What Will Clinical Trials Look Like Beyond 2021?

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“Future clinical trials that make full use of digital technologies will look very different at each stage of development – and may have a much higher chance of approval at lower cost.”- ICON Digital Disruption Whitepaper

Article Authors: Gordon Slater|Tandose Sambo 

The COVID-19 pandemic has affected the health and well-being of everyone. As a looming wave of uncertainty, we have all had to adjust to life all while factoring in this situation. For patients who have a chronic medical condition, access to healthcare was actually diverted to some extent, because attention was focused on the influx of patients with the virus. Access to healthcare often puts patients at the risk of contracting COVID-19, while they are admitted for their original health issue. 

COVID-19 has brought about the need for the re-establishment of a disaster management strategy that facilitates the addressing of the root cause of any major health crisis. While this is being conducted however, it will be important for healthcare research to be conducted, that ensures that existing healthcare conditions are being taken care of as well. 

Despite the pandemic, the future of medicine looks bright! The pandemic induced the need for us to focus on digital technology that will achieve medical breakthroughs at an accelerated pace. With the advent of various advances in computer based research, future clinical trials will be increasingly successful. With increasing odds in the pre-clinical phases, the downstream effects will be as desired. The need for solutions to medical problems rests on the advent of Organ-On-A-Chip Technology, Blockchain Technology and Quantum Computing as core technologies used in synchrony with statistical tools and mathematical algorithms, in order to filter through data and generate the appropriate models that represent the desired systems accordingly. 

Technologies such as quantum computing have processed significant amounts of process data in the genomic and proteomic realms and have identified new solutions for various ailments. Such details would have taken conventional computers years to compute. Quantum modelling and the background algorithms enables drug molecule prediction, as well as their mechanisms of action to be clearly identified and predicted. Artificial Intelligence then facilitates determining the best candidates for actual synthesis. AI utilizes algorithms such as empirical physiology models in order to determine how the lock and key mechanism of the drug and its active site will be matched. 

With Organ-On-A-Chip technology, there is a way that organ simulations can be facilitated on silicon chips. With the desired pathways for action able to be simulated in a chemical laboratory, the drugs can then be tested in situ. How the drug will operate in the critical organs can then be determined. In trials, usually the top five drug candidates will be assessed in order to determine the right combination for final drug manufacture. 

With the global nature of industrial and scientific data, global medical records can be assessed by a research entity. With the available data from sources like block chain data, insurance data and electronic health records, clinical trial coordinators can then identify the appropriate candidates for a human trial. 

In a world where data is king, there are several ways that data can be acquired. From a real-time perspective, utilizing real time data generators such as heart monitors linked to an app will be able to facilitate more real-time data that can help researchers identify trends that can assist with improved care. The interesting thing about data, is that the more of it that a research organization collects, the more that human trials can be reduced, in terms of the number of patients to be tested. The ideal candidate can be predicted from preliminary data, and then the actual patients be assessed for site specific reactions to the synthesized test drug. 

Progressing through each stage of the research and development process will be a process that will become seamless with time. With increases in automation, the forecasted success rate for new drug approval will be 60 percent, a six time increase from the current success rate. Drug companies are keen to improve their returns on investment, and look forward to harnessing the best of Industry 4.0 where medical innovation is concerned. Changes in clinical trials will change the entire industry for the best. R&D as a field still has a lot of potential to tap into. From a consulting perspective, the four key advantages for improving the drug development process include: 

  1. Determine the technology needed. In a problem solving methodology frame of mind, an assessment of the existing research system and identifying what operational, IT and AI tools will be needed to optimize the existing operations. Additionally, it will help to identify the current condition for successful product launch. If the current success rate is 6%, what tools will push the organization to 20%. Even a threefold increase will significantly increase the returns. 
  2. Statistical Knowledge – Data is the new oil. Ensure that organization quants are ready and on hand for data processing and model generation. 
  3. Global Network – Data sources and data availability are more valuable with time. Pre-clinical trials will work best if all the pre-work is facilitated. Partnering with global research firms provides the expertise and resources needed to accomplish the task.
  4. Embrace Change – The only thing constant is change! Embrace the fact that new developments are taking place in the field that will help your organization to advance. Early investments will lead to the appropriate outcome in the long term. 

Life continues to evolve despite the COVID-19 pandemic. At best, the existence of the coronavirus is encouraging all of us to be smarter with our health choices. In the research and development realm, technologies that accelerate the rate of drug discovery are being more heavily utilized in order to meet the demands of the global population. 

Resources: 

  1. Trials Journals: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05200-0

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Dr. Gordon Slater

Dr. Slater is one of the first foot and ankle surgeons in Australia to adopt minimally invasive surgical techniques. He routinely uses MIS to treat a range of conditions, including bunions.

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Dr Gordon Slater is a highly-skilled surgeon specialising in foot and ankle conditions and sports injuries. Dr Slater is one of the first foot and ankle surgeons in Australia to adopt minimally invasive surgical techniques. He routinely uses MIS to treat a range of conditions, including bunions. MIS  has many advantages including shorter operating times, reduced post-operative pain, reduced risk of infection, minimal scarring and better cosmetic outcomes.

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