In an industry that typically takes 10 to 15 years to gain approvals, getting to a Covid-19 vaccine in mere months was no small accomplishment. This journey was unusual, requiring the entire industry to come together in unprecedented and urgent ways.
While the pandemic temporarily disrupted trials, the lessons learned during the pandemic can be applied when trials resume. We are at a critical juncture, from which there is #NoGoingBack. As an industry, we need to maintain momentum, strengthen future partnerships, and apply learnings to optimize future clinical trials and accelerate the drug development process.
While other industries move forward with digital transformation and data-enabled technologies, clinical drug development has struggled to see consistent progress in these areas. As we improve upon recent advancements, the way forward is to create and repeat sustainable processes. This includes leveraging modern technology to power scientific discoveries, taking a data-first approach to implement patient-centric and decentralized trials, and enabling the development of personalized medicine.
Here are three key strategies that can lead us through this new era in clinical development.
#1. Collaboration and Partnerships
In order to improve trial efficiencies, speed, safety, and efficacy, many of the successful Covid-19 vaccines came from unconventional collaborations. For example, the partnerships that emerged between academic institutions, biopharma companies, and startups were instrumental in developing the Covid-19 vaccines in record time. This was due to their ability to combine resources and knowledge. With governments, regulatory bodies, and the public supporting the common goal of accelerating timelines, clinical researchers were able to complete trials without common barriers. This single vision across the industry offered opportunities to cooperate and collaborate, and this mindset will be critical to drive incredible results in the future.
After the pandemic, data transparency, both between organizations and to patients, will be critical to maintaining momentum. This will help patients take an active involvement in their care, as data and results can be ready almost instantly. With greater collaboration between governments, healthcare, and the biopharmaceutical and medical device industries, we will also see significant advancements for other therapies. We need to be prepared for future global health events, as well as allow for quicker development of treatments and medicines, which can be achieved with increased collaboration and partnerships.
#2. Modern Infrastructures and Data Strategy
Between increased data sources and decentralized trials, the pandemic paved the way for digital transformation and modernization. The successes we’ve seen mean that these trends are here to stay. However, they require suitable investments and support to drive value and outcomes.
Decentralized trial approaches and the use of wearables, genomics, and other methods to gain real-time patient data streams have created a proliferation of data. Although data is crucial for drug development, personalized medicine, and clinical research and development, it also impedes timelines. Over the last three years, increased data sources have contributed to a 40 percent increase in Last Patient Last Visit (LPLV) to database lock. Clinical trials need to adopt modern data management strategies to provide greater visibility into new sources.
Life sciences organizations are looking to integrate data management processes sooner into their clinical trials to improve data collection, analytics, and submissions. With a robust data infrastructure in place, processes can be automated, and manual efforts can be reduced. This increases data scientists’ ability to spend time driving meaningful results. It also helps prepare organizations for new technologies such as AI and machine learning, helping transform data streams into actionable results.
Effective data management also helps ensure data quality, minimize risks, and prepare for advanced analytics. This accelerates timelines by improving approval processes. With huge increases in data sources, clinical data platforms allow organizations to review and synthesize data quickly, resulting in faster time to market for new drugs and therapies.
#3. Technology Upskilling
In order to navigate this new environment, life sciences leaders must support their teams and foster new skills. As digital transformation becomes a strategic imperative across the industry, clinical leaders and their teams need a deep understanding of how to maximize the usage of new technologies and solutions to achieve the best results. They also need to leverage individuals who are comfortable with these new digital tools, relying on them to drive adoption and efficiency.
New roles are emerging in the life sciences industry, and organizations must understand how to develop and evolve them for their own teams. Traditionally, data managers and statisticians employed manual techniques to collect, clean and analyze data. With new technologies supplemented by AI and machine learning, many repeatable, time-consuming processes can be automated, allowing clinicians and data managers to use their skills effectively for other critical functions.
These technologies also allow for deeper insights from analytics, which will create needs for new roles, such as data scientists. This can help evolve data and analytics capabilities to predict outcomes, increase accuracy and accelerate timelines.
Looking Beyond #NoGoingBack
The Covid-19 pandemic necessitated serious changes in the life sciences and clinical development industry. It has allowed us the opportunity to leverage technology, data, and partnerships to accelerate timelines without compromising quality or regulatory guidelines.
As we emerge from the pandemic, it is important to maintain this momentum for other drugs and therapies. With wearables, personal devices, longitudinal data, and other sources, we have more data than ever before. With collaborative efforts, modern technology infrastructures, and decentralized and patient-centric trial models, we can achieve groundbreaking outcomes.
About the Author:
Chief Marketing Officer, eClinical Solutions
Sheila Rocchio is the Chief Marketing Officer of eClinical Solutions and the company’s marketing and product management functions. She enjoys hearing and telling customer stories and building products and services that help clinicians, data scientists, and technologists do the challenging and important work of bringing new therapies to market.