Ethics review and clinical trials

Abstract

Vigorous debate has taken place on the ethics of conducting clinical trials in the developing world.1Halsey NA Sommer A Henderson DA Black RE Ethics and international research. Research standards are the same throughout the world; medical care is not.BMJ. 1997; 315: 965-966Crossref PubMed Scopus (21) Google Scholar, 2Aaby P DeCock K Semba RD Cooper PA Vaughan W et al.Ethics of HIV trials.Lancet. 1997; 350: 1546-1547Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar, 3Mann JM Leadership is a global issue.Lancet. 1997; 350: 23Summary Full Text Full Text PDF PubMed Scopus (2) Google Scholar However, one fundamental issue has not been directly addressed: that the study population should benefit from the trial in which they have taken part.The HIV-1 trials clearly address the needs of developing countries, but most of their study populations will not benefit from the trials, simply because the cheaper zidovudine regimens are beyond their limited means and will probably remain so for some time to come. The clinical trials have become separated from the implementation of their findings, probably because the populations' actual health needs and resources were not taken into account during the trial design.We believe that trialists should take responsibility for not only testing an intervention's efficacy, but also for ensuring its local adoption once the trial is over. This approach requires collaboration between trialists, national ministries of health, and drug manufacturers. Indeed, many such collaborations already exist. The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases is co-developing drugs for tropical diseases with the pharmaceutical industry. This collaboration should make it possible for effective drugs to be approved rapidly and made available at concessionary prices for public-sector use in affected countries.4Olliaro P Will the fight against tropical diseases benefit from orphan drug status?.Trap Med Int Health. 1997; 2: 113-115Crossref PubMed Scopus (12) Google ScholarOn occasions, pharmaceutical companies have unilaterally donated large quantities of drugs to support worldwide WHO eradication campaigns. The first was Merck Sharp & Dohme's donation of ivermectin for onchocerciasis: a more recent example is SmithKline Beecham's offer of albendazole for WHO's Filariasis Control Programme.Agreements have also been set up between national drug regulatory authorities (DRA) and individual drug companies. In Sri Lanka, the manufacturer of the antibiotic, vancomycin, provides the drug at a reduced price to the local distributor in return for a guarantee that the drug will not be re-exported and sold at a profit in another country. This arrangement was set up because the local DRA was concerned that a drug considered essential in specific situations was basically unaffordable.A different form of collaboration has been developed between WHO, UNICEF, and vaccine manufacturers. In this arrangement, countries are able to buy the vaccines at prices that reflect their ability to pay. In return for charging poor countries lower prices, the manufacturers gain a large market which could not otherwise afford the vaccines.The developed world has much to gain from clinical trials in the developing world,5Mittra I Clinical cancer trials in developing countries.Lancet. 1997; 349: 290Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar but we must not forget that the primary responsibility of any trial is to directly benefit the population in which it is being conducted. Vigorous debate has taken place on the ethics of conducting clinical trials in the developing world.1Halsey NA Sommer A Henderson DA Black RE Ethics and international research. Research standards are the same throughout the world; medical care is not.BMJ. 1997; 315: 965-966Crossref PubMed Scopus (21) Google Scholar, 2Aaby P DeCock K Semba RD Cooper PA Vaughan W et al.Ethics of HIV trials.Lancet. 1997; 350: 1546-1547Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar, 3Mann JM Leadership is a global issue.Lancet. 1997; 350: 23Summary Full Text Full Text PDF PubMed Scopus (2) Google Scholar However, one fundamental issue has not been directly addressed: that the study population should benefit from the trial in which they have taken part. The HIV-1 trials clearly address the needs of developing countries, but most of their study populations will not benefit from the trials, simply because the cheaper zidovudine regimens are beyond their limited means and will probably remain so for some time to come. The clinical trials have become separated from the implementation of their findings, probably because the populations' actual health needs and resources were not taken into account during the trial design. We believe that trialists should take responsibility for not only testing an intervention's efficacy, but also for ensuring its local adoption once the trial is over. This approach requires collaboration between trialists, national ministries of health, and drug manufacturers. Indeed, many such collaborations already exist. The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases is co-developing drugs for tropical diseases with the pharmaceutical industry. This collaboration should make it possible for effective drugs to be approved rapidly and made available at concessionary prices for public-sector use in affected countries.4Olliaro P Will the fight against tropical diseases benefit from orphan drug status?.Trap Med Int Health. 1997; 2: 113-115Crossref PubMed Scopus (12) Google Scholar On occasions, pharmaceutical companies have unilaterally donated large quantities of drugs to support worldwide WHO eradication campaigns. The first was Merck Sharp & Dohme's donation of ivermectin for onchocerciasis: a more recent example is SmithKline Beecham's offer of albendazole for WHO's Filariasis Control Programme. Agreements have also been set up between national drug regulatory authorities (DRA) and individual drug companies. In Sri Lanka, the manufacturer of the antibiotic, vancomycin, provides the drug at a reduced price to the local distributor in return for a guarantee that the drug will not be re-exported and sold at a profit in another country. This arrangement was set up because the local DRA was concerned that a drug considered essential in specific situations was basically unaffordable. A different form of collaboration has been developed between WHO, UNICEF, and vaccine manufacturers. In this arrangement, countries are able to buy the vaccines at prices that reflect their ability to pay. In return for charging poor countries lower prices, the manufacturers gain a large market which could not otherwise afford the vaccines. The developed world has much to gain from clinical trials in the developing world,5Mittra I Clinical cancer trials in developing countries.Lancet. 1997; 349: 290Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar but we must not forget that the primary responsibility of any trial is to directly benefit the population in which it is being conducted.