[e-drug] Globalisation of clinical trials and ethics of benefit sharing

e-drug
1

E-DRUG: Globalisation of clinical trials and ethics of benefit sharing
----------------------------------------------------------------------

Dear Colleagues,

As a first step to further investigate whether clinical trials testing high-cost, life-saving medicines in Middle Income Countries (MICs) result in universal access to the study findings in the trial countries, we preliminary explored the model of hematological malignancies. We choose this field because these tumors are curable in a substantial fraction of patients thanks to innovative drugs that, however, are generally not widely accessible in MICs because of pricing issues. We observed that 30% of phase 3, interventional, commercial trials submitted to ClinicalTrials.gov involved sites in MICs. The sizeable involvement of MICs in hematological clinical trials prompts an extra quest for ethical solutions to the problem of universal access to the medicines tested in these trials.

We preliminary suggest that medical journals should publish a complete list of trial sites, with details of number of cases/site; that regulatory agencies should require an "ethical clause" binding the marketing authorization holders to offer drugs at tiered prices in all MICs where trials are conducted; and that physicians and patients should lobby for a juxtum pretium for life-saving drugs tested in trials in their countries. We would be happy to hear if similar features have been observed in other therapeutic fields.

Our full comment may be freely read (upon registration) in the website of The Lancet Haematology, at http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(14)00004-0/fulltext?version=printerFriendly

Best regards,

Raffaella

Raffaella Ravinetto
Institute of Tropical Medicine
Antwerpen, Belgium
rravinetto@itg.be

2

E-DRUG: Globalisation of clinical trials and ethics of benefit sharing (2)
------------------------------------------------------------------------------------------

Dear Colleagues,
The other side of the coin to the concern that Raffaella rightly raises is
the number of drug trials carried out in developed countries (High Income)
and climate Zones I & II for new drugs or formulations that will be
predominantly used in the developing world, in resource poor settings and
climate zones III & IV. This is definitely a concern to those of us in the
HIV and AIDS field, do colleagues in other disease areas have similar concerns
or experience.

Regards
David Jamieson

Mr. David JAMIESON
Deputy Director, Project Planning and Global Partnerships
Supply Chain Management System (SCMS)
Partnership for Supply Chain Management (PFSCM)
1616 Fort Myer Drive, 12th Floor
Arlington, VA 22209 USA
Office phone: +1 571 227 8669
Cell: +1 202 316 4999
Email: djamieson@pfscm.org

3

E-DRUG: Globalisation of clinical trials and ethics of benefit sharing (3)
------------------------------------------------------------------------

Dear colleagues

I echo the concerns raised by David regarding stability testing of drugs.

With respect to HIV medicines, while WHO prequalification requires that all medicines undergoing prequalification be subjected to Zone IV stability studies and be labelled as such, with exceptions where the product is known not to be stable under such conditions, the USFDA tentative approval does not. What we end up with is the same product from the same manufacturer with Zone IV stability and labelling under WHO prequalification and with Zone II labelling under USFDA tentative approval and this complicates global procurement.

Typically, regulatory agencies in the source and recipient countries require that the product registered in their countries are subjected to stability studies that meet their country requirements. A global outlook has not been applied except with WHO prequalification.

Since the additional cost of performing Zone IV stability studies from Zones I, II and III is marginal, and the potential benefits immense, I recommend that ALL products be subjected to the maximum Zone IV stability studies and only exceptions be permitted. ICH guidance would be required.

It would also be of great help if formulation studies are carried out with Zone IV stability in mind so that the most stable formulation and dosage form is used.

Otherwise, resource limited settings will continue to invest in cold and cool chain processes to maintain products under Zone II or lower climatic conditions simply for lack of stability data to support Zone IV labelling and not because the product is unstable.

Atieno Ojoo
Technical Specialist, Pharmaceuticals, Supply Division, Copenhagen.
Phone: (45) 45 33 56 54
Email: aojoo@unicef.org

United Nations Children’s Fund
3 UN Plaza, New York, NY 10017
Follow us on Facebook, Twitter, YouTube and at www.unicef.org
Learn more about CRC@25 on unicef.org