Creating a new drug is undoubtedly harrowing. The success rate of clinical trials is dependent on many factors such as patient enrollment, efficacy, bureaucracy, and awareness of the general public. These concerns are influential factors that ultimately affect which drugs are put on the market. The life sciences industry continues to be innovative in its quest to cure the world of diseases but must prove itself before being approved by the FDA. Exploring the accomplishments and failures of clinical trials is imperative for the life sciences industry if it wants to progress efficiently through the clinical trials maze. Considering underlying factors in both clinical trial failures and successes is both essential and pragmatic for clinical trial professionals .
COMMON CHALLENGES
Patient Awareness and Retention-
Clinical trials aren’t possible without trial participants which means that working with clinics and hospitals to cultivate awareness is vital to the process. The public is less likely to engage in something it is not aware of or does not understand. Education and literacy around the importance of clinical trials should be emphasized and discussed more. The general public is greatly unaware of the importance of clinical trials and the role trial participants play in ultimately healing and saving lives.
Trial Complexity-
The study design is a core issue that impedes probability of success. Research conducted by Andrew Burrows of Clinical Trials Innovation sited the complexity of trials as a significant issue for clinical trials professionals. Life sciences companies need professionals who understand the complexities of designing studies that are compliant, results-oriented, and also feasible for trial participants.
Costs-
Biotech companies ability to control costs can also lead to clinical trial failure. The current results of the Tufts Center for the Study of Drug Development assessment indicate $2.6bn as the average cost of reaching marketing approval. Attempts to control costs include developing biomarkers and improving both project management and the aforementioned patient recruitment and retention. Each failed trial costs not only time and energy but the investor’s belief in a company’s ability to perform. This can result in reduced market share and ultimately funding for upcoming clinical trials.
SUCCESS FACTORS
It’s important to note what’s been learned from clinical trial failures to understand what’s needed to succeed. In spite of the arduousness of clinical trials, 13.8% of drug development companies make it from phase 1 to testing approval. Surviving phase 3 and ultimately proving efficacy is a good indicator of advancement. A well-defined roadmap that secures the completion of phases 1 to 3 includes having a team that can effectively manage the inherent difficulties of clinical trials. Oxford Academics 2018 findings also state, “trials that use biomarkers in patient-selection have higher overall success probabilities than trials without biomarkers.” The life sciences industry continues to forge ahead by innovating and finding solutions to the world’s health problems. Clinical trials are arduous, but not impossible. The data collected from each clinical trial failure can ultimately be learned from and used to garner more momentum for biotech companies.
HOW RUBIX CAN HELP
It’s just as important to not only have intimate knowledge about how the clinical trial process works, but how you can also be effective in increasing success toward reaching your endpoints even before entering Phase I trials. It’s paramount to have a team that can see the early warning signs to navigate your team away from crashing. Rubix LS can augment your team in many ways to be able to assist with project execution and make overcoming challenges just another Tuesday. From understanding the clinical trial databanks to scientific articulation and study management, Rubix knows where your pain points are and how to overcome them.