Clinical studies: 7 tips to maximize your resources and enable more efficient projects
We often get in touch with promising drug ideas that could make a big contribution to our company's portfolio. However, knowing that an innovative idea has less than 10% chance of becoming a registered medicine is a discouraging fact. In this context, the cost of clinical studies is one of the main factors that weigh in this equation - since they are the longest and most expensive stage in the development of innovative or incremental products.
But how can we make a good product idea more efficient and economical? Thus, we bring here some viable recommendations previously used, and selected from scientific publications in the area:
Do not accumulate functions in the area of Research and Development that are not efficient, for this there are potential partners able to perform the function more quickly and more economically, as are the CRO (Contract Research Organizations), whether in the area of clinical research or not. This reason led many multinational pharmaceutical companies to completely outsource their clinical research teams, keeping only strategic coordinators in the area internally.
Be agile when looking for answers that make your project unfeasible and do not save energy to discover the weak or critical points of the product under construction. In this way, the company can immediately discard failed projects and invest time in potential winners.
Invest in computer simulation data modeling. From scenarios built with data already available for your product, make computer simulations feasible in order to predict possible clinical results. Studies with healthy patients or even volunteers are too expensive to obtain unfavorable and surprising unexpected results.
Do not select partners for price alone. Weak partners, be they inexperienced companies or research centers, in general, can be cheap and bring more problems. In the end, the result may be equal to or more expensive than less accessible options.
Always look for models of simple, short studies that bring concrete answers, if possible. There are companies investing in adaptive clinical studies and partial efficacy assessments, as a conditional to proceed with the project. It no longer makes sense to conduct a study for 5 years, for example, and discover that the result is not positive.
Invest in building efficient and cohesive teams, and preferably using project management methodologies. Fragmented and inefficient teams, even if composed of highly trained people, are generally not able to successfully carry out complex projects.
Manage the product life cycle efficiently by eliminating barriers between research, marketing and factory teams. Many promising projects die simply because of the lack of fluidity between these teams in the company.
These were some guidelines identified as contributing to the success of pharmaceutical projects, whether these drugs or health products, previously identified as effective for building a successful portfolio and summarized here in a succinct way.
And we wish you success in making your projects feasible!
Goldman, M. The Innovative Medicines Initiative: A European Response to the Innovation Challenge. Nature, 91, 418-425, 2012.
Kaitin, K.I. Translational research and the evolving landscape for biomedical innovation. J Investig Med, 60 (7), 992-998, 2012.
Silva, CR. Desenvolvimento de medicamentos no Brasil: evolução e cenário atual. Editora Nelpa 2017, 2ª edição.