Trial Supplies a pharmacy angle

1
Trial Suppliesa pharmacy angle

• VIain Fenton-May
• Specialist Pharmacist QC Wales
• St Marys Pharmaceutical Unit
• Cardiff

2
Types of Clinical Trials in Hospitals

• Hospital initiated
• and controlled
• Company initiated
• and controlled
• Company initiated
• hospital controlled

• Existing products
• New form of existing entity
• New entity

3
Activities associated with supply of Clinical
trials

• Preparation/ Manufacture
• Blinding
• Organising
• Labelling
• Dispensing

www.ct-toolkit.ac.uk
4
Roles (in Pharmacy)

• Adviser to Ethics Committee
  (Clinical Pharmacist)
• Organiser and keeper (CT co-ordinator)
• Manufacturer (Production Pharmacist)
• QP (Quality Control Pharmacist)

5
Licence requirements

• Clinical Trials Authorisation ( from MRAH)
• MA (IMP)
• Hospital Pharmacy (Section 37 exemption)

N.B. this applies to prepacking in Hospitals
and Health Centres the Directive describes
Hospitals and Clinics
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Hospital Initiated TrialExisting Product (MA)

• Licence
• Hospital Pharmacy (sec 37 exemption)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist

Assumption small scale
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Hospital Initiated TrialNew form of Existing
Product

• CTA
• Licence
• ML (IMP)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist
• Manufacturing Pharmacist
• QP (IMP)

8
Hospital Initiated TrialNew entity

• ?

Colpamine, Asacol, Nicotine enema
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Company Initiated TrialHospital ControlExisting
Product (MA)

• CTA
• Licence
• Hospital Pharmacy (sec 37 exemption)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist

Assumption small scale
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Company Initiated TrialHospital ControlNew Form
of Existing Product

• CTA
• Licence
• ML (IMP)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist
• Hospital QP (IMP)

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Company Initiated TrialHospital ControlNew
Entity

• ?

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Company Initiated TrialCompany ControlExisting
Product (MA)

• CTA
• Licence
• Hospital Pharmacy (sec 37 exemption)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist
• Company QP (IMP)

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Company Initiated TrialCompany ControlNew Form
of Existing Product

• CTA
• Licence
• Company ML (IMP)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist
• Company QP (IMP)

14
Company Initiated TrialCompany ControlNew Entity

• CTA
• Licence
• Company ML (IMP)
• Responsibilities
• Advisor to Ethics committee
• Clinical Trials Pharmacist
• Company QP (IMP)

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Required readingwww.ct-toolkit.ac.uk

• Good Practice in relation to supplies for
  publicly funded trials
• Labelling of IMPs
• GMP annex 13 (Manufacture of IMPs)
• Good Practice in Hospitals
• MHRA application for Manufacturers Authorisation

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Active Substance
Already recognised in Practice
New
No
Yes
New Entity
Is there an appropriate Marketed form
No
Yes
Licenced indications In line with trial usage
No
Hospital Preparation
Yes
Dispensing label requirements
Placebo required
No
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New Product
Specification and formulation details required
for CTA (inc. Placebo)
! Contact Pharmacy !
Find a licenced manufacturer (needs an
appropriate IMP MA)
Manufacturing details for CTA
Agree standards and Description of product
GMP
Annex 13
Labelling
QP release
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New Entity (Unlicenced product)
From within the EEA
No
IMP MA
Importation licence required
QP assessment And release
QP release
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Standard Operating Procedure

• Requests for Clinical Trial materials can only be
  considered if a Clinical Trials Authorisation
  certificate has been issued by the MHRA. A copy
  of which will be held in the trial file in the
  Unit.
• The Unit must be in possession of the Trial
  protocol.
• No Trial material will leave the Unit unless
  written approval has been given by the Qualified
  Person

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A pharmacy product specification file

• A copy of the CTA
• The name of the Sponsor
• The name of the Principal Investigator
• The name of the Qualified Person
• A copy of the Trial Protocol
• Code break policy
• Main contact, nominated by the Sponsor

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•          The product specification
• (To include, where appropriate)
• Stability information
• Randomisation policy
• Analytical information
• Source
• Standards
• Release criteria
• Containers
• Label design

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Standard Operating Procedure (costing)

• Based on a DRAFT Protocol an ESTIMATE can be
  produced for the Investigators information as a
  guide to the viability of the Trial.
• Actual quotes can only be given on the receipt
  the FINAL Protocol
• Any changes to the trial can only proceed
  following a further estimate of any new costs and
  the relevant request to the MHRA for a variation
  to the CTA.

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N.B.

• The arrangements for your trial supplies should
  be made early in the trial planning process. The
  protocol must include details of these
  arrangements. If you are using a hospital
  pharmacy, you should discuss your options with
  them.
• Supplies are dependent on
• manufacture, assembly, labelling, and dispensing