Research

NOW is the time to TAKE ACTION: send your letter and make a difference - Download and sign the prewritten letter to the Minister of Health. Postage is not required.

Click here to read Hon. Judy Sgro's response to reading Lethal Dose (pdf, opens in new window)

Quick Links:
Auditor general slams Health Canada for failing to monitor drug safety
Public Clinical Trial Registries Updated March 26, 2009
Patient Care
Injury Compensation in Australia

UPDATE: In November of 2009, a Health Canada Senior Policy Analyst informed RwR that Canada would NOT be establishing a Public Registry of Clinical Trials although the Health Canada Website says that they are still studying the issue.


Public Clinical Trial Registry Issues

To protect patients and promote transparency and accountability, *Research with Respect* supports the WHO's International Clinical Trials Registry Platform, which calls for the public registering of all clinical trials.

Your Chance to Take Action for a Canadian Public Clinical Trial Registry

Canada currently does NOT have a Public Registry of Clinical Trials. We have asked Health Canada to establish a Public Registry of all Clinical Trials conducted in Canada.

MAKE YOUR VOICE HEARD ON THESE IMPORTANT POLICY ISSUES:

• Mandatory registration of ALL clinical trials conducted in Canada
• Registration of clinical trials on one specific country’s public registry just as a stop-gap measure until Canada establishes it own bi-lingual Public Registry of Clinical Trials:

YOU CAN MAKE A DIFFERENCE BY CONTACTING THE FEDERAL MINISTER OF HEALTH.

Download pre-written Clinical Trial Registry Petition Letter and mailing instructions.
NO POSTAGE REQUIRED on the envelope.

UPDATE:

For the Australia New Zealand Clinical Trials site it you can go to: www.anzctr.org.au the pertinent bits are in the articles noted in their brown bar on the left of the home page.

Changes have been made to the Declaration of Helsinki - which is the definitive standard for clinical trials and is included in the Protocol established between a Trial Sponsor and an Ethics Board when a new clinical trial is being established.  The Declaration of Helsinki, authored by the World Medical Association (WMA) in 1964, has had several reviews and amendments.  The latest is from the WMA's 59th Conference held in Seoul, October 2008.  The revised Declaration of Helsinki, #19, now states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject."
This is to be found at www.wma.net/e/policy/b3.htm

The International Editors of Medical Journals, who focused the world on the registration of clinical trials issue, can be found at www.icmje.org
For their latest directive that ALL trials, including Phase 1, must be registered on a Public Registry or they will not publish, go to Update on Trials Registration under ICMJE Editorials on the left side of their Home Page.


Click here to read the letter we wrote to Health Canada (PDF, 65 KB)
Click here to read the response to our letter from Dr. Sharma (PDF, 3.83 MB)

Health Canada's position on Public Clinical Trial Registries

The following is a reply to an inquiry by Research with Respect to Health Canada regarding the status of their response to the WHO request for the establishment of public clinical trial registries in every country:

Thank you for your correspondence of August 23 and 29, 2007 regarding the registration of clinical trials. Health Canada recognizes that improved public access to clinical trial information would be a means to further good research practices, assist consumers in making treatment decisions, and help increase public trust in clinical research.

As mentioned in our letter to you dated July 4, 2007, Health Canada is working to develop a regulatory requirement for the registration of clinical trial (CT) information. While this work progresses, we will be encouraging the registration of CTs Phases I-IV on www.ClinicalTrials.gov and will explore the possibility of creating a Canadian Clinical Trials Search Portal, which would allow bilingual searches of multiple WHO-compliant registries for clinical trials taking place in Canada.

In Fall 2007, Health Canada will issue a Notice to stakeholders in order to provide additional details on our initiative, including timelines. We will ensure that [Research with Respect] is included on the distribution list for this announcement in order to keep you informed of our next steps.

We would also like to take this opportunity to provide you with additional information that may help clarify some points that were raised in your letter.

First, as you mentioned, the International Committee of Medical Journal Editors (ICMJE), as well as editors of several specialized medical journals, made a call for public registration of clinical trials in September 2004.

The ICMJE announced that, beginning July 1, 2005, registration of clinical trials would be a prerequisite of consideration for publication; further clarification on how and where to register trials was provided in updates issued by ICMJE in October 2004 and May 2005.

On June 4th, 2007 the ICMJE issued an editorial to both clarify and update their policy on registration, and explained that they will accept registration in any primary register of the World Health Organization (WHO) International Clinical Trial Registry Platform (ICTRP).

Canadian clinical trial sponsors and researchers are able to meet this requirement by registering on either www.ClinicalTrials.gov or www.controlled-trials.com. Both of these registries accept trials taking place anywhere in the world and currently include hundreds of Canadian trials.

