency. Formal establishment of more emergency procedures and regulatory pathways for emergencies."
"Hopefully America will finally setup an emergency pandemic funding mechanism and alternative emergency protocols for the FDA and CDC; after their disastrous failures early on. The WHO will likely not receive funding indefinitely. I would like to see a separate non-military federal biodefense apparatus (civilian analog of the DTRA). Separate protocols will likely be instituted as a preconstructed contingency to avoid the bureaucratic blockades that paralysed and prevented early mitigation."
"More guidance in response to pandemic for the development of diagnostics, treatments and vaccines."
"Aware of dangers and putting certain measures in place for fast and effective response."
"Obligation to create stocks of key medical protection devices, gels. Social distancing regulations."
"Regulations regarding preventative safety and development of a new vaccine."
"More employees so reviews can proceed faster."
"More surveillance, mandatory vaccination, digital ID, restriction to free movement."
"Overall sanitation changes."
"Compliance crackdown post outbreak."

"Significant HR changes in the sick policies. This is difficult because the world didn't change - this threat was always there and will always be there. We just woke up to it. The goal would be not to overreact and provide common sense measures. We need massive overhaul of our health care system. Also our digital infrastructure is weak. I think this points to the importance of the internet especially as a utility."
"Manufacturing sites will be required to test employees for COVID-19 infection."

Uncertainty/No Change

"Not enough information yet to know."
"I wish: stronger European integration and coordination. I expect: exactly the opposite: every man for himself (where man = country)."
"I fear the US government will continue to interfere by such irresponsible acts as proclaiming unproven therapeutics are the solution and the pandemic is a hoax. What the government should be doing is have the FDA engage with companies early to provide proactive development guidance and expedited review. Here in the US we should work to rebuild the CDC and our failing public health system."
"No major changes as regulations are appropriate. Laws regarding quarantine, travel and reporting of infectious diseases to be revised."

What are the new challenges and/or changes created by COVID-19 and associated measures are most impacting you at the moment?

Disruption and delays

"The inability to perform laboratory experimentation at will, restrictions disallow optimisation and create major inefficiencies and time delays. Those of us willing to risk exposure should be given that option, I am in the lowest risk category and would most likely suffer minimal effects while being knowledgeable enough not to infect others."
"Ability to monitor safety data is compromised when a site cannot offer remote eMR access, or won't agree to send redacted source. Many sites do not yet have plans in place for how to allow this monitoring."
"Delays in clinical trials, difficult/impossible to meet people face-2-face, clients not knowing the impact on their business."
"Ongoing projects are on hold or delayed. Current Year budgets are being revised to reflect market uncertainty and reduced revenue."
"Pressure to redirect work to deal with COVID 19."

"Inability to get our personnel on-site at our clinical sites to review and monitor study data and compliance; inability of sites to recruit new patients; difficulties in adhering to study protocols with regard to patient visits/patient dosing."
"Halt of ongoing and upcoming projects and limited support from the clients on clearing financial commitments."
"Consulting ecosystem is quite disrupted. R&D programs and initiatives being canceled or indefinitely postpones creates uncertainty and chaos for my consulting business."
"Long-term impacts of financing on pharmaceutical industry; commercial presence; risk of domination of big pharma and loss of innovation from startups and biotechs."
"New business opportunities (pro) but also delays in previous development roadmap."

Changing Work Patterns

"Home working which delays processes."
"Adapting to changed logistics for day-to-day operations."
"More electronic comms, loss of in-person and conferences create delay in forging new relationships"
"Keeping up the mental health – both my own my employees and our collaborators."
"Limited socials contacts, especially with colleagues at work. Balancing between family (kids are at home) and work."
"To run virtual teams is feasible but complex and can only be achieved with ongoing programs and numerous try-and-rescue efforts. To initiate new contacts and activities is slow and financing is a major concern. It certainly is a great opportunity for training."
"We are implementing shift patterns to reduce the numbers on site at any one time which means communication and collaboration is a challenge. Also our external partners are operating under limited situations."
"Opportunity for more trials and research studies to use patient’s own smartphones to take part in research studies."

No Change

"For the moment few changes because we mainly work in field or from home."
"My impact is minimal. I can do my job from home. Getting our organisation to accept digital signature. Small things, in comparison with many other individuals, groups and companies."