Research studies andPregnancyRegulation for enrolling pregnant woman in studies
Regulatory Guidelines• ICH M3• GCP• FDA• Schedule Y
Schedule Y• Pregnant or nursing women1) Pregnant or nursing women should be included inclinical trials only when the drug is intended for useby pregnant/nursing women or fetuses/nursinginfants and where the data generated from womenwho are not pregnant or nursing, is not suitable.2) For new drugs intended for use during pregnancy,follow-up data (pertaining to a period appropriate forthat drug) on the pregnancy, foetus and child will berequired. Where applicable, excretion of the drug orits metabolites into human milk should be examinedand the infant should be monitored for predictedpharmacological effects of the drug.
FDA Regulation45 CFR Part 46(subpart B)Definition:-a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneousrespiratory activity, spontaneous movement of voluntary muscles, norpulsation of the umbilical cord.(b) Delivery means complete separation of the fetus from the woman byexpulsion or extraction or any other means.(c) Fetus means the product of conception from implantation until delivery.(d) Neonate means a newborn.(e) Nonviable neonate means a neonate after delivery that, although living, isnot viable.(f) Pregnancy encompasses the period of time from implantation untildelivery. A woman shall be assumed to be pregnant if she exhibits any of thepertinent presumptive signs of pregnancy, such as missed menses, until theresults of a pregnancy test are negative or until delivery.
Research involving pregnant womenPregnant women or fetuses may be involved in research if all of the followingconditions are met:(a) Where scientifically appropriate, preclinical studies, including studies on pregnantanimals, and clinical studies, including studies on non pregnant women, have beenconducted and provide data for assessing potential risks to pregnant women andfetuses;(b) The risk to the fetus is caused solely by interventions or procedures that hold outthe prospect of direct benefit for the woman or the fetus; or, if there is no suchprospect of benefit, the risk to the fetus is not greater than minimal and the purposeof the research is the development of important biomedical knowledge which cannotbe obtained by any other means;(c) Any risk is the least possible for achieving the objectives of the research;(d) If the research holds out the prospect of direct benefit to the pregnant woman, theprospect of a direct benefit both to the pregnant woman and the fetus, or no prospectof benefit for the woman nor the fetus when risk to the fetus is not greater thanminimal and the purpose of the research is the development of important biomedicalknowledge that cannot be obtained by any other means, her consent is obtained inaccord with the informed consent provisions of subpart A of this part;
Continue:-(e) If the research holds out the prospect of direct benefit solely to the fetusthen the consent of the pregnant woman and the father is obtained in accord with theinformed consent provisions of subpart A of this part, except that the fathers consentneed not be obtained if he is unable to consent because of unavailability,incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.(f) Each individual providing consent under paragraph (d) or (e) of thissection is fully informed regarding the reasonably foreseeable impact of the researchon the fetus or neonate;(g) For children as defined in §46.402(a) who are pregnant, assent andpermission are obtained in accord with the provisions of subpart D of this part;(h) No inducements, monetary or otherwise, will be offered to terminate apregnancy;(i) Individuals engaged in the research will have no part in any decisions asto the timing, method, or procedures used to terminate a pregnancy; and(j) Individuals engaged in the research will have no part in determining theviability of a neonate.
Pregnancy and Clinical studyThanking youPriti Gupta