+ Site Statistics
+ Resolve Accession
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
Submit PDF Full TextSubmit PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on Google+Follow on Google+
Follow on LinkedInFollow on LinkedIn

+ Translate

The Lugano statements on controlled clinical trials

, : The Lugano statements on controlled clinical trials. Journal of International Medical Research 15(1): 2-22

During a consensus conference in Lugano, Switzerland, 175 statements on controlled clinical trials were drafted by 47 representatives from academia, governmental registration agencies and industry in nine countries. Their opinion on these statements was similar to that of 47 'matched pairs' who did not attend the conference. Thus, the opinion of participants and non-participants appears to reflect the general opinion of those currently involved in designing, conducting and analysing controlled clinical trials. The Lugano statements give answers to the following questions: Is the controlled clinical trial in a crisis? What is the motivation to perform controlled clinical trials? Is it possible for a physician participating in a controlled clinical trial to act in the patient's best interest? Is it possible to obtain truly informed consent in a controlled clinical trial? When is it ethical to withhold active treatment in a controlled clinical trial? What are the controversial issues in the design of a good controlled clinical trial? Is there a double standard with respect to efficacy and adverse drug reactions in controlled clinical trials? What are the alternatives to controlled clinical trials and when should they be performed? How can sponsor bias be minimized? How should an ethics committee decide whether a controlled clinical trial is ethical? Should registration agencies become directly involved in the planning and conduct of controlled clinical trials? Do the declarations of Tokyo and Helsinki facilitate the conduct of ethically valid controlled clinical trials? Is it possible to create an international standard for the conduct and regulation of controlled clinical trials? Why do messages from controlled clinical trials filter into medicine so slowly? Is it possible to bridge the gap between controlled clinical trials and clinical reality? What are the costs of doing and not doing controlled clinical trials? When should drug companies decide to start a trial programme with a specific compound? Is there public hostility against controlled clinical trials? If so, how can it be reduced? The respondents almost unanimously felt that controlled clinical trials are a must: the public must be told that progress in medicine depends on controlled clinical trials, that patients often benefit from participating in them and that the alternative, practising in the face of constant uncertainty, is worse than the possible disadvantages related to the conduct of the trial.

(PDF 0-2 workdays service)

Order PDF Full Text


Click here to order any other PDF Full Text

Accession: 006712341

PMID: 3817279

PDF Full Text: Submit

Submit PDF Full Text

No spam - Every submission is manually reviewed

Due to poor quality, we do not accept files from Researchgate

Submitted PDF Full Texts will always be free for everyone
(We only charge for PDFs that we need to acquire)

Select a PDF file:

Other references

Tambad, S. B.; Patel, K. V., 1970: Crop yield index as measure of productivity. Different concepts of productivity are discussed and two methods of constructing a crop yield index are recommended. One method gives the crop yield index of a given farm with respect to a given region, while the other is for the comparable indice...

Kailasnath, P.; Chaloupka, J.C., 1996: Mathematical modeling of AVM physiology using compartmental network analysis: theoretical considerations and preliminary in vivo validation using a previously developed animal model. The development of computer modeling technique of cerebral arteriovenous malformations using circuit network analysis, validated with a previously developed animal model is presented. Such a malformation and its vascular connections are rendered i...

WINICK, C., 1965: Process And Interaction In Group Psychotherapy. Topical Problems of PsychoTherapy 5(): 67-71

Dickerson A.G.; Baker R.C.F., 1979: The binding of enzymes to fungal beta glucans. Purified preparations of the extracellular glucan of Sphacelia sorghi and the walls of Claviceps purpurea contain enzymically active protein. The glucans and walls were treated in various ways to liberate the protein and determine the nature and s...

Lemetayer, E.; Nicol, L.; Girard, O.; Corvazier, R.; Cheyroux, M., 1950: Absorption through the digestive tract of heterologous antitoxins from milk. Three foals, aged 8 days, 18 days and 8 weeks, were given half a litre of cow's milk daily for six days. The serum of the cow supplying the milk contained half a unit of natural tetanus antitoxin per cu. mm. No rise in the foals' serum t...

Switkes E.; Bradley A.; Schor C., 1990: Readily visible changes in color contrast are insufficient to stimulate accommodation. In an earlier study (Wolfe and Owens, 1981) it was reported that humans could not accommodate to an insoluminant red-green border. However, recent masking studies (Switkes, Bradley and DeValois, 1988) have shown that, using an appropriately normal...

Anderson, G.; Thomas, G.; Stewart-Jones, J., 1977: Treatment of advanced bronchogenic carcinoma with adriamycin 5 fluoro uracil and methotrexate. The combination of adriamycin, 5-fluorouracil and methotrexate with folinic acid reversal was used to treat patients with advanced bronchogenic carcinoma. Twenty-one of 30 patients showed an objective response. This combination appears to produce...

Dreux, P., 1988: Les deplacements d'especes dans les iles subantarctiques de l'Ocean Indien. Bulletin de la Societe Zoologique de France. 1987 ; 1123-4: 471-481

Bagyaraj D.J.; Rangaswami G., 1972: Studies on the rhizosphere micro flora of eleusine coracana under the influence of foliar chemical sprays part 1 quantitative incidence of microorganisms. Madras Agricultural Journal 59(9-10): 517-523

Murthy, S.; Flanigan, A.; Osborne, B.; Grossmann, A.; Bishop, P., 1999: Recombinant factor XIII attenuates dextran sulfate -induced colitis in mice. Gastroenterology 116(4 PART 2): A780, April