Josh Rose, the Vice President of Enterprise Offering Development shared perspective on how small and midsized biotechs can get the most out of their clinical trials after securing investment.
A few factors to consider include:
- - The data and technology being leveraged to optimized the clinical planning and protocol well before the trail begins.
- - On a global basis, what are sites – do they have capacity to match your needs?
- - Do they have the right markets? Another key for data usage is to figure out if your patients are there.
- - Consider cost at the site level. Line item cost have a significant impact on the cost of the trial. These things can lead to great savings. With this knowledge from data you can save.
- Utilities of adaptive trail design: There are so many great technologies that have a big impact in improving probability of success. Examples include:
- 1) Adaptive dosing: Find the optimal dose
- 2) Sample re-estimating: Find arms that aren’t as beneficial – terminate those
- 3) Sample enrichment – Modify trial to move patients towards promising areas
- 4) Adaptive biomarker strategy: You may have 5 biomarkers that you think are benefitial but what is really working?
- Benefits of this strategy include: Early termination if the trial is not producing results, testing for the optimal dose, identifying and narrowing in on the correct sample size
- Risk based monitoring: Changing the way data is used by the sponsors
- Only a small percentage – 2% – of data is incorrect after being collected. RBM would allow trial sponsors to rethink data collection.
- - Sponsors could identify risks and develop a plan to only look at data where the risk is. Real time monitoring of trial and look for red flags in data t respond to in real time. Move from data varificaiton to lower levels. This drives 25% reduction in cost on average – quality also improves.
- - Potential drawback to effectivly using this applicaiton in clinical trials include the right mindset, tools and methodology at the beginning are critical.
Christoph Schnorr, the Vice President of Drug Development Consulting in Europe briefly discussed integrating payor perspectives. It's important to understand that delivering the best treatment options to patients also means understanding the needs of stakeholders across the entire clinical trial chain - including payors. Increasing the value of the asset means thinking about physicians and patients. Integrate those persepctives in the product development model and how data ans aspects of the trial can generate the evidence needed to promote these goals. He also pointed out that treatment paradigms are changing quickly. It’s extremely important to know what compounds are coming to the market so a company prepare for and understand the design and landscape of the field when molecules are scheduled to hit the market.