Globalization of Clinical Trials  

Posted 15 January 2021

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Johan Karlberg

Abstract

The objective of this report is to display the current geographic distribution of industry-sponsored clinical trial sites.

The data represent industry-sponsored phase II/III clinical trials for a four year period, i.e. for trials registered with the US trial registry (clinicaltrials.gov) between January 1. 2017 to December 31, 2020.

The majority of the sites were located to North America and Europe – 39.7% and 21.8%, respectively or in total 61.5%. Asia and East Europe contributed together with 29.8% - 15.3% and 14.5%, respectively.

The top five countries with the largest number of study sites are Unites States (36.8%), Japan (5.2%), China (4.6%), Spain (4.1%) and Germany (4.0%). Together they represent 54.6% of all the sites and the leading 15 counties stands for 76.4% of the sites.

Site SOPs

Study Site Standard Operating Procedures (SOPs). Authors: Johan PE Karlberg and Selene Tam

Standard operating procedures (SOPs) are necessary to obtain and maintain high-quality conduct of human clinical research and to ensure compliance with regulatory standards. Clinical investigators must have access to well-written SOPs in order to guarantee that their sites mimic unfailing processes that meet regulatory and good clinical practice (GCP) standards and that all employees are familiar with those processes. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals (CH) GCP Guideline defines SOPs as “Detailed, written instructions to achieve uniformity of the performance of a specific function.

Study sites that have well-written, comprehensive and practical clinical research SOPs have a distinct advantage over those that do not. Well-written SOPs are the most efficient way to train new staff and to ensure that they continue working autonomously. They ensure consistency, compliance and accountability of personnel. Sites without clinical research specific SOPs run a high risk of non-compliance as well as poor productivity.

The 55 SOPs available here are applicable to any study site regardless of the location, jurisdiction, local language and specialty. They were developed by industry experts from Argentina, Australia, Brazil, Denmark, Germany, Hong Kong, India, Israel, Italy, Jordan, the Philippines, Russia, Singapore, South Africa and the United States.

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Basics of Clinical Trials

Reviewing Clinical Trials: A Guide for the Ethics Committee. Editors: Johan PE Karlberg and Marjorie A Speers

Although the publication is entitled Reviewing Clinical Trials: A Guide for the Ethics Committee, it was developed mindfully to be relevant and useful to all other categories of professionals entering the clinical trial research area.  We highly recommend anyone, whether a novice in the clinical trials research area or experienced, wishing to learn more about the basic modern concepts of human research ethics and clinical trial research methodology to study this manual. The audience can equally be professionals acting as investigators, research nurses, research support staff, ethics committee administrators, contract and budget development administrative staff, monitors, project managers, biostatisticians, clinical data managers, regulators or inspectors. 

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Trials. Sites and Subjects

Posted 24 February 2021

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By Johan Karlberg

Abstract

The objective of this report is to display the number of trials, study sites and subjects of industry-sponsored clinical trials.

The data represent industry-sponsored clinical trials for a four year period, i.e. for trials registered with the US trial registry (clinicaltrials.gov) between January 1. 2017 to December 31, 2020.

The number of trials are highly phase dependent – decreasing number of trials with increasing trial phase. The number of sites and subjects are also trial phase dependent.  Phase 3 trials have the highest number of sites per trial (52.9) and the highest number of subjects per trial (676.0), but the comparable number of subjects per site as phase 1 and 2 trials (13-16 per site).

The annual mean number of phase 2+3 trials is 1,830 counting for 63,000 sites and 860,000 subjects.

There is a large variation in the number of sites and subjects by therapeutic area and study phase (phase 2 and 3). One example is taken from the most popular therapeutic area – oncology; a phase 2 oncology trial has on average a sample size of 117.1 subjects and 5.2 subjects per site. In contrast a phase 3 oncology trial has a significant higher average sample size of 448.3 subjects and 6.7 subjects per site. 

Diseases / Conditions Industry-Sponsored Trials  

Posted 29 January 2021

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By Johan Karlberg

Abstract

The objective of this report is to display the type of diseases / conditions of global industry-sponsored clinical trials.

The data represent industry-sponsored phase II/III clinical trials for a four year period, i.e. for trials registered with the US trial registry (clinicaltrials.gov) between January 1. 2017 to December 31, 2020.

Oncology (23.5%) is the leading area followed by Infectious Diseases (14.1%), Neurology (8.0%) and Endocrinology (6.4%).

Lung Cancer, Covid-19 and Diabetes are the leading three diseases.