Prediction: Investigator-Initiated Studies (IIS) to Increase as Drug Development Pipeline Dramatically Changes

This is the sevent installment in the series (Change is in the Air) on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, LLC,  began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”

Prediction 7: The drug development pipeline will change dramatically, and we will see an increase in Investigator Initiated Studies (IIS).


John Neal, CEO of PCRS Network, LLC

To some extent, this prediction could be inferred from my fifth and sixth predictions. But I believe the changes will run deeper than simply a shift away from major diseases like diabetes and hepatitis C. With effective treatments available for those diseases, and continuing advances in oncology leading to decreasing mortality rates for many types of cancer, research and development funds will become increasingly available for a broad range of diseases. Additionally, advances in technologies will make it possible to study many diseases in ways that simply were not possible previously.

When I spoke recently with Jamie Macdonald, CEO of INC Research on the topic, he stated, “You are going to see ongoing research in oncology, and some of the areas where there has not been enough progress like urology, Parkinson’s, Alzheimer’s, and some of the motor neuron diseases as well. The science will lead us to continue that work.”

“KOL input is important, because they are leading the academic science, but operation input from Investigators that are very hands on from a clinical standpoint is necessary.” Jamie Macdonald, CEO of INC Research

With increased emphasis on more specialized and rarer diseases, I believe we will begin to see an increase in IIS, as individual doctors or groups identify opportunities to make progress in areas that, to date, may not have been economically desirable or feasible for pharmaceutical companies to pursue. The opportunities to study diseases that impact smaller populations, but that could provide major benefit to those populations are nearly endless.

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