Next, regarding the WHO’s work on trial registration, you may wish to view their news release of May 19, 2006 which outlined their policy and called for the registration of "all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers." (See: www.who.int/mediacentre/news/releases/2006/pr25/en/index.html).

As stated in the news release, the WHO’s policy is voluntary. In addition, rather than directing individual countries to establish their own public clinical trials registries, the WHO Registry Platform has been working with stakeholders to agree on internationally appropriate norms and standards for trial registration and results reporting.

This includes the creation of a comprehensive network of registers and the development of the WHO International Search Portal for clinical trials, which was launched in May 2007 and allows users to search a central database that contains clinical trial information provided by collaborating registers.

For more information about the WHO Registry Platform, including the composition of the Register Network, please see the WHO ICTRP website at: http:/ /www.who.int/ictrp/en.

I hope that you will find this information helpful.
Sincerely,
Policy Analyst / Analyste des politiques
Therapeutic Products Directorate / Direction des produits thérapeutiques

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Patient Care Issues

End-of-life Care for Terminally Ill Participants in Clinical Research (PDF File, 117 Kb)
by MANISH AGRAWAL, M.D., and MARION DANIS, M.D.
Efforts to improve end-of-life care in the United States have paid little attention to the unique concerns of participants in clinical research who are terminally ill. In this paper we focus attention on and offer an analysis of how to meet the needs of these individuals.

Electronic Medical Records to Improve Patient Care (PDF File) “... the health care our patients receive will be better co-ordinated, better managed, and more efficient,” said Dr. Geoff Appleton, president of the BC Medical Association. “Patient records will be more accessible to health-care providers that need the information to deliver effective patient care, and they will be much more secure than is the current practice of storing thousands of paper files...”( Full PDF article )

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Australian and New Zealand Clinical Trial Registry (ANZCTR)

(For those of you interested in finding out about the Canadian stance on the establishment of a Clinical Trial Registry, the Director of Therapeutic Products at Health Canada directed us to www.canadapharma.org. However, they have not yet responded to our inquiry.)

In June 2005 the Australian and New Zealand Clinical Trials Registry was established at the NHMRC Clinical Trials Centre, University of Sydney, with funding from the Australian Government, through a National Health and Medical Research Council (NHMRC) Enabling Grant over 5 years.

The Registry has been designed to comply with the requirements of the International Committee of Medical Journal Editors (ICMJE), who have stated that member journals will not publish a clinical trial that commences enrollment after 1 July 2005 unless the trial has been registered on a public registry prior to patient enrollment in the trial.

The first version of the ANZCTR was developed within a very short time period to comply with the ICMJE policy, and will be further improved during the life of the Enabling Grant.

REFERENCES
[1] World Medical Association. World Medical Association Declaration of Helsinki (1964). April 1997.
Viewed on 06/01/2006, at: http://www.csu.edu.au/learning/ncgr/gpi/odyssey/privacy/HelDec.html

[2] The Nuremberg Code (1947). June 2002.
Viewed on 06/01/06, at:
http://www.cirp.org/library/ethics/nuremberg

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Injury Compensation in Australia

Article from Medicines Australia

The following article can be viewed in its original form on the Medicines Australia website by clicking here

GUIDELINES FOR COMPENSATION FOR INJURY RESULTING FROM PARTICIPATION IN A COMPANY SPONSORED CLINICAL TRIAL

Preamble

Medicines Australia favours a simple and expeditious procedure in relation to the provision of compensation for injury caused by participation in clinical trials.

Medicines Australia therefore recommends that a member company sponsoring a clinical trial (“the Sponsor”) should provide a written assurance to the investigator - and through him or her to the relevant Ethics Committee - that the following Guidelines will be adhered to, without legal commitment, in the event of injury caused to a Subject attributable to participation in the trial in question.

Non-members of Medicines Australia are encouraged to adhere to the principles outlined in these Guidelines.

These Guidelines are an adaptation of those used by the Association of the British Pharmaceutical Industry (ABPI), for use in Australia.

1. Basic Principles

1.1 Notwithstanding the absence of legal commitment, the Sponsor should pay compensation to participants in clinical trials (“Subjects”) suffering personal injury (including death) in accordance with these Guidelines.

1.2 Compensation should be paid when, on the balance of probabilities, the injury was attributable to the administration or use of a product under trial or any clinical intervention or procedure provided for by the protocol that would not have occurred but for the inclusion of the Subject in the trial.

1.3 Compensation should be paid to a child injured in utero through the participation of the child's mother in a clinical trial as if the child were a Subject with the full benefit of these Guidelines.

1.4 Compensation should only be paid for the more serious injury of an enduring and disabling character (including exacerbation of an existing condition) and not for temporary pain or discomfort or less serious or readily curable complaints.

1.5 Where there is an adverse reaction to a product under trial and injury is caused by a procedure adopted to deal with that adverse reaction, compensation should be paid for such injury as if it were caused directly by the product under trial.

