The True Cost of Clinical Trial Failure
When we say we have a data management and analytics solution that can improve efficiencies in clinical trials, it sounds rather benign. But clinical trials form the backbone of the medical research that brings to market treatments that prevent death and improve quality of life for millions of people. Inefficiencies in clinical trial management lead to delays, less conclusive results, and even the complete failure of a trial that may have succeeded had it simply been managed more effectively.
Every day that an effective treatment is not available adds to human suffering. From this perspective, improving the efficiency of clinical trials is an extremely worthwhile endeavor. But how worthwhile? In this article, we’ll try to quantify the value of bringing treatments to patients so that we can see what effect improving clinical trials through widespread adoption of a platform like ClinTex CTi would actually have.
A 2010 study by the Manhattan Institute attempted to determine the monetary value to patients of having a treatment available earlier. The study did this using a calculation involving a patient’s willingness to pay, their annual income, and the cost of the treatment. Using that calculation and the HIV/AIDS active antiretroviral treatment (HAART) as an example, the study concluded that a patient being given access to HAART a year earlier than they actually received it would be worth an average of $16,000. To the entire cohort of such patients, the value of one year’s earlier access would be $19 billion. By comparison, the release of HAART one year earlier would have increased the profits of the firm marketing it by $4 billion, or about a fifth of its value to AIDS patients. By this calculation, the monetary value to patients of earlier treatment far exceeds the costs to prescription-drug developers, but in both cases the value is enormous.
Other research attempted to determine the number of life-years potentially lost for each year of delayed cancer treatment approval. Assessing cancer therapies that went through phase 3 trials from 2001 to 2015, the authors multiplied the improvement in median survival (in years) by the estimated number of patients worldwide who die annually from each cancer type. The authors calculated that for each hour of delay in therapy approval there were 29 life-years lost in North America (one for every 2 minutes of delay) and 260 life-years lost worldwide (one for every 14 seconds of delay).
Delays and failure to approve treatments are costly, but considering the potential consequences of an unsafe drug, it is of paramount importance that treatments are safe. Since the Thalidomide disaster of the 1950s, the role of regulatory bodies like the FDA has increased, and for good reason. But as regulations have become more stringent, the cost in terms of time and money to bring treatments to market has steadily increased. The interval between initial clinical testing and product approval has been estimated to average 8 years with only 1 in 6 drugs that enter clinical trials ultimately obtaining approval. This results in the now astronomical average $1.5 billion it costs to bring a drug to market. But many drugs do not receive approval not because they are unsafe or ineffective, but because the information supplied is unsatisfactory to make that determination for regulators.
The bar for drug approval is now set much higher than it once was. This means that approval now requires a much more careful collection and analysis of the data. So while it was once possible to derive sufficient conclusions from evidence presented and analyzed on paper, effective medical research now requires the use of complex databases and, ideally, the assistance of machine learning. This is what ClinTex CTi brings to the table.
To learn more about how ClinTex can transform medicines development, we refer you to the other content in this channel, our website, our whitepaper, and this summary video.
