CTM's Subscriber Surveys

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Archive: CTM Subscriber Surveys

This page includes all subscriber surveys produced by Clinical Trial Magnifier since January 2008. 

Magnifier Subscriber Survey – The Ethics Guide.


Author: Johan PE Karlberg. Published in June 2010.

Objective: Our publication Reviewing Clinical Trials: A Guide for the Ethics Committee, released and publicized in April 2010, had been downloaded 8,500 times from our website Reviewing Clinical Trials: A Guide for the Ethics Committee by the end of June 2010.  In early May 2010, Clinical Trial Magnifier subscribers downloading the ethics committee guide were invited to respond to a survey gauging their opinions on it.

Response Rate:  A total of 686 responded, with 339 of them saying they had read most of it. The following findings are based on survey responses from those 339 respondents.

Conclusion:  (1) The newly-published Reviewing Clinical Trials: A Guide for the Ethics Committee has satisfactorily covered most aspects of clinical trials – from ethics and science to quality control. (2) The guide is especially useful for most clinical trial professionals – study staff, EC/IRB members and industry staff – with less than five years of working experience. (3) It also provides the minimum level of course information.
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Download Survey (1727 downloads)

Magnifier Subscriber Survey – Study Site Location Selection Criteria.


Author: Johan PE Karlberg. Published in September 2009.

Objective: Selection of study site is an amalgam of many factors.  This study examined the importance and rating of such factors. In September 2009, Clinical Trial Magnifier subscribers were invited to participate in a short online survey addressing these questions:

  1. Do any selection criteria stand out as more important than the others?
  2. Do views differ between industry and non-industry players?
  3. Do these views vary among regions/countries of residence?

Response Rate: There were 260 respondents to the survey; 75 (28.8%) worked in for-profit organisations (“industry”) and the majority, 185 (71.2%), worked in academia, governmental bodies or other non-for-profit organisations.

Conclusion: (1) Speed and quality are the most important site selection criteria while study site cost is not. (2) Speed is measured by different terms – size of available patient population, regulatory and ethics committee approval time, and time to site initiation. (3) Quality is also measured differently – whether track records, GCP knowledge or infrastructure development. Site cost is not a key element in the site selection process. (4) Neither is patent protection nor potential market size. (5) Financial aspects are thus very much secondary considerations when it comes to site selection.

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Download Survey (4673 downloads)

Magnifier Online Subscriber Survey – Central Issues of Investigator Initiated Clinical Studies.


Author: Johan PE Karlberg. Published in May 2009.

Objectives: This survey sought the views of Magnifier subscribers on ii-trials and industry sponsored trials in respect of research ethics, data quality, indemnity, insurance and contractual matters.

Response Rate: There were 273 subscriber responses.

Conclusions: This survey indicated general opinion that investigator-initiated clinical studies should comply with the same standards as industry sponsored clinical trials, as about half of the respondents did not believe this to be the case in real life. For now, there are clearly two different sets of standards – a topic we intend to further scrutinize. There are also major differences between “sides” in perception of ii-study contracts, leaving the contract development process vulnerable to misunderstanding, frustration, anger and long delays. A consensus in this area, at least, would seem beneficial for both parties.

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Download Survey (1220 downloads)

Magnifier Subscriber Survey – Phase I Trial Safety Concerns.


Author: Johan PE Karlberg. Published in March 2009.

Background: In March, 2006, six volunteers at Northwick Park Hospital in London, UK were given small doses of TGN1412, a new drug that was first being tested in humans. The trials were conducted in a private Phase I Unit owned by for-profit US based contract research organization, Parexel International Limited. All six subjects became seriously ill and had to be moved to an Intensive Care Unit at the hospital.

Objective: This Clinical Trial Magnifier survey sought to establish subscriber views on Phase I trials – more specifically about risks, guidelines, education and trial subjects. A few questions also relate to Microdosing trials – so called Phase 0 trial. The study was conducted among Clinical Trial Magnifier subscribers in March 2009.

Response Rate: The survey was returned by 378 subscribers.

Questions: There were several questions addressing the risk of early phase clinical trials:

  1. Has the incident at Northwick Park Hospital in London increased your safety concerns in early Clinical Trials?
  2. Do you face increased Clinical Trial Recruitment problems after the incident at Northwick Park Hospital in London?
  3. Do you think there is a need to change the design or structure of Pre-clinical Studies?
  4. Do you think the Clinical Trial Guideline should be tightened after the incident Northwick Park Hospital in London?
  5. Do you think that there is a need for developing an International Clinical Trial Guideline for Phase I trials?
  6. Do you think that there should be a mandatory education for those conducting Phase I trials?
  7. Do you think that patients included in Phase I trials should be paid in the same manner as healthy volunteers?
  8. Do you see more and more interest by the industry to conduct Phase I trials in patients?
  9. Do you believe that Phase I trials in patients should be conducted in a dedicated Phase I unit and not in a normal hospital ward?
  10. What is your view on the usefulness of Microdosing studies compared with the current animal model for predicting pharmacokinetics and pharmacodynamics of a study drug?
  11. Will Microdosing studies reduce the overall cost of drug development process?
  12. Do you think Microdosing Studies should become a routine first-in-human studies?