1.6 Neither the fact that the adverse reaction causing the injury was foreseeable or predictable, nor the fact that the Subject has freely consented (whether in writing or otherwise) to participate in the trial should exclude a Subject from consideration for compensation under these Guidelines, although compensation may be reduced or excluded in the light of the factors described in paragraph 4.2 below.

1.7 For the avoidance of doubt, compensation should be paid regardless of whether the Subject is able to prove that the company has been negligent in relation to research or development of the product under trial or that the product is defective and therefore the Sponsor is subject to strict liability in respect of injuries caused by it.

2. Type of Clinical Research Covered

2.1 These Guidelines apply to injury caused to Subjects involved in clinical trials, that is to say, Subjects under treatment and surveillance and suffering from the ailment which the product under trial is intended to treat but for which a registration or listing approval does not exist or does not authorise supply for administration under the conditions of the trial (including Phase I, II and III clinical trials).

2.2 These Guidelines also apply to injuries arising from Phase I studies in either patient or non-patient volunteers, whether or not they are hospitalised.

2.3 These Guidelines do not apply to injury arising from clinical trials on marketed products where a registration or listing approval exists authorising supply for administration under the conditions of the trial, except to the extent that the injury is caused to a Subject as a direct result of procedures undertaken in accordance with the protocol (but not any product administered) to which the Subject would not have been exposed had treatment been other than in the course of the trial.

2.4 These Guidelines do not apply to clinical trials that have not been initiated or directly sponsored by or on behalf of the company providing the product for research.

2.5 Where trials of products are initiated independently by doctors under the appropriate Therapeutic Goods Act 1989 exemptions, responsibility for the health and welfare of Subjects rests with the doctor alone (see also paragraph 5.2 below).

3. Limitations

3.1 No compensation should be paid for the failure of a product to have its intended effect or to provide any other benefit to the Subject.

3.2 No compensation should be paid for injury caused by other registered or listed products administered to or used by the Subject for the purpose of comparison with the product under trial.

3.3 No compensation should be paid to Subjects receiving placebo in consideration of its failure to provide a therapeutic benefit.

3.4 No compensation should be paid (or it should be reduced as the case may be) to the extent that the injury has arisen through:

• a significant departure from the agreed protocol;

• the wrongful act or default of a third party, including a doctor's failure to deal adequately with an adverse reaction; or

contributory negligence by the Subject.

4. Assessment of Compensation

4.1 The amount of compensation paid should be appropriate to the nature, severity and persistence of the injury.

4.2 Compensation may be reduced, or in certain circumstances excluded, in the light of the following factors (on which will depend the level of risk the Subject can reasonably be expected to accept):

• the seriousness of the disease being treated, the degree of probability that adverse reactions will occur and any warnings given;

• the risks and benefits of established treatments relative to those known or suspected of the product under trial.

This reflects the fact that flexibility is required given the particular Subject’s circumstances. As an extreme example, there may be a Subject suffering from a serious or life-threatening disease who is warned of a certain defined risk of adverse reaction.

Participation in the trial is then based on an expectation that the benefit/risk ratio associated with participation may be better than that associated with alternative treatment. It is, therefore, reasonable that the Subject accepts the high risk and should not expect compensation for the occurrence of the adverse reaction of which he or she was told.

4.3 In any case where the Sponsor concedes that a payment should be made to a Subject but there exists a difference of opinion between the Sponsor and Subject as to the appropriate level of compensation, it is recommended that the Sponsor agrees to seek at its own cost (and make available to the Subject) the opinion of a mutually acceptable independent arbiter, and that this arbiter's opinion should be given substantial weight by the Sponsor in reaching its decision on the appropriate payment to be made.

5. Miscellaneous

5.1 Claims pursuant to the Guidelines should be made by the Subject to the Sponsor, preferably via the investigator, setting out details of the nature and background of the claim and, subject to the Subject providing on request an authority for the Sponsor to review any medical records relevant to the claim, the Sponsor should consider the claim expeditiously.

5.2 The undertaking given by the Sponsor extends to injury arising (at whatever time) from all administrations, clinical interventions or procedures occurring during the course of the trial but not to injury arising from administration or use of the product beyond the end of the trial. The use of unregistered or unlisted products beyond the trial period is wholly the responsibility of the treating doctor.

5.3 The fact that the Sponsor has agreed to abide by these Guidelines in respect of a trial does not affect the right of a Subject to pursue a legal remedy in respect of injury alleged to have been suffered as a result of participation. Any payment made to a Subject by the Sponsor will be made without admission of liability and Subjects may be asked to accept that any payment made to them is in full settlement of their claims.

5.4 The Sponsor should encourage the investigator to make clear to participating Subjects that the trial is being conducted subject to the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Clinical Trial and to have available copies of the Guidelines should they be requested.

 

 

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