I read the editorial ‘Clinical Trials: what a waste’ by J Ioannidis with interest.
He has discussed reasons for aborted clinical trials at various stages of gestation. I think the reason for the biggest waste is due to desperate repeated attempts with same methods to prove something which has previously not convincingly demonstrated to be true, for example vitamin D supplementation trials.
It is fashionable to carry out vitamin D supplementation clinical trials, if one dose does not work higher or lower doses with various different preparations and frequency with or without calcium are conducted. Vitamin D is presumed to be a panacea for all known adult chronic medical conditions even though multiple meta-analyses have indicated otherwise. That is the reason U.S. Preventive Services Task Force has stated that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement) 1. Vitamin D and/or calcium supplementation also showed no overall effect on cardiovascular disease, cancer, and mortality 2.
The danger of such a practice could be that you are not only wasting money and time but end up bringing harm to the patient. Vitamin D is used to induce calcification of wall of the vessels in mice experiments. However, more and more cash is still being thrown on vitamin D supplementation clinical trials because of strong personalities, vested interests and a deep belief that one day it will be proven true. Instead it is possible that if studies on vitamin D were conducted with a different fresh perspective then it might be not only be beneficial to patients but lot of monies could be saved 3.
This principle could be applicable to various other useless but trendy clinical trials.
Reference List
(1) LeFevre ML. Screening for Vitamin D Deficiency in Adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2014.
(2) Fortmann SP, Burda BU, Senger CA, Lin JS, Beil TL, O'Connor E et al. 2013.
(3) Kain K. Circulation. In press 2015.
Rapid Response:
I read the editorial ‘Clinical Trials: what a waste’ by J Ioannidis with interest.
He has discussed reasons for aborted clinical trials at various stages of gestation. I think the reason for the biggest waste is due to desperate repeated attempts with same methods to prove something which has previously not convincingly demonstrated to be true, for example vitamin D supplementation trials.
It is fashionable to carry out vitamin D supplementation clinical trials, if one dose does not work higher or lower doses with various different preparations and frequency with or without calcium are conducted. Vitamin D is presumed to be a panacea for all known adult chronic medical conditions even though multiple meta-analyses have indicated otherwise. That is the reason U.S. Preventive Services Task Force has stated that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement) 1. Vitamin D and/or calcium supplementation also showed no overall effect on cardiovascular disease, cancer, and mortality 2.
The danger of such a practice could be that you are not only wasting money and time but end up bringing harm to the patient. Vitamin D is used to induce calcification of wall of the vessels in mice experiments. However, more and more cash is still being thrown on vitamin D supplementation clinical trials because of strong personalities, vested interests and a deep belief that one day it will be proven true. Instead it is possible that if studies on vitamin D were conducted with a different fresh perspective then it might be not only be beneficial to patients but lot of monies could be saved 3.
This principle could be applicable to various other useless but trendy clinical trials.
Reference List
(1) LeFevre ML. Screening for Vitamin D Deficiency in Adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2014.
(2) Fortmann SP, Burda BU, Senger CA, Lin JS, Beil TL, O'Connor E et al. 2013.
(3) Kain K. Circulation. In press 2015.
Competing interests: No competing interests