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.

About Clinical Budgets 

Posted 23 November 2020

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Johan Karlberg

Abstract

This survey was conducted in September and October 2020. US clinical trial sites were invited by email to participate in a web based survey. Seventy sites responded on the invitation. The average number of industry-sponsored trials conducted by the sites during the past three years was 30.5 trials. 

Standardized/Harmonized Clauses For Clinical Trial Agreements

Posted 23 November 2020

A Collaboration between the National Cancer Institute and the CEO Roundtable on Cancer

Clinical Trial Agreements are presented in two groups:
Part I: Clauses for company-sponsored Clinical Trial Agreements
Part II: Clauses for investigator–initiated Clinical Trial Agreements

 

Useful Publications - Free Download

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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About Conducting Clinical Trials 

Posted 23 November 2020

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

Amy Corneli, Christine Pierre, Terri Hinkley, Christopher B. Fordyce, Gerrit Hamre, Matthew T Roe

Abstract

Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA) Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs) decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1) workload balance (balancing trial implementation with other work obligations and opportunities) (63.8%); 2) time requirements (time to initiate and implement trial; investigator and staff time) (63.4%); and 3) data and safety reporting (56.5%). Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.