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Download Survey (6292 downloads)

Web-based Magnifier Survey – Indirect Fee and IRB Fee among US Clinical Institutions.


Author: Johan PE Karlberg. Published in February 2009.

Objective: In this web-based survey we aimed to identify the institutional overhead/indirect fee and the IRB fee for industry sponsored clinical trials for the leading 60 medical schools in the US, as rated by the US National Institute of Health. The primary aim was to find out if the top US universities had a different fee structure than other US medical institutions.

Response Rate: We identified the indirect fee for 44 (73.3%) and the IRB fee for 40 (66.6%) of all the 60 leading US medical schools.

Results: The average institutional indirect fee among US medical schools or institutions is about 26%, whether the institution is rated among the top 60 in the US, or not. The mean IRB fee among US medical schools or institutions is US$2,000 whether the institution is rated among the top 60 in the US, or not.
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Download Survey (4135 downloads)

Magnifier Subscriber Survey - Institutional Indirect Fees and Administrative Fees for Industry Sponsored Clinical Trials.


Author: Johan PE Karlberg. Published in February 2009.

Objective: The objective was to collect information from institutional investigative sites about their indirect and administrative fees. Respondents from the same institution were counted once only. The study was conducted among Clinical Trial Magnifier subscribers in February 2009.

Response Rate: There were 99 replies. Two respondents provided unrealistic replies, eight left all fields empty and two institutions had multiple respondents. This left us with valid information from 85 institutions or health care organizations; 48 located in the US and 37 from the rest of-the-world.

Questions: There were several questions addressing the fee structure of industry-sponsored clinical trials:

  1. Institutional indirect fee
  2. Institutional start-up fee
  3. Institutional administrative fee
  4. Feasibility assessment fee
  5. Various IRB fees

Clinical-Trial-Magnifier-Download
Download Survey (3246 downloads)

Magnifier Subscriber Survey - Incentives for Participation in Industry Sponsored Clinical Trials.


Author: Johan PE Karlberg. Published in January 2009.

Objective: This study aims to map out the major incentives for investigators to participate in sponsored clinical trials. The study was conducted among Clinical Trial Magnifier subscribers in January 2009.

Response Rate: There were 465 replies. The respondents were from 70 countries: 158 (34.0%) from the US, 98 (21.1%) from Europe excluding former East Europe, and the remaining 209 (44.9%) from other geographic regions.

Questions: There were five categories of questions, each with several sub-questions:

    1. What is your view on the incentives for an INVESTIGATOR TO PARTICIPATE in a sponsored clinical trial?
    2. What is your view on the reasons for an INVESTIGATOR TO REJECT PARTICIPATION in a sponsored clinical trial?
    3. What is your view on the factors adversely affecting an INVESTIGATOR’S PERFORMANCE in a sponsored clinical trial?
    4. What is your view on the incentives for a STUDY SUBJECT TO PARTICIPATE in a sponsored clinical trial?
    5. What is your view on the reasons for a STUDY SUBJECT NOT TO PARTICIPATE in a sponsored clinical trial?

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Download Survey (7143 downloads)

Magnifier Subscriber Survey - Clinical Research Guidelines.


Author: Johan PE Karlberg. Published in December 2008.

Objective: The aim of this study was to review the significance of the Declaration of Helsinki. Has it lost its influence? Is the ICH GCP Guideline, for instance, a more proper human research ethics document? The study was conducted among Clinical Trial Magnifier subscribers in November and December 2008.

Response Rate: There were 324 responses over three weeks. The majority (84.3%) were primarily working in clinical areas, with 227 (70.1%) working in academic or medical institutions and another 61 in the life-science industry or contract research organizations.

Questions: There were five categories of questions, each with several sub-questions:

  1. Have you ever read any version of the Declaration of Helsinki?
  2. Have you ever read any version of the ICH GCP Guideline?
  3. Which of the following document(s) is/are the current recognized human research ethics document(s) in your organization?
  4. Which version of the Declaration of Helsinki is adopted in your organization?
  5. Which of the following sentences is most agreeable to you? (1.) The Declaration of Helsinki is still the key human research ethics document. (2.) The Declaration of Helsinki has lost its importance as the key human research ethics document. (3.) The ICH GCP Guideline or your local GCP Guideline has become the key human research ethics document. (4.) No opinion.

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Download Survey (5701 downloads)

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Mark Twain

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