The Covid pandemic changed the face of clinical trials. With the global pandemic unfolding at pace, the goal to get treatments approved as quickly as possible meant fast-paced study start-ups and trial flexibility at speed. This urgency to bring effective therapies to patients as quickly as possible set new expectations for infectious disease trials and vaccine development, for speed, agility, and operational excellence.
Infectious diseases
Infectious diseases are illnesses caused by harmful pathogens which get into your body, which can include bacteria or viruses. In 2019, around 7.7 million deaths were associated with 33 common bacterial pathogens, approximately 13.6% of all global deaths for that year. During the Covid pandemic, upwards of 3 million deaths were thought to be caused by the virus. Given the high rates of mortality linked to infectious diseases, it is no surprise that they are the focus of many large-scale global clinical trials. Pharmaceutical companies, sponsors, and healthcare professionals continue to prioritise the development of innovative, effective treatments and vaccines to combat both emerging and well-established infectious pathogens.
The unique demands of infectious disease trials
Infectious disease trials come with a unique set of challenges. Understanding the pathogen, its transmission, and its impact on varying populations can be complex and unpredictable. The novelty of the pathogen under consideration can cause difficulties in establishing an effective treatment or vaccine due to lack of pre-existing research, something that is becoming increasingly common in the face of widespread antimicrobial resistance and pathogen evolution.
Other factors influencing infectious disease trials include:
- Rapid recruitment and enrolment
- Seasonal recruitment
- Short screening period
- Complex randomization and dosing schedules
- Evolving trial protocols as an understanding of the pathogen develops
- Adaptive trial designs
- High participant volume
- Evolving pathogens amid antimicrobial resistance
- Potential modifications to trial design and treatment regime
- Benefit-risk balance for participants
- Resource-limited settings
Lessons from Covid
The Covid pandemic highlighted the urgency and time sensitivity associated with infectious disease research, demanding speed, accuracy, and flexibility under emergency conditions. The development of effective vaccines was critical to global public health, which made it a key priority for governments, researchers, and pharmaceutical industries. All clinical trial activities during Covid were expedited, with less time to spend on study start-up. Time needed to be used very carefully. This urgency resulted in accelerated study timelines, adaptable research designs, and emergency approvals.
“The criticality of the COVID-19 pandemic saw the emergence of fast-paced study start-ups, with the goal to get treatments approved as quickly as possible,” says Patricia Rayner, associate director of account management at Perceptive, who supported the fast IRT build for the trial.
More than three years later, some of the changes introduced during the global pandemic remain, including streamlined trial procedures, faster study start-ups, adaptive trial designs, alternative methods of supporting trial participants, enhanced collaboration between countries and organizations, and the ongoing integration of digital technologies.
The role of IRT in fast, compliant, global research
Interactive response technology (IRT) played a key role in helping clinical trials run smoothly under the pressure of the global pandemic. IRT is a system used in clinical trials to automate and manage various logistical aspects of study operations. IRT delivers a wide range of features, from randomization and blind protection to trial supply management and allowing you to gather vital insights and data with speed and accuracy.
Covid became a catalyst for fast adaption and clinical innovation. Innovative digital technologies took centre stage, enabling researchers to maintain accuracy, efficiency, and scalability, supporting the remote treatment and monitoring of global trial participants, and allowing for faster decision-making and rapid vaccine development.
Reliable IRT delivered quickly
With what can only be described as seamless delivery under unprecedented conditions, Perceptive eClinical’s IRT team rose to the emergency, building multiple IRT systems in less than two weeks, the shortest of which was delivered in under 6 days.
Protocols were being finalized concurrently with IRT system design, requiring rapid system adaptations to get systems up and running as soon as possible. Quality was maintained regardless of the drastically shortened delivery timelines, and IRT systems were delivered with focus and speed, helping sponsors to bring vaccines and treatments to patients suffering from Covid.
Post-pandemic expectations
Clinical trials post-Covid call for the ability to flex and adapt. What was once impossible is now considered essential, meaning the demand for fast, reliable, and scalable clinical trial solutions has reached an all-time high. Sponsors require partners who deliver under pressure, with eClinical solutions that enable faster, smarter trial execution.
With a proven delivery record in unprecedented conditions, Perceptive can be considered a trusted partner for infectious disease research, providing efficient IRT technology driven by expertise.
Learn more about Perceptive eClinical today, or contact an eClinical solutions specialist.
Tim Fawnshaw, a psychology graduate from the University of Hertfordshire, has a keen interest in the fields of mental health, wellness, and lifestyle.
