Fail Early in Clinical Development if You Want to Succeed

Andrea Charles

If you are going to fail, it is better to fail earlier. All phases of clinical research are striving to reduce attrition, streamline their processes and develop drugs cost-effectively. Identification of which drugs are likely to fail at an early stage is paramount for product success across the innovation chain.

Speaking to Pharma IQ in a recent interview Dr James Dow, Director of Clinical Pharmacology & DMPK, (OSI) Prosidion said “ I think attrition will always be an issue, reducing attrition clearly involves choosing the most appropriate compounds for phase I studies. However, I think that it is equally important to make sure that attrition takes place as early as possible in the development process, where costs are relatively low, rather than at a later stage where development costs can be extremely high”.

So what are the top five strategies being implemented in early clinical development:

  • Better cross-functional cooperation

Communication is key factor for developing a new drug product. As a result, strategic management is currently implementing best practices and processes to improve cross-functional cooperation between teams. Cross-functional cooperation has been found to be a strong predictor of certain project outcomes especially in a R&D setting, and leads to more informed investigations and reduced safety risks. Greater emphasis is also being placed on understanding the importance of preclinical studies for clinical success, and facilitating the transition between preclinical studies and phase I trials through a coordinated approach.

  • Application of biomarkers in early development

Biomarker strategies are currently being employed to improve the development of drugs in the early clinical phases. Efficient design of biomarker studies enables faster go / no-go decisions to be made through informative decision making, and the application of biomarkers in phase I can improve translatability between phase II trials, ultimately speeding time to market.

  • Optimising the CRO selection process

The decision to outsource, is not one to be made lightly, and if made incorrectly can be time- consuming and very expensive. More pharmaceutical companies are developing their critical criteria for success earlier, to ensure the CROs they identify as potential partners meet their desired criteria. Site visits in the early stages, to get a “look and feel” of how a facility runs, have been shown to decrease future workload and dissatisfaction within the working relationship.

  • Use of patient populations in phase I

In some therapeutic areas, the use of patient populations in early clinical development has led to a greater understanding of drug viability in Phase I. Being able to define when and how to use patient populations in phase I can reduce cost, as it allows for early decision making. One of the main challenges faced by clinical research teams using patients in phase I, is optimising patient recruitment, and acquiring a suitable patient network. Many have had to turn to CROs who have huge patient numbers in their databases, and have identified this business need.  

  • Effective clinical supply and management

The clinical trial supply environment is very complex, with many players working together to ensure the right drugs are delivered at the right time. Phase I materials are of huge value in research terms, and pharmaceutical companies need to ensure their suppliers and distributers offer a secure and efficient service. To streamline their clinical trials many companies are investing heavily in effective clinical supply management. Analysing the clinical supply chain before the start of clinical trial, and choosing the right providers will have a major impact on the desired trial outcome and the length of the trial.

The clinical development stage is the longest and most expensive in the drug development lifecycle. Expediting the process by reducing attrition, and making informed decisions in the early phases, is crucial if pharmaceutical research and manufacturers are to catch the next big blockbuster.