According to industry estimates, the majority of drugs in development will never make it to FDA approval. While a lack of efficacy is often a key factor, many clinical programs are derailed due to avoidable setbacks that can cause delays and significantly increase costs. An effective system able to assess clinical development programs and identify risks at any stage could help reduce costs, streamline the development process and advance more promising therapies to the marketplace. This information could also be important to many audiences including investors and potential targets for licensing or other partnerships.
Unfortunately most companies have neither the time nor the specialized expertise and familiarity with FDA procedures and requirements to undertake this level of analysis on their own. As a result, important details and procedures in many development programs are often overlooked or misunderstood, leading to regulatory penalties, delays or rejections. The availability of a comprehensive third party audit and review system could help companies identify potential risks early in the approval process. Developers could then use this information to address challenges or modify development programs to improve the chances of success.
To be effective, any review of a drug development program should be based on the factors considered in the FDA’s own review process. This requires reviewers to be closely familiar with FDA procedures and standards. For example, our drug rating agency (Claravant Analytics LLC) uses a network of over 75 former FDA officials and industry experts to analyze drug development programs, utilizing specialists in their targeted areas of expertise and therapeutic areas for each analysis. Teams then review a program applying a methodology on over 175 individual criteria, which is designed to comprehensively evaluate the same areas utilized by the FDA when making their own approval decisions. Often these teams can provide important new insights for management teams, boards of directors, investors and others. Following the analysis, the information is then compiled into a report that identifies specific risks and challenges in a development program. Collectively the evaluation provides perspectives on the chances of success in earning regulatory approval.
Reports that identify the full range of risks can be used to help a company take steps to address potential problems or modify a development program in other ways. The results could support a decision to terminate a development program that is shown to have only limited chances of success, or provide important guidance on necessary timelines and costs to address problems and improve their likelihood of reaching the market.
Real Time Information Optimization
Another important consideration in the execution of an independent audit of a development program is the optimization of information in real time. While audits can be conducted at any stage in clinical research, this form of analysis in earlier stage programs may be able to identify problems well before they present significant threats to overall success. Conversely, analysis of later stage clinical development programs can help to safeguard against any last minute challenges or surprises. For this reason companies are encouraged to conduct an audit at every stage of development – from IND through filing – to ensure that these efforts are continually able to identify challenges as programs evolve and expand.
Internal use vs External Use
In many cases, company management will choose to keep the findings from an independent audit confidential and for internal use only. In other cases, though, companies may decide to make the summary results public to provide important insights to investors and investment partners, business collaborators or potential collaborators, and others. These audiences may especially appreciate having high level access to information about a development program that is often not available publicly. Overall this could help to ensure that more investment funding is allocated to development programs with the strongest chances of success and the greatest potential to address unmet needs for patients.
Third-party reviews or ratings of drug development programs may someday become a standard in the marketplace – requested by board members, investors and potential licensees or business partners. In this scenario, a rating would be required much as a rating from Moody’s or Standard & Poor’s is required for credit securities. Banks and other third parties may require a rating as part of their due diligence prior to a public offering or other financing. Drug companies could require a review of a development program before an acquisition.
Rating System Benefits
The ratings process could encourage broader adoption of best practices in drug development programs overall, helping more companies improve quality, streamline development programs and save money. The most important societal benefit of a ratings system, however, could be faster approvals for more important drugs in the years ahead.
