❓ A WA parliamentary question seeks detailed information about drug trials involving Paliperidone and Risperidone at Fremantle Hospital's Alma Street Clinic, and the potential link to patient suicides. The response provides some information about a Paliperidone trial, ethical considerations, and funding, but declines to provide specific patient data due to privacy and definitional issues.
AnsweredQoN 8546Legislative Assembly
QuestionView source ↗
Concerning drug trials at Fremantle Hospital Adult Mental Health Service, known as Alma Street Clinic, I ask:
(a) has the Alma Street Clinic, its staff, or its patients participated in a trial or group of trials involving the drug Paliperidone or Risperidone in the last five years, and if so:
(i) has the trial been completed, or is it ongoing;
(ii) what was the purpose and scope of this trial;
(iii) how many patients participated in this trial, and how were these participants selected;
(iv) what results were found as a result of this trial;
(v) were there any negative side-effects or outcomes observed in this trial;
(vi) did anyone participating in this trial attempt or succeed in suicide during or after the trial;
(vii) what information were patients and families given about the drugs involved, and in what form was the information;
(viii) was consent given by patients or were families and/or carers of the patients consulted;
(ix) how much, if at all, were patients paid for their participation in this trial; and
(x) did either the staff or the hospital/clinic receive any payment related to this trial, and if so, how much and who from; and
(b) of all suicides of patients or out-patients of the clinic, how many of these individuals were being treated or had been recently treated with Paliperidone or Risperidone?
(a) has the Alma Street Clinic, its staff, or its patients participated in a trial or group of trials involving the drug Paliperidone or Risperidone in the last five years, and if so:
(i) has the trial been completed, or is it ongoing;
(ii) what was the purpose and scope of this trial;
(iii) how many patients participated in this trial, and how were these participants selected;
(iv) what results were found as a result of this trial;
(v) were there any negative side-effects or outcomes observed in this trial;
(vi) did anyone participating in this trial attempt or succeed in suicide during or after the trial;
(vii) what information were patients and families given about the drugs involved, and in what form was the information;
(viii) was consent given by patients or were families and/or carers of the patients consulted;
(ix) how much, if at all, were patients paid for their participation in this trial; and
(x) did either the staff or the hospital/clinic receive any payment related to this trial, and if so, how much and who from; and
(b) of all suicides of patients or out-patients of the clinic, how many of these individuals were being treated or had been recently treated with Paliperidone or Risperidone?
AnswerView source ↗
Answered
16 October 2012
Responded by
Minister representing the Minister for Mental Health
Response time
35 days
a) There has been one trial involving Paliperidone in the last five years and none with Risperidone.
i) The trial involving Paliperidone is ongoing.
ii) Most trials have a number of separate hypotheses which are being evaluated. In general researchers are attempting to define the best use of these medications and to improve upon our existing knowledge base. The Paliperidone trial is looking at the clinical outcomes of using Paliperidone.
iii) In general, numbers of patients recruited are often fairly small - some trials may only recruit a few patients as part of large multi-centre collaborative trials involving multiple institutions in Australiaand overseas. Patients are selected for possible inclusion according to the principles laid down by the National Health and Medical Research Council (NHMRC) in the National Statement. There are inclusion and exclusion criteria which must be met, and then informed patient consent is obtained. All trials are approved by the South Metropolitan Human Research Ethics Committee, an independent committee which operates under the guidelines of the NHMRC National Statement.
iv) Results of trials on Risperidone and Paliperidone are complex scientific reports which are publicly available documents. These reports include documentation of adverse events including suicide or attempts at suicide. Information about individual patient outcomes is not reported and is subject to confidentiality.
v) As above.
vi) As above.
vii) Patients and families involved in clinical trials are provided with written patient information sheets which describe the nature and purpose of the trial, their rights and the implications of participating in the trial; and the possible benefits and risks of participation.
viii) Consent is obtained from the patient if they are competent to do so. If the patient is not competent to give consent, then the researcher may apply to the South Metropolitan Human Research Ethics Committee for consent to be obtained from the next-of-kin. If the Committee considers that the trial fits within the guidelines from the NHMRC describing conditions under which next-of-kin consent is reasonable, then it will grant approval for next-of-kin consent.
ix) Patients are never paid for participating in trials, as this would conflict with the principles in the NHMRC National Statement. Occasionally, reasonable expenses may be recouped such as travel costs to attend a follow-up session or parking fees.
x) If the trial is initiated from an external agency, such as a pharmaceutical company, then the hospital may receive payment for research staff time. The researchers themselves do not receive any payment. If the trial is initiated by researchers themselves, then the trial is either unfunded or receives funding from competitive peer?reviewed grants from bodies such as the NHMRC or other research?funding entities. Either way, the researcher does not get paid directly and payments are made to the Hospital which administers the funding.
b) This information is not available. To answer this question would require a review of individual patient records of all suicides over the last five years, and an understanding of what the Member means by "recently treated with Paliperidone or Risperidone".
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i) The trial involving Paliperidone is ongoing.
ii) Most trials have a number of separate hypotheses which are being evaluated. In general researchers are attempting to define the best use of these medications and to improve upon our existing knowledge base. The Paliperidone trial is looking at the clinical outcomes of using Paliperidone.
iii) In general, numbers of patients recruited are often fairly small - some trials may only recruit a few patients as part of large multi-centre collaborative trials involving multiple institutions in Australiaand overseas. Patients are selected for possible inclusion according to the principles laid down by the National Health and Medical Research Council (NHMRC) in the National Statement. There are inclusion and exclusion criteria which must be met, and then informed patient consent is obtained. All trials are approved by the South Metropolitan Human Research Ethics Committee, an independent committee which operates under the guidelines of the NHMRC National Statement.
iv) Results of trials on Risperidone and Paliperidone are complex scientific reports which are publicly available documents. These reports include documentation of adverse events including suicide or attempts at suicide. Information about individual patient outcomes is not reported and is subject to confidentiality.
v) As above.
vi) As above.
vii) Patients and families involved in clinical trials are provided with written patient information sheets which describe the nature and purpose of the trial, their rights and the implications of participating in the trial; and the possible benefits and risks of participation.
viii) Consent is obtained from the patient if they are competent to do so. If the patient is not competent to give consent, then the researcher may apply to the South Metropolitan Human Research Ethics Committee for consent to be obtained from the next-of-kin. If the Committee considers that the trial fits within the guidelines from the NHMRC describing conditions under which next-of-kin consent is reasonable, then it will grant approval for next-of-kin consent.
ix) Patients are never paid for participating in trials, as this would conflict with the principles in the NHMRC National Statement. Occasionally, reasonable expenses may be recouped such as travel costs to attend a follow-up session or parking fees.
x) If the trial is initiated from an external agency, such as a pharmaceutical company, then the hospital may receive payment for research staff time. The researchers themselves do not receive any payment. If the trial is initiated by researchers themselves, then the trial is either unfunded or receives funding from competitive peer?reviewed grants from bodies such as the NHMRC or other research?funding entities. Either way, the researcher does not get paid directly and payments are made to the Hospital which administers the funding.
b) This information is not available. To answer this question would require a review of individual patient records of all suicides over the last five years, and an understanding of what the Member means by "recently treated with Paliperidone or Risperidone".
Notice: This document is created or edited using unregistered or evaluation copy of rtLib valid for testing or development purposes only. To use it for productive or any other purposes please register it. You may purchase the license on
http://www.rtlib.com
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