RESEARCH WASTAGE: INDUSTRY VERSUS ACADEMIC SPONSORSHIP
The commentary by Glasziou and Chalmers 1 and the response on medical student research 2 raise some important issues that need active management to prevent the impact of poor and wasted research on patient safety and medical training, not to mention the colossal drainage of societal funds in the region of $85 Billion 1. What is even more intriguing is that contrary to common belief, academic research appears to be even more culpable than research funded by Industry as indicated by the Trial Tracker established at the Oxford Centre for Evidence Based Medicine.
Research sponsored by the Pharmaceutical Industry has rightly received considerable scrutiny over the years and several improvements have been seen, especially in the area of trial registration and publication of negative trials. But many of the areas on which the Industry has received scrutiny also applies equally to all forms of research, including academic research. One could even argue that since Academic research is not under the stringent regulatory oversight of Industry research, the slippery slope towards wastage can be even greater. As we argued before 3, the reason Industry funded research has been shown to have more positive trial-based outcomes could be due to the extraordinary preparation that goes before embarking on large scale clinical trials not only because of the regulatory scrutiny but also paradoxically due to economic reasons to maximise the chances of the trail meeting its primary objective. These include preparatory preclinical work, ensuring that heavy investments into large scale clinical programs are only made after the demonstration of Proof of Concept in smaller trials with stringent GO/NO Go criteria and the statistical rigour that goes into power calculations and establishment of the primary end points.
The need to declare Conflicts of Interests has almost always been restricted to potential commercial conflicts. But is it time to recognise other personal and academic conflicts that could drive wasted research? The pressure to “publish or perish”, which was primarily a phenomenon seen in North America many decades ago, has now become a global phenomenon that not only applies to many academics in low-middle income countries but worryingly has encroached the arena of undergraduate medical students and postgraduate trainees. Would the drive for academic promotions and the inclusion of academics as co-authors in student driven research be considered as examples of such conflicts?
References:
1.Glasziou P & Chalmers I. Research waste is still a scandal – an essay by Paul Glasziou and Ian Chalmers. BMJ.2018; 363: k4645
2. Sharp EW & Curlewis K. Research waste is still a scandal – especially in medical students BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4645
3. Qizilbash N, Rockhold F & Sreeharan N. Industry sponsored trials; an alternative view. BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7358.249
Competing interests:
None to declare. But my views are influenced by my positions as Professor of Medicine, Sri Lanka (low-middle income country), and Senior Vice President and European Medical Director, GlaxoSmithKline R&D (Pharmaceutical Industry)
23 November 2018
Nadarajah Sreeharan
Visiting Professor
University of Jaffna, Sri Lanka & Kings College, London
Department of Clinical Medicine, University of Jaffna, Sri Lanka
Rapid Response:
RESEARCH WASTAGE: INDUSTRY VERSUS ACADEMIC SPONSORSHIP
The commentary by Glasziou and Chalmers 1 and the response on medical student research 2 raise some important issues that need active management to prevent the impact of poor and wasted research on patient safety and medical training, not to mention the colossal drainage of societal funds in the region of $85 Billion 1. What is even more intriguing is that contrary to common belief, academic research appears to be even more culpable than research funded by Industry as indicated by the Trial Tracker established at the Oxford Centre for Evidence Based Medicine.
Research sponsored by the Pharmaceutical Industry has rightly received considerable scrutiny over the years and several improvements have been seen, especially in the area of trial registration and publication of negative trials. But many of the areas on which the Industry has received scrutiny also applies equally to all forms of research, including academic research. One could even argue that since Academic research is not under the stringent regulatory oversight of Industry research, the slippery slope towards wastage can be even greater. As we argued before 3, the reason Industry funded research has been shown to have more positive trial-based outcomes could be due to the extraordinary preparation that goes before embarking on large scale clinical trials not only because of the regulatory scrutiny but also paradoxically due to economic reasons to maximise the chances of the trail meeting its primary objective. These include preparatory preclinical work, ensuring that heavy investments into large scale clinical programs are only made after the demonstration of Proof of Concept in smaller trials with stringent GO/NO Go criteria and the statistical rigour that goes into power calculations and establishment of the primary end points.
The need to declare Conflicts of Interests has almost always been restricted to potential commercial conflicts. But is it time to recognise other personal and academic conflicts that could drive wasted research? The pressure to “publish or perish”, which was primarily a phenomenon seen in North America many decades ago, has now become a global phenomenon that not only applies to many academics in low-middle income countries but worryingly has encroached the arena of undergraduate medical students and postgraduate trainees. Would the drive for academic promotions and the inclusion of academics as co-authors in student driven research be considered as examples of such conflicts?
References:
1.Glasziou P & Chalmers I. Research waste is still a scandal – an essay by Paul Glasziou and Ian Chalmers. BMJ.2018; 363: k4645
2. Sharp EW & Curlewis K. Research waste is still a scandal – especially in medical students BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4645
3. Qizilbash N, Rockhold F & Sreeharan N. Industry sponsored trials; an alternative view. BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7358.249
Competing interests: None to declare. But my views are influenced by my positions as Professor of Medicine, Sri Lanka (low-middle income country), and Senior Vice President and European Medical Director, GlaxoSmithKline R&D (Pharmaceutical Industry)