WMA-_South_African_MCC_-_Steel

Post Trial Access in Clinical Trials
Gavin Steel
Medicines Control Council
Clinical Trials Committee
Expert Conference on the Revision of the
Declaration of Helsinki
6th December 2012
The Westin Hotel, Cape Town, South Africa
Background
• Regulatory approval of Clinical Trials was
introduced in 2000
• Post Trial access
– Antiretroviral medicines
• Harm if treatment is withdrawn without alternatives.
– HIV prevention clinical trials
• National consultation in 2003
– Approach was expanded to all medicine in 2004
• Helsinki 2000 was used as point of reference
South African Regulatory approach
• Clinical Trial participants who are clearly
benefiting from the clinical trial intervention
should have post trial access until the medicine is
freely available in the public health system
• This must be clearly articulated in the informed
consent
• Date of registration in a resource constrained
environment is not appropriate:
– Affordability
South African Regulatory approach (2)
• The sponsor must, prior to approval, provide
unambiguous evidence of provision for post
trial access in the form of:
– An undertaking to provide the product at no cost
– A Memorandum of Understanding that the South
African government aggress to provide access at
not cost
South African Regulatory approach (3)
• Where the intervention is of considerable
public health interest, e.g. novel vaccines,
evidence of a reasonable approach to access
pricing is sought:
– Typically it takes the form of an undertaking for
phase I to II
– To date there has not been a test case for a phase
III but in principle it is believed that some sort of
agreement needs to be presented
South African Regulatory approach (4)
• Where the comparator is not standard of care
the control arm poses a specific problem:
– Sponsor can provide post trial access
• There is considerable resistance to the option
– A protocol for the stabilization on local standard of
care
• Memorandum of agreement for feeder clinics
South African Regulatory approach (4)
• The largest challenge is post trial access for
preventative health technologies without
proven safety and efficacy
– The position of the MCC is that harm may accrue
to the community where
• Safety profile has not been adequately characterised
• Therapeutic misconception may result in great risk
taking
– Recent case study has been the tenofovir gel
Amendments wrt post trial access
• Propose that the current provision be
amended to reflect:
– Identification of responsible agents
– That Post trial access be concluded prior to
approval
– No participant who
• is benefiting from the trial intervention
• does not have reasonable access to alternatives
should be denied access at no additional cost
Other considerations
• Bio banks
– Separate informed consent
– Exclusion is usually not allowed
• Vulnerable groups
– Over researched communities
• Publication
– Undertaking by the sponsor
• Ethics “shopping”
– Nationally and internationally
– Declaration with reasons for rejections
Thank you