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MEC and research
Transcript of MEC and research
Clinical trial support from the pharmacy
Sonja el Yandouzi, pharmD
Head of unit Clinical Trial Support
Pharmacy University Medical Center MEC and Research - All research with human subject's acts has to be performed according to the applicable Dutch Law and specifically WMO (Wet Mensgebonden onderzoek= Law research on human subjects)
Research is subject to the WMO if it meets the two following criteria:
- it is being carried out for medical/scientific research; and
- participants are subjected to procedures and/or are required to follow certain rules of behaviour.
-WMO is not only about trials with drugs. Research with
medicinal products There has to be an approval from the pharmacy involving the feasibility of a trial with drugs.
The feasibility is done by a pharmacist of the Unit Clinical Trial Support.
The feasibility is done by collaborating with the investigator or the CRA (Clinical Research Associate).
The MEC needs the signed approval (delegation log) from the pharmacy together with the study protocol, investigator's brochure and if applicable IMPD (Investigational Medicinal Product Dossier). When can we speak of
research with medicinal products? Paracetamol tablets (already registered) where we evaluate the side effects?
A medical device filled with salbutamol where we evaluate the use of this device?
Probiotics in patients with pancreatic cancer?
Vitamin K in a high dosage in volenteers to evaluate the side effects? The unit consists of 1 pharmacist and 4 pharmacy technicians who support, consult and coordinate 120 clinical trials at the moment.
The Unit can take care of the design, preparation, labelling, releasing, storage and dispense (drug accountability) of the used trial drugs. Unit Clinical Trial Support What is WMO and is all research covered by this law?
MEC's purpose is to protect the participants
To dispense trial drugs, the pharmacy needs
an approval from the MEC and a release document
from a QP (Qualified Person).
The committee consists of:
-Representative of the participants
-Clinical pharmacologist (only for trials with drugs) Why do investigators have to report to the MEC? Timetable MEC decision For ‘ordinary’ medical-scientific research, the MEC has a maximum of 8 weeks to come to a decision, unless the MREC had announced during this time period that it needs more time.
Specific time periods laid down in the WMO apply for research with medicinal products. The judgement by the MEC has to be within 60 days after receipt of the (primary) request. The MEC can submit a one-off request for further information and introduce a ‘clock stop’ within this 60 day time period.
http://www.ccmo-online.nl/hipe/uploads/downloads_catp/Standaarddossier_toelichting_engels_7-2012.pdf CCMO CCMO stands for Central Committee on Research Involving Human Subjects
Tasks of the CCMO:
-Accrediting MECs in several sites
-Reviewing protocols for medical research involving human subjects, trials with drugs have to be reviewed by CCMO and the MEC.
-Registering protocols for medical research involving human subjects such as gene therapy, vaccins, heroin addiction
-Administrative body dealing with appeals and objections
-Providing information about the implementation and application of the WMO
------> For more information: www.ccmo.nl The trial has been
reviewed by a MEC.
What now? The medical ethics review is over. If the
research committee has awarded a positive judgement, then you can, in principle, launch
However, the research committee remains in the picture, MECs often ask to be informed of the following aspects:
- Starting and finishing dates
- Protocol amendments
- SAEs/unexpected undesirable effects
- Premature termination
- Final results The Target trial: MEC “A randomized, placebo-controlled, double blind, 4-period, cross-over trial, to study the effects of Aliskiren, Hydrochlorothiazide (HCTZ) and Moxonidine on endothelial dysfunction in obesity related hypertension” n=36
This trial was done by the cardiovascular research team (UMC).
The Aliskiren is too big of a size to put in the same red capsules. A pharmaceutical manufacturer was willing to deliver the Aliskiren and placebo tablets.
The investigator was planning to only use Aliskiren and placebo tablets, he was not planning to use placebo for Moxonidine and HCTZ. The trial was first disapproved by the MEC. The investigator was obligated to use a double dummy design, to keep the trial double blind the trial. The Target trial: start up The pharmacy was only able to make capsules of only HCTZ and Moxonidine and placebo capsules. The reason was because of the
size of the tablets (right size to put a whole tablet into a red non-transparent capsule and fill with lactose, the placebo is filled only with lactose). The advantage of this method is to only analyze the placebo capsules. The QP release is done by the pharmacy.
The pharmacy had to randomize, dispense per schedule and per patient, label and dispense as stock. Also the deblinding procedure had to be done by the pharmacy (24/7).
The pharmacist had to audit the location of storage at the ward. The medicinal products were dispensed with a trial prescription.
The investigator had to keep his own drug accountability (per patient). After dispensing to a patient he had to write and sign a trial prescription per patient and send this document to the pharmacy.
All the activities were written and signed for in the pharmacy agreement. There was also a pharmacy budget. Target trial: start up 36 patients will be instructed to return any
unused study medication to the researcher
after completing the 24-hour blood pressure
Returned medication will be counted by the
Study medication will not be recycled, but
destroyed in accordance with the UMC Utrecht
pharmacy practice guidelines (GCP). The Target Trial: documents MEC -Study Protocol (with also a plan how to monitor)
-Pharmacy Agreement (delegation log)
-IMPD (Investigational Medicinal Product Dossier) with the following documents from the pharmacy: preparation protocol, set up of the randomization, label (protocol), certificate of analysis (placebo) and QP release documents.
-Risk Benefit Assessment The Target trial: randomizationThere were 36 patients planned for the trial, with a schedule period of 8 weeks (+2 weeks followup and wash out). Treatment period is 40 weeks:
Schedule A. 1 bottle with 125 tablets Aliskiren and
1 bottle with 125 capsules placebo for Moxonidine /HCTZ
Schedule B. 1 bottle with 125 capsules Moxonidine and
1 bottle with 125 tablets placebo for Aliskiren
Schedule C. 1 bottle with 125 capsules HCTZ and
1 bottle with 125 tablets placebo for Aliskiren
Schedule D. 1 bottle with 125 tablets placebo for Aliskiren and
1 bottle with 125 capsules placebo for Moxonodine/HCTZ
COMBI NUMBERS ARE RANOMIZED
at www.randomization.org The Target trial: randomization Target trial: Label
Which information is missing? For oral use
Medication no: ….
Period no: 1, 2, 3 or 4
P.I. : W. Spiering, PhD, MD
Keep out of reach of children
Apotheek UMC – Utrecht
Product no. 97987190 Batchno. Target trial:
drug accountability Drug accountability, containing
information such like:
-Date of stock mutation
-What kind of stock mutation: dispense,
-Name of the pharmacy employee
-Medication numbers and patient
-Actual stock -Close out by a monitor (independent person
who checks all the documents at the ward
-Deblinding the data by pharmacy
-Analysis of this data
-Report to the MEC with an end date
-An official letter from the MEC to all relevant
persons (also the pharmacist) whit an
end date of the trial
-Archiving study file for 20 years Target trial: End of study Thank you!