The pharmaceutical industry faces a unique set of challenges to productivity, according to 3 Pillars Global. These include increased government oversight, loss of revenue due to the expiration of valuable patents, and an increased demand for generic medications. On top of that, the growing complexity of medicine and advances in biotechnology mean that communicating the scientific story of any one drug becomes more difficult. Because of these pressures, the industry needs to look for creative ways to enhance their research and development (R&D) and Medical Affairs efforts. Below are some ways historical data can provide great value pharmaceutical companies.
Reduce Errors in Clinical Trials
Clinical trials do not take place “in a vacuum,” according to an article in the journal Pharmaceutical Statistics. Previous clinical trials on the same medication, if those trials were sufficiently similar to proposed new trials, can provide important control information, allowing companies to dedicate more resources to new research on the treatment in question. Thus, historical data can help to make clinical trials more efficient and reduce both errors and redundant research. Clinical Trials also notes that this historical data not only can be useful for the design of new trials, but also for their analysis, where it can be summarized to provide a background for new research. So, historical data is also important because it forms a context for more recent investigations.
Aid in Determining Anomalies
Out-of-trend data can present a conundrum for the pharmaceutical industry, reports an article on the Pharm Tech website. Because recognizing these clinical anomalies can be useful but remember that this requires a significant amount of historical data for it to be useful in alerting pharmaceutical companies to unusual data results. From a Medical Affairs point of view, this can help to separate the anomalous from the truly valuable data and to discern misinformation about a drug that might be based on scanty or incomplete evidence.
Support a Continuum of Drug Discovery Knowledge
One perennial challenge to pharmaceutical companies regarding drug development is efficiency and continuity of knowledge when it comes to the drug development process. Part of this problem stems from the fact that available data is taken from several disparate sources, such as universities and biotech firms, who are important stakeholders. Having access to past information that has been developed on a drug makes it possible to form a continuum of timely, valuable knowledge about a medicine or treatment that can give companies the information they need to efficiently bring a product to market. It becomes imperative then, to centralize this information, standardize it and make it available across the entire organization.
Provide Information for Benchmark Analysis
One of the most important — and often overlooked — uses of historical data is for benchmark analysis. Robert Olszewski, a CPA with Kreishner Miller notes that in order to have the kind of full understanding needed for accurate forecasts and to measure performance against competitors in the same industry, historical data must be used. Scientific dissemination data can help Medical Affairs teams assess themselves against the performance of their competitors with information, for instance, on the meetings and journals where data was published, who was publishing and how much data was disseminated during a similar or competitive drug launch. With this knowledge, a company can more accurately measure against the success and failure of others and continually improve their own performance.
For all these reasons, pharmaceutical companies should strive to make use of the large amounts of historical clinical data that are available to them as a way of enhancing their R&D and Medical Affairs capacities and helping to mitigate the challenges currently facing the industry.