Last month Forbes reported that the cost of a single clinical trial can cost up to $100 million.
One can only imagine the cost of making a mistake somewhere along the way that would require starting again from scratch or, worse yet, making a mistake that prevents the drug from getting FDA approval and entering the market.
Forbes further acknowledged that saving money in drug development could end up causing the developer’s stock prices to increase significantly.
For these reasons it is essential that clinical trials are planned in an effective and efficient method from the very start of the process.
Here are 4 fundamental tips for planning an efficient yet high-quality clinical study from the biostatistics point of view:
- Effective study planning:
A suitable study design may use fewer subjects while providing the same results.
Sample size calculations to ensure sufficient power for demonstrating an effective drug or device.
- Practical endpoint definition:
Straight-forward and intuitive endpoints, easily derived from collected data, save time, money and explaining to investors.
Simple endpoints will be more clear in marketing and avoid regulator confusion.
- Invest in database structure:
A well-planned and well-structured database will be easy to use, both for the current analyses and for future analyses (e.g. post-hoc or cross-study analyses).
Using the FDA-recommended CDISC structure for uniform database structure costs more to build but saves in FDA submissions and meta-analyses.
- Proper CRF design:
A clear Case Report Form (CRF) design can avoid countless mistakes and lead to fewer data queries – this means clear directions, clear questions and clear fields.
An efficient CRF design eliminates redundant data collection, requires fewer pages and educes the size of the database.
Effective statistical planning from the very beginning can ensure passing the
regulatory expectations of the FDA and save money not only in the short-run but also in the long-run.