Page 28 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

reporting procedures and should be strictly adhered to while
carrying out a trial.

The clinical trials usually are of 3 types –
i. studies where intervention is clearly “demarcated research”
such as phase I trial of a new compound;

ii. studies with a mix of standard medical practices and
specific research elements, e.g. trials of two competing anti-
nausea drugs following standard chemotherapy;
iii. studies involving research on therapeutic practices, such as
the trial of two already approved anti-diabetic drugs.

10.1.2 Phases of Clinical Trials

All phases require approval from EC. The first three of the
following four phases of clinical trials of drug require DGDA's
clearance:

Phase I (Human Pharmacology) This is a first-in-human trial
using a new chemical entity that is usually conducted in healthy
volunteers to study acute toxicity and safety that is associated with
the dose range of the drug. Because of drug side effects, the study
should be conducted in well-equipped facilities in the hospital, and
should not be conducted in children, the elderly and women with
childbearing potential. Anesthesia or anticancer drugs should not
be used in the healthy volunteers as a result of its high toxicity.
Approximately, the number of the subjects should not exceed 30.
Every subject should give a written informed consent before
participating in the study. The study in this phase is usually an
open study without any control group i.e., both subjects and
investigators know the trial drug.

At least two participants should be administered each dose to
establish the safe dose range with their intensity and nature. It is
safer to start trial from the lowest dose, which can be increased to
higher doses only after the safety of the lower doses is evidently
established. Pharmacokinetics i.e. characterization of a drug’s
absorption, distribution, metabolism and excretion (ADME), should
be performed to support formulation development and determine
pharmacokinetic parameters in different age groups to support
dosing recommendations considering patients with impaired
elimination (renal or hepatic failure), and ethnic subgroups.

Investigator trained in clinical pharmacology should preferably
carry out these studies. The duration of time lapsing between two
trials in the same volunteer should be a minimum of 3 months and

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 24