Covid-19 Trial Effect

Posted 11 March 2021

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By Johan Karlberg

Abstract

The objective of this report is to display the number of trials and study sites of industry-sponsored clinical trials in relation to the year prior to the Covid-19 Pandemic (year 2019) and during the first year of the Covid-19 Pandemic (year 2020).

  • There was an increase (18.7%) in the total number of trials between the two year of observation, i.e. an increase during the Pandemic year; phase I and phase II trials showed the largest increase.
  • There was a decrease (22.0%) in the total number of global study sites between the two year of observation, i.e. a decrease during the Pandemic year; phase III and phase IV trials showed the largest decrease.
  • US versus Non-US sites show about the same decrease in the number of sites over the two year of observation especially for phase II/III trials.

Conclusion: We can note an increased activity by means of the number of industry sponsored trials during the first Covid-19 Pandemic year. The number of study sites have however showed the reverse development, i.e. a decrease. The industry is predictably preparing for a strong increased site activity once the Pandemic situation has improved.

Terminated Trials

Posted 26 February 2021

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By Johan Karlberg

Abstract

The objective of this report is to display the number and type of terminated 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.

Overall 1,243 studies were Terminated representing 6.38% of the total number of studies (Table 1). Phase II trials have a relatively larger number of Terminated studies (8.75%).

There is a variation in the proportion of trials Terminated in respect to therapeutic area; Psychiatrics has the highest number of Terminated trials (12.9%) as compared with the lowest (2.8% ) for Ophthalmology.  Other areas with high termination rate are Pulmonary, Allergy, Gastroenterology and Neurology.

Table 2 also provides information about the thousands of study sites that were hurt by trial Termination. The number of sites terminated are highly therapeutic area dependent.

The termination rate varies between  0% to 23.3% among the top 66 diseases.

US Study Sites - Geographic Distribution  

Posted 22 January 2021

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By Johan Karlberg

Abstract

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

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.

During the study period of four years there were 93,0911 industry-sponsored phase II/III trial sites in the US. California, Florida and Texas were the leading states together representing 33.4% of all sites. The top ten states contributed with over half (58.4%) of the number of US sites.

Florida with the second highest number of sites – after California – has also a relatively high number of sites in relation to the underlying population. The population density ranges between 14 and 622 sites per million population with an average of 256.8.

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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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. 

Oncology Clinical Trials  

Posted 5 February 2021

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By Johan Karlberg

Abstract

The objective of this report is to display the number and type of industry-sponsored oncology 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.

About one in four trials is conducted in lung cancer or breasts cancer both globally and in the US.

The top 10 cancer types globally represent together 67.9% and 69.1% of all trials and subjects respectively. The top five cancer type in the US are the same as those identified globally.

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.

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.