Research management of new drug development: A feasibility study of the development of a fixed combination of DHE and heparin for the prophylaxis of postoperative deep vein thrombosis and pulmonary embolism

This investigation was conducted to determine the feasibility of developing a new combination pharmaceutical product (DHE/heparin) for the prevention of postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) in the United States.; In an evaluation from a management development point of view, an extensive search and review of the world literature and experiences in this area of research here and in West Germany where the product has been recently approved, formed the basis for the conclusions drawn from this study. These are namely: (1) There is a need for a greater awareness of the seriousness of the problem of DVT and PE by the medical community. (2) Preventive therapy is the only practical therapeutic approach to reducing the incidence of postoperative DVT and PE. (3) Routine prophylactic therapy for postoperative DVT and PE for patients over 40 years of age undergoing major general and orthopedic surgery could prevent 10,000 deaths per year due to these hazards of surgery in the United States. (4) Current clinical research experience supports a dual therapeutic approach to prevention of postoperative DVT and PE. The combination of DHE and heparin fulfills the need of counteracting the causative factors (venostasis and hypercoagulability) in postoperative DVT and PE. (5) The program designed as a result of this investigation for the development of the new combination products of DHE and heparin in the United States should be implemented as soon as possible.