|The HIV Netherlands Australia Thailand Research Collaboration (UNAIDS, 2001, 51 p.)|
In its three years of operation, HIV-NAT has learned that:
1) Clinical trials can be conducted according to Good Clinical Practice guidelines in Thailand and should be feasible in other settings outside of the western world.
2) With support from existing overseas clinical HIV research organizations and the local MOPH, an HIV clinical research organization was able to be set up in Thailand within three years. The organization is financially nearly self supporting through its study generated income and grants, and needs to rely less and less on financial and intellectual support from the founding organizations.
3) One needs to dare make a start. The income generated by the first two studies barely paid for the expenses, but study generated income has gradually increased over time. For two studies that are about to start, HIV-NAT will receive financial compensation equal to the amount received by participating sites in the same projects in Europe, Australia and the US. This increase in income has allowed the organization to grow in terms of staff and other resources, such as additional education for staff and improved office facilities which in turn improve the overall quality of study conduct.
4) For the first three protocols, HIV-NAT was unable to guarantee follow-up medication to participants upon initiation of the studies. Now, all interested participants have been able to enrol in follow-up protocols, after the sponsors confidence in our work grew and enthusiasm for our activities increased. For three later studies, HIV-NAT has been able to obtain longer-term drug availability guarantees, either directly from the sponsors or through a reduced pricing scheme.
5) Clinical trials do create access to effective drugs, but only for a limited number of people considering the efforts and resources invested. Gaining access to treatment for patients may therefore not be the correct primary reason for participating in clinical research.
6) Clinical trials are labour intensive anywhere, but even more so in a setting where not all those involved are thoroughly familiar with clinical research. The coordinating center needs to have enough manpower and time available. The following aspects stand out from the HIVNAT experience:
a) Adequate personnel willing to learn new skills need to be available at any research site to make the research succeed. HIV-NAT has learned that without dedicated staff and a responsible study coordinator present at every individual research site, the effort is often doomed. For many staff members at satellite sites, conducting the study is only one of many duties and clinical studies are, by definition, a multidisciplinary effort.
b) Not all parties involved in conducting clinical research in the developing world abide by the ICH GCP standard. Since the majority of sponsors will demand this standard to be met, a clinical research organization working in such a context will have to facilitate, for example, the local ethical committees, laboratories, or the local pharmaceutical representatives in working as closely with ICH GCP as possible. Often ad hoc consultation and education sessions and administrative improvisation will be required.
c) Sponsors want to be convinced first of the likelihood of a study being conducted in accordance with ICH GCP. Sites needs to invest more time in interaction and negotiations with the sponsors prior to a study. HIV-NAT has recognized the need to invest more time in sponsor site visits and accepts that HIV-NAT studies, for the time being, are more likely to be audited by the sponsor.
d) The uncertainty regarding follow-up medication for many study participants forces HIV-NAT to maintain active negotiations with the sponsors and other parties involved on this issue.
7) In addition to Thailands economic reality, limited access to anti HIVdrugs in Thailand is due to a relatively slow registration process of newly available anti-HIV agents, relatively long and often unpredictable regulatory approval procedures, and a sometimes passive attitude on the part of some local pharmaceutical company representatives. HIV-NAT has learned that by initiating studies in collaboration with the companies international headquarters, the local representatives are forced into a pro-active import approach. Through HIV-NATs research activities and by generating local data which are ethnically applicable, pressure is being exerted on government agencies, regulatory authorities and ethical committees to re-evaluate their tasks and performance in the areas of HIV care, clinical research and importation and provision of drugs.
8) Given the predominance of the English language in HIV clinical research and in doing business with the sponsors, having staff members available who are fluent in English is essential.
9) Despite the tremendous human resources and know-how available within the three founding organizations, few of its staff have a managerial or financial background. Involving a consultant with such a background to write a business plan for HIV-NAT has proven very useful. Rather than focussing on scientific study content, the consultants focus is on management issues, long-term potential, and accountability of resources from an outsiders perspective. Such observations and experience have initiated a managerial and logistical streamlining at HIV-NAT.
10) Maintaining an open and ongoing communication structure within the organization and with study participants, our collaborators and the study sponsors benefits all parties involved.