Title: Trial Supplies a pharmacy angle
1Trial Suppliesa pharmacy angle
- VIain Fenton-May
- Specialist Pharmacist QC Wales
- St Marys Pharmaceutical Unit
- Cardiff
2Types 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
3Activities associated with supply of Clinical
trials
- Preparation/ Manufacture
- Blinding
- Organising
- Labelling
- Dispensing
www.ct-toolkit.ac.uk
4Roles (in Pharmacy)
- Adviser to Ethics Committee
(Clinical Pharmacist) - Organiser and keeper (CT co-ordinator)
- Manufacturer (Production Pharmacist)
- QP (Quality Control Pharmacist)
5Licence 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
6Hospital Initiated TrialExisting Product (MA)
- Licence
- Hospital Pharmacy (sec 37 exemption)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
Assumption small scale
7Hospital Initiated TrialNew form of Existing
Product
- CTA
- Licence
- ML (IMP)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
- Manufacturing Pharmacist
- QP (IMP)
8Hospital Initiated TrialNew entity
Colpamine, Asacol, Nicotine enema
9Company Initiated TrialHospital ControlExisting
Product (MA)
- CTA
- Licence
- Hospital Pharmacy (sec 37 exemption)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
Assumption small scale
10Company Initiated TrialHospital ControlNew Form
of Existing Product
- CTA
- Licence
- ML (IMP)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
- Hospital QP (IMP)
11Company Initiated TrialHospital ControlNew
Entity
12Company Initiated TrialCompany ControlExisting
Product (MA)
- CTA
- Licence
- Hospital Pharmacy (sec 37 exemption)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
- Company QP (IMP)
13Company Initiated TrialCompany ControlNew Form
of Existing Product
- CTA
- Licence
- Company ML (IMP)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
- Company QP (IMP)
14Company Initiated TrialCompany ControlNew Entity
- CTA
- Licence
- Company ML (IMP)
- Responsibilities
- Advisor to Ethics committee
- Clinical Trials Pharmacist
- Company QP (IMP)
15Required 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
16Active 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
17New 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
18New Entity (Unlicenced product)
From within the EEA
No
IMP MA
Importation licence required
QP assessment And release
QP release
19Standard 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
20A 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
21- The product specification
- (To include, where appropriate)
- Stability information
- Randomisation policy
- Analytical information
- Source
- Standards
- Release criteria
- Containers
- Label design
22Standard 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.
23N.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