Meet SRG’s Orange Paper USA!

Igor Stefanov
CEO @ SRG CRO & A Kingsman @ ACROSS Global™

I’m pleased to introduce to you the new edition of our Orange Paper analysing clinical trials in the USA during Q3 2018. Meet the new USA member of SRG’s Orange Paper family!

Worldwide Trials Up 19%

According to, 6,396 new clinical trials of all types were initiated worldwide during Q3 2018, including local and bioequivalence studies. There were 2,076 studies approved in the USA and 1,615 trials were approved in 17 leading European countries. This translates to worldwide overall year on year growth rates of 19% worldwide, 8% in the USA and a 23% decline in 17 leading European countries by number of studies (we set a threshold of as minimum 20 Clinical trials conducted in Q3 2018 as including criteria for European countries).

PoC Studies at the Top of the Heap

Interventional clinical trials are the dominant type of research with 82% market share worldwide, 90% in the USA and 82% in Europe. The most prevalent phase of clinical trials conducted worldwide by number of studies was Phase II.

1.2 Million Patients

The worldwide population of patients enrolled in clinical trials of all types in Q3 2018 reached 1.2 million people; about one half of them are enrolled in in interventional trials with an identified study phase (I – IV). The majority of the patients are enrolled in Phase III trials, and the largest growth in global patient population was in Europe. However, the share of patients participating in clinical trials remains extremely low in comparison with the overall size of population – approximately 0,02% Worldwide, 0,05% in the USA, 0,07% in leading European countries and 0,01% in Russia. The most prevalent therapeutic areas of Clinical trials were Oncology and Cardiology.

Top Ten Sponsors

In the USA the top-ten sponsors account for only 7% of total number of studies conducted in USA during this quarter although they account for 23% of all patients enrolled in these trials. Top sponsors in Q3 2018 were: AbbVie, Hoffmann-La Roche, Merck, Pfizer, Janssen, Bristol-Myers Squibb, AstraZeneca, Eli Lilly, Incyte Corporation and Novo Nordisk.

In comparison, in Russia the ten largest pharmaceutical companies combined account for 29% of all clinical trials by number of studies and 49% of patients enrolled in these studies.

FDA Approvals

During Q3 2018 the Center for Drug Evaluation and Research (CDER) of the FDA approved 13 new drugs; four of them were new molecular entities (NME); other approvals concerned various improvements in existing pharmaceutical products. Four of these 13 drugs were tested in clinical trials involving Russian sites.

EMA Approvals

In the same quarter the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) evaluated 21 new drugs. One drug was withdrawn, 20 drugs received positive opinions and were approved to marketing. Twelve of the 21 new drugs were tested in clinical trials involving Russian sites.

FDA Inspections

According to the FDA data, 2 FDA inspections were conducted at U.S. investigative sites during Q3 of 2018 year; there were no FDA inspections conducted at Russian investigative sites whilst 2 FDA inspections were conducted in investigative sites located in the Czech Republic.

Top Tech Trends in Q3 2018

Three top tech trends in the Pharmaceuticals industry in Q3 2018 were:

Improving quality of Patient Relationship with patient-faced services like Medication Adherence apps, Telemedicine services and In-Home Diagnostic devices;
Improving quality, speed and cost-efficiency in Clinical trials with Risk Management solutions, Study Data Analysis tools and Study Compliance systems;
Improving speed and cost-efficiency in Clinical Practice of Healthcare Providers with AI-powered automated Diagnostic tools and voice-powered Physician’s Assistant tools.
You can download a free 20-page PDF version here. No registration required so far.


Igor Stefanov is CEO of Synergy Research Group, the World’s First Agile Risk-Based CRO, totally devoted to the Risk Based Thinking in Drug Development.