Page 26 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

SPECIFIC PRINCIPLES

10. I DRUG TRIALS

A clinical trial is a systematic study of new drug(s) in human subject to
generate data for discovering and / or verifying the clinical,
pharmacological (including pharmacodynamic and pharmacokinetics), and
/ or adverse effects with the objective of determining the safety and/or
efficacy of the new drugs. For new drugs, adequate evidence derived from
animal studies must be available to ensure and toxicity prior to conducting
a study in humans. It is designed to evaluate the safety and effectiveness
of new drugs/ new formulations prospectively. A new drug may be defined
as:
i. a new chemical entity (NCE);
ii. a drug which has been approved for a certain indication, by a
certain route, in a certain dosage regimen, but which is now
proposed to be used for another indication by another route or in
another dosage regimen;

iii. a combination of two or more drugs which, although approved
individually, are proposed to be combined for the first time in a
fixed dose combination (FDC).

The proposed trial should be carried out only after approval of the
Directorate General of Drug Administration (DGDA). All the guiding
principles should be followed irrespective of whether the drug has been
developed in this country or abroad or whether clinical trials have been
carried out outside Bangladesh or not.

The difference between therapy and research should be maintained
throughout the drug trials. A physician /investigator who run the new drug
trial should ensure during consent that the patients have adequate
understanding that the drug is experimental and its benefits for the
condition under study are yet not proven.

10.1.1 Special considerations

i. It is extremely debatable to use placebo in drug trials and
sham surgery in clinical trials. Each protocol using placebo needs
very careful consideration before approval. Denial of the available
treatment to control (placebo) group of patients is unethical.

ii. Trials of drugs without the approval of the DGDA and
appropriate agencies should be dealt with according to the law of
the land.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 22