Management of clinical trials in developing countries.

PIP: Clinical trials need to consider specifics in trial circumstances when novel measures to improve health call for assessment in developing countries. Predictions regarding safety and efficacy under regional conditions, deriving from data of trials in affected populations in another part of the world, cannot always be accepted as reliable indicators of future regional performance. The primary objective should be to reveal new information. This discussion of the management of clinical trials in developing countries focuses on the following: the protocol; staff and supervision; locations and logistics; the use of a pilot study; drugs and compliance; and ethics. At an initial workshop a planning group with the broadest possible representation draws up a protocol. Ideally, the protocol is never imposed but is developed through extensive consultation and coordination. Its initial objective is an agreement on how to make a specific study feasible. Initial goals should be restricted to answering a few simple but meaningful questions. Information in the study protocol includes: aims and objectives; precise definitions of clinical variables; detailed description plus frequency and timing of clinical procedures, laboratory tests, and so forth; case report forms; consent forms and any warning notices written in the local language; work manuals for the pharmacist of drug supervisor; the treatment allocation procedure and individual treatment charts; the labeling code, emergency code breaking, and referral procedures; precise guidelines for evaluation and management of known adverse reactions; and an investigational data brochure. Selection of a competent, dependable, and enthusiastic principal investigator, available for the full duration of the study is essential. Suitable trial sites should be carefully chosen to avoid conditions that might prevent application of adequate scientific standards. In case of doubt about the logistical feasibility, starting with a trial run of the test procedures or with a pilot study using an established drug should be considered in order to detect potential problems concerning availability of scientific and technical expertise, equipment or reagents. It is necessary to check national clearances for investigating new agents. Permits may be required from a review body, a manufacturer, or from an authority. All needed drug supplies should be obtained at once together with information on stability under expected storage conditions. An independent measure of patient compliance needs to be agreed upon. Projects should be reviewed as well as approved by an independent local group, practicing the highest standards of protection of the rights of the individual. Data collection begins with identification of subjects, by photographs of faces, in addition to careful records of name, household, domicile, and occupation.^ieng

An Asian perspective on drug and related health care information.

To ensure that drugs are available in adequate quantity and quality for the health needs of the population and properly used, Asian governments in the past decades have exercised their sovereign rights quite independently and differently. A high number of patients per prescribing physician has consequences for drug information, in regard to both prescribers and consumers needing to self-medicate. To reliably inform patients through physicians, pharmacists, or medical auxiliary personnel is of great importance in the face of an illiteracy problem. Self- medication and illiteracy place emphasis on communication by word of mouth or by pictures. Word of mouth is the most important route, because even with a steady increase in literacy, the increase in transistor radios has been even more pronounced. For specific health information, instructional posters, with emphasis on pictures, have been very effective. Billboards do not allow adequate information disclosure needed for drugs. The opportunity to expand the coverage of consumer drug information, in that labelling for consumers gives additional relevant general health information, seems appropriate.