By Exploristics CDSO, Kim Hacquoil
For many years the car industry has been improving the safety of the cars it builds through rigorous testing using crash test dummies. Data collected from these dummies have led to the inclusion of key safety features such as seat belts and air bags which are now fitted to all vehicles and have saved hundreds of thousands of lives. However, while crash test dummies are still used for this purpose the car industry has been successful in embracing other technological advances to identify potential problems and find solutions to these earlier in the design process.
Car manufacturers use computer models and simulations to optimise designs so by the time a prototype vehicle is built for testing with dummies, many risks have already been identified and mitigated for. Simulation at this early stage has driven time and cost-saving by:
- Removing guesswork to achieve rapid innovation.
- Accelerating workflows to facilitate more choices.
- Optimising products for rapid development.
Can Pharma learn anything from car manufacturing?
The Pharma industry faces many similar challenges to the car industry in bringing a new product to market. Clinical development is also costly in terms of time and money, and new medicines must be rigorously tested for safety and efficacy over the course of multiple phases of clinical trials. However, there are no crash test dummies here. Clinical trials require the recruitment of large numbers of people who are clinically suitable, willing and able to participate. Yet as an industry, do we really do enough at the design stage to ensure that we are reducing the burden of these trials? Given the multiple costs and complexities of running a trial, can we harness simulation more widely to identify problems with clinical trial design and mitigate for these before running the real study?
A more strategic approach to drug development
Using modelling and simulation technologies offers a more strategic approach to clinical development. At the planning stages of a clinical trial, it can help align study design and analysis with the clinical question being asked and the real-life situation faced in the clinic. It allows for risks to be quantified and mitigated for before anyone receives treatment. In short, it puts the needs of patients first by ensuring that when they participate in a clinical trial, we have done everything possible to optimise its design first.
Adding simulation to your development hand
It is unlikely that the car industry will fully remove the use of crash test dummies as they still provide valuable data that helps to ensure passenger safety. Similarly, clinical trials will probably remain the gold standard for rigorously testing the safety and efficacy of new medicines. However, there is room to learn lessons from car manufacturing and build in earlier de-risking interventions like simulation. This will this ensure that the valuable input of patients in clinical trials is used more effectively in a well-designed study that is more likely to succeed. The increased use of modelling and simulation also has the potential to dramatically reduce the number of clinical trials and/or number of patients in clinical trials for regulators to approve a treatment, addressing common industry pain points like recruitment. Embracing simulation more widely in the development process does not mean discarding standard approaches like clinical trials. It means adding more options to your development hand for greater success.