Critical assessment of international clinical development programmes for new antihypertensive drugs.
Criteria for assessing new antihypertensive drugs: The major factors to be assessed when registering a new antihypertensive drug are chemical quality, drug efficacy, safety and tolerability in the short and long term. Critical criteria for acceptance of the drug may include the degree of originality, the validity of the dose range and administration schedule and the degree of usefulness compared with other drugs used in the same patient group. Future clincial development: The clinical development of new antihypertensive drugs is becoming increasingly complex. Similar errors are repeated from one clinical development programme to another. Simple but original protocols, using average rather than closely selected patient sets, and clearcut dose-ranging studies will reflect a better use of human and financial resources.
Ménard
J
J
Clinical Investigation Centre, INSERM-Assistance Publique, Paris, France.
D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic / Q000379:methods; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D017277:Drug Approval; D015507:Drugs, Investigational; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007391:International Cooperation; D012449:Safety
D000959:Antihypertensive Agents; D015507:Drugs, Investigational