PubMed · 12136805
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B H Lauterburg. 2002. [Phytotherapy].. https://doi.org/10.1024/0040-5930.59.6.265
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Incremental progress will likely continue to be made in the treatment of lung cancer using the conventional treatment modalities. However, there is now hope that the development of noncross-resistant modalities that can be accomplished using the technology of gene transfer may hasten the progress made in this disease. Although significant progress has been made, the practical application of the various strategies to the treatment of cancer patients in clinical trials has yielded only very limited results. For the strategies of introducing suicide genes, replacing defective tumor-suppressor genes, and inactivating oncogenes, considerable progress will need to be made particularly with regard to the ability of vectors to selectively and efficiently target tumor cells in order for many of these strategies to become effective. With regard to the application of gene therapy to immunotherapy, major responses are not likely at this time since these innovative therapies are being developed in patients with advanced disease. However, it is very likely that these pioneering clinical trials will provide important clinical and immunological information that will be the basis for future attempts to effectively harness the immune system against lung cancer.
Clinical trials have become critical to the advancement of medical science and to the evolution of patient care in medicine. The science of clinical research has advanced from early studies in which treatment was assessed without controls to sophisticated multinational collaborative randomized, double-blind, placebo controlled trials of therapeutic interventions. To facilitate the advancement of clinical research, clinical trials networks have been developed to conduct multicenter studies. This review describes the history of clinical trials, clinical trials networks, and the goals of such networks in the United States. The Cystic Fibrosis Therapeutics Development Network, a network that represents the paradigm for genetic and orphan diseases, is described in detail. This network has been extremely successful in its first 3.5 years of existence conducting 18 different clinical trials in patients with Cystic Fibrosis. Unique aspects of the network include the use of internet applications for study conduct and communication, the development of statistical methodology to enhance the efficiency of clinical trial design, the development of outcome measures specific to Cystic Fibrosis, and the development of infrastructure necessary for expediting protocol development. In the current environment, clinical research faces significant challenges related to ensuring the safe and ethical conduct of clinical research while promoting fast and efficient clinical trials. To succeed and move forward to provide treatments and find cures for diseases, clinical trials networks must continue to evolve. The Cystic Fibrosis Therapeutics Development Network represents a network that has met this challenge and will continue to provide a venue for the safe and efficient conduct of clinical trials in Cystic Fibrosis.
BACKGROUND: Gastrointestinal (GI) tract surgeons were challenged with the development of two revolutionary surgical specialities: laparoscopic and endoscopic surgery. Minimal access surgery currently is the surgical speciality with the greatest impact on patient care. Regarding the competitive treatment methods (open, laparoscopic, and intraluminal endoscopic management), each new treatment must be evaluated on the evidence of the patient's benefit, surgical morbidity, short- and long-term outcome, cost effectiveness and maintenance of quality of life. METHODS: On the basis of randomized clinical trials, minimal access surgery results in reduced postoperative pain, reduced early postoperative analgetic medication, reduced frequency of systemic inflammatory response syndrome and systemic complications, early restoration of normal bowel function, and minimalization of wounds and skin scars. Among the well-established laparoscopic procedures, laparoscopic cholecystectomy has been convincingly demonstrated as superior to open cholecystectomy on the basis of controlled clinical trials. Superior benefit in favor of laparoscopic hernia repair has been demonstrated only regarding a lower level of pain, a higher level of physical activity, and earlier return to work. However, in terms of operating time and costs, open repair without mesh has benefits. Laparoscopic appendectomy offers benefits in terms of pain reduction, faster postoperative recovery, and lower incidence of wound infections, but has major drawbacks with regard to longer operating time, higher local complication rates, and significantly higher costs for total hospitalization. A cost study group concluded from a randomized clinical trial that only minimal short-term quality-of-life benefits were found for laparoscopically assisted colon resection, as compared with standard open colectomy, for colon cancer. On the basis of controlled clinical trials, there is only a little doubt that the laparoscopic approach is currently the operative treatment of choice for gastroesophageal reflux compliance. Endoscopic intraluminal techniques are increasingly important for minimalization of surgical treatment. For ulcer bleedings, endoscopic treatment is the established first choice. A major old and new challenge for GI tract surgeons is the intraluminal endoscopic approach to lesions. For neoplastic lesion in the esophagus (> 2 cm, mucosa restricted), Barrett's epithelium, early gastric cancer, adenoma of the ampulla of Vater, T1+, TIM lesion of the large bowel, T1 cancer of the rectum, intraluminal endoscopic treatment methods are increasingly replacing open surgical resection or even a laparoscopic technique. The surgeon must be aware that many of the local surgical complications, particularly those of GI tract anastomoses, are managed by endoscopic techniques. CONCLUSIONS: The GI tract surgeon must accumulate competent endoscopic experience. His responsibility for GI diseases focuses on surgical treatment using minimal access surgical techniques including surgical endoscopy in preoperative, intraoperative, and postoperative settings. This major assignment is a challenge not only for GI tract surgeons in the near future.