Investigational Medicinal Products Comparator Subgroup

1
Investigational Medicinal ProductsComparator
Subgroup

• Status Update December 2002

2
IMPG Comparator Subgroup

• Subgroup (Working) Group was created early 2000
• Objective was
• create a forum for knowledge exchange
• to prepare a presentation on comparator
  development for the ISPE - IMPG 2000 Seminar

3
IMPG Comparator Subgroup

• Mission Statement
• To establish a forum for exchange of
  experience related to selection, exchange of
  comparators and /or documentation, manufacture
  and blinding techniques as well as regulatory and
  safety aspects laid down in all industry
  guidelines

4
IMPG Comparator SubgroupRules of Participation

• Members have a good knowledge of manufacture and
  blinding of comparators.
• Free to communicate openly and discuss in-house
  information.
• Monthly or bimonthly telefonconference
• Information kept confidential within subgroup and
  only further communicated in a neutral form by
  common consent.

5
IMPG Comparators SubgroupMembers of group

• Astra Zeneca (UK)
• Aventis (F)
• Glaxo Wellcome (UK)
• Novartis (CH)
• NovoNordisk (DK)
• Pfizer (UK)
• Sanofi (F)

6
Before ISPE Seminar 2000

• Surveys with the following topics have been
  created and filled in by each participating
  company
• Planning
• Procurement
• Characterisation / Stability issues
• Bio-equivalence issues
• Blinding / Deblinding
• Placebos
• The results of the surveys have been compiled and
  presented at the ISPE Seminar.

7
IMPG Comparators SubgroupTopics Covered

• Planning
• Procurement
• Characterisation/ Stability issues
• Blinding/ deblinding
• Placebos / Placebos matching to marketed products
• Providing Products to each other
• Analytical testing / stability testing
• Regulatory aspects
• Study Designs

8
Proposed Next Steps after ISPE Seminar 2000

• Complete Bioequivalence questionnaire.
• Investigate issues around carrying out more open
  studies (would this lead to increase in subject
  numbers?)
• Encourage participation of other companies.
• Encourage ways that companies can co-operate over
  comparator studies.
• Develop a comparator guideline.
• Provide industrial viewpoint for EU CT Directive.

9
After the ISPE Seminar 2000

• At first the participants have organized every
  two to three months teleconferences to exchange
  their experience with comparators and
  requirements of the authorities (incl. Annex 13).
• Then the idea came up to create a Guide on
  development of comparators with face to face
  meetings twice a year.
• Unfortunately the workload became too demanding
  and most of the participants had to leave the
  group.

10
Benefit

• The members of this working group very much
  appreciated the broad overview they have gained
  during their participation. It enables them to
  make better decisions in their daily business
  related to all comparator aspects in clinical
  trials.

11
Proposal for the future

• Come back to the first mission
• Establish a forum for exchange of experience
  related to selection, exchange of comparators and
  or documentation, manufacture and blinding
  techniques as well as regulatory and safety
  aspects laid down in all industry guidelines.
• Have four teleconferences a year.
• Encourage other companies to join the remaining
  core group