The recent global pandemic has brought to light the critical importance of clinical trials in the development and approval of vaccines and treatments. As the world recovers and looks towards the future, there is a pressing question: Can we avoid another pandemic through improved clinical trials?
Sasidhar Duggineni is the compliance manager at a global leading clinical research firm. As an industry insider, Duggineni says that those within the life science field must keep up with emerging technology to transform patient care, enhance quality of life, and ultimately save lives - potentially avoiding another worldwide crisis like the COVID-19 pandemic.
“I’ve been in this business for over 12 years,” says Duggineni. “I’ve seen so much change during that time, and I have learned over and over that you have to push boundaries. My goal is to change the way clinical trials are conducted and leave a lasting imprint on the field with the hopes that something like COVID-19 doesn’t take us by surprise again.”
He emphasizes the importance of his data integrity as a code framework (DIAC) for clinical trial systems in preventing and responding to future health crises, and says that challenges faced in the current system can be overcome by innovative approaches being taken to enhance the efficiency, speed, and effectiveness of clinical trials. “As we examine the potential of advanced technologies, streamlined processes, and collaborative efforts, we can gain insights into how clinical trials can contribute to a more resilient and prepared healthcare ecosystem, ultimately protecting global health and preventing future pandemics,” Duggineni states.
The traditional clinical trial system is often characterized by lengthy timelines, bureaucratic processes, and regulatory hurdles. These factors can delay the development and deployment of critical interventions during a public health crisis, limiting our ability to respond effectively.
Also, clinical trials often suffer from a lack of diversity among participants, which can impact the generalizability and applicability of the findings. To ensure that interventions are effective across different populations, it is vital to address barriers to participation and ensure a more inclusive representation of diverse communities.
“A third issue is inefficient data collection and analysis,” says Duggineni. “Manual data collection processes and fragmented data management systems can hinder the timely analysis and interpretation of trial results. Adopting my data integrity as code (DIaC) framework can significantly bend the time curve and facilitate faster critical decision-making.”
Stringent regulatory requirements and lengthy approval processes can impede the rapid development and deployment of interventions during a pandemic. Balancing the need for safety and efficacy with the urgency of public health emergencies is essential to ensure timely access to life-saving treatments.
“We need to normalize utilizing advanced technologies for faster and more accurate data collection,” Duggineni explains. “Incorporating technologies such as wearable devices, remote monitoring, and digital health platforms can enable real-time data collection, leading to more comprehensive and accurate insights. This allows researchers to make informed decisions promptly and adapt trial protocols as needed.”
He also says that implementing adaptive trial designs can optimize efficiency and flexibility. Adaptive trial designs offer the ability to modify trial parameters based on emerging data, allowing for quicker identification of effective interventions. These designs enable researchers to make necessary adjustments during the trial, leading to more efficient and cost-effective outcomes.
“I also believe in promoting diversity and inclusivity in participant recruitment,” says Duggineni. “Enhancing efforts to recruit a diverse range of participants ensures that trial results are applicable to different populations. Addressing barriers to participation, including language barriers, socioeconomic factors, and cultural sensitivities, can help improve representation and enhance the generalizability of trial findings.”
Lastly, he recommends strengthening collaboration and data sharing among researchers and organizations. Increased collaboration, both domestically and internationally, can foster the sharing of data, resources, and expertise. The creation of networks and platforms for collaboration lets researchers leverage collective knowledge and accelerate the development of interventions, leading to more effective pandemic prevention strategies.
“Streamlining clinical trial processes and incorporating innovative approaches can expedite the development and approval of vaccines and treatments,” Duggineni shares. “This enables a faster response to emerging infectious diseases and reduces the impact of future pandemics.”
He also points out the value of enhancing surveillance and early detection of infectious diseases. Improved clinical trial methodologies can contribute to early detection and monitoring of emerging infectious diseases. By integrating surveillance systems into clinical trials, researchers can identify patterns and trends, enabling proactive public health responses.
“It’s also important to improve health responses and preparedness,” Duggineni emphasizes. “Robust clinical trial infrastructure and efficient trial processes empower public health organizations to respond swiftly and effectively to public health emergencies. Insights gained from clinical trials can inform evidence-based policies and strategies, leading to better preparedness and response capabilities.”
Lastly, he recommends the facilitation of global cooperation and knowledge sharing in pandemic prevention. Collaborative clinical trials foster international cooperation, enabling the sharing of data, resources, and expertise. By aligning efforts across borders, we can harness collective knowledge to develop comprehensive and globally applicable interventions to prevent future pandemics.
So, in a nutshell, yes - improved clinical trials have the potential to play a pivotal role in preventing another devastating pandemic.
“As we address the challenges within the current clinical trial system and embrace innovative approaches, we can enhance the efficiency, speed, and effectiveness of clinical trials,” Duggineni says. “This, in turn, will enable the development of life-saving interventions, enhance public health responses, and promote global collaboration in pandemic prevention efforts.”
As we navigate the post-pandemic era, investing in innovative clinical trial methodologies and fostering a resilient healthcare ecosystem is crucial to safeguarding public health and preventing future health crises.
Sasidhar Duggineni is a renowned professional and researcher in the life science industry, with a career spanning over 12 years. With extensive experience in clinical research organizations and big pharma companies, he has made significant research contributions to the field, particularly in clinical data integrity and healthcare IT compliance. His expertise has been recognized by reputable journals, and he has played a crucial role in supporting the success of COVID-19 vaccine trials and advancing medical research for federal government agencies like NIH and DOD. He currently serves as the Compliance Manager at a leading clinical research organization.
Learn more: https://www.linkedin.com/in/sduggineni/
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