While the pandemic has been incredibly disruptive to the economy and to the day-to-day life of every individual, how ill the pandemic impact biostatistics? Certainly the development of the Pfizer and Moderna mRNA vaccines utilizing CRISPR technology was a significant advance in the speed of development and efficacy as compared to almost any vaccine in history. Robert T. O’Neill in an article in ScienceDirect.com shares how prior crises dramatically impacted biostatistics with an expectation that the COVID-19 pandemic will advance the practice of biostatistics as well.
The AIDS Crisis
O’Neill relates that once the drug AZT was approved a new regulatory process was created called “accelerated approval on the basis of a surrogate endpoint.” This effort stimulated public discussions at the FDA’s advisory committees on study designs, clinical endpoints, combination therapies, optimal doses of treatments to minimize toxicity, emphasis on viral load as an endpoint and the evaluation of mother to child transmission and the use of anti-virals to protect the child to name just a few. This reaction to the AIDS crisis changed the way biostatisticians approached their work.
Large Scale Clinical Safety Studies
In the past decade a series of public health safety issues that came from adverse drug events associated with newly marketed drugs were widely publicized. In response the U.S. Congress passed new laws requiring pharmaceutical companies to conduct clinical safety studies pre-marketing as well as post-marketing to better assess and quantify risks of adverse events associated with new drugs. This new era in the science of safety assessment of new drugs required substantial biostatistical and epidemiologic expertise devoted to large outcome clinical trials designed to evaluate risk, and an increased investment in methods and approaches for observational data from electronic medical records, claims data and other health plan data sources.
ICH – International Conference on Harmonization
This change didn’t develop from a crisis but from multiple countries recognizing that it was time to develop more consensus on common standards for drug and biologics development research so that duplication and the cost of duplication would be eliminated and patients anywhere would benefit from new drugs and biologics regardless of where clinical studies were conducted. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a conference in Brussels. In 2015 the ICH was expanded further to include more countries and regions and became a legal entity and non-profit in Switzerland. The U.S. already had the Sentinel System that provided a national network of experts who adhere to common data models that allow pooling of data throughout the U.S., but the ICH created an infrastructure for the global community to collaborate. Certainly the sharing of the coronavirus genome by the Chinese early on was one of the first ways there was pandemic impact biostatistics.
The pandemic will continue to impact biostatistics in significant ways. Interested in a career in this field? Contact Smith Hanley Associates Biostatistics and Medical Affairs Executive Recruiter, Nihar Parikh at [email protected].