Issue 10 / 19 March 2012

FUNDING for medical research should be more supportive of research that is relevant and valuable to clinical practice, according to researchers writing in the latest issue of the MJA. (1)

The researchers said that the “reputation of researchers and the science that they generate has been tainted by methodological shortcomings, commercial influences, neglect of societal needs, and notorious cases of outright fraud”.

“Researchers need to be more proactive in evaluating clinical interventions in terms of patient-important benefit, wide applicability and comparative effectiveness”, wrote Associate Professor Ian Scott, of the department of internal medicine and clinical epidemiology at the Princess Alexandra Hospital, Brisbane, and Professor Paul Glasziou, of the centre for research in evidence-based research at Bond University on the Gold Coast, who also works part time as a GP.

In the article they questioned the relevance and value of much of the research that is currently available to guide practice and put forward recommendations that would ensure clinical practice had access to the best available evidence.

“The clinical research agenda is becoming increasingly distorted by commercial and academic priorities and pressures that do not match the concerns and needs of patients and clinicians”, they wrote.

An example was funding for trials targeting cardiovascular disease and cancer, which was “considerably greater” than the funding available for conditions with a similar or larger disease burden, such as musculoskeletal disorders, diabetes, injury, asthma and mental illness.

An added problem was that preference was given to manufactured products, such as drugs, rather than to potentially efficacious non-drug and other interventions. Trials also excluded large groups of patients such as the elderly, children and people with multiple comorbidities, leading to the problem of off-label use and potential harm.

The authors suggested that consumers, as well as practising clinicians, should be consulted to help identify and promote priorities for therapeutic research.

They also suggested increased funding be available from research agencies such as the NHMRC for independent investigator-led applied clinical research — rather than basic science.

“Although industry investment in trials is important, an appropriate level of public sector investment must coexist, to support independent research aimed at improving care and not solely producing marketable interventions”, the authors wrote.

A spokesperson for the NHMRC, which administers government funding for health and medical research, told MJA InSight the majority of research it supported was investigator initiated.

“NHMRC funds research on the basis of scientific excellence through competitive peer review mechanisms”, the spokesperson said.

The research expenditure reflected Australia’s health burden, with the most substantial support going to research into cancer, cardiovascular disease, diabetes and mental health.

Other issues addressed in the MJA article included shortcomings in trial design and reporting, diminishing returns from clinical research, restricted access to trial data, and the need for a federal government-funded central agency to collate and, when necessary, sponsor reviews and appraisals of health care technologies seeking public funding.

“It is estimated that less than 7% of all reported clinical trials are valid and highly relevant to clinical practice”, the authors wrote.

Many industry-funded trials were increasingly resorting to inflating event rates from new therapies or were involved in “me too” drugs that were reporting trivial gains in patient benefits.

“Researcher funders and grant reviewers should prioritise new research protocols according to (i) extent to which protocols target disease burden (death or disability); (ii) clinical importance of hypothesised effect or impact of study intervention; and (iii) likely feasibility and affordability of interventions in routine practice”, they wrote.

“Funders need to be more supportive of applied clinical research that rigorously evaluates effectiveness of new treatments and synthesises existing knowledge into clinically useful systematic reviews.”

The NHMRC spokesperson said that as part of its peer-review process, the NHMRC assessed clinical impacts — such as the health effect of new ideas, procedures, technologies, programs and health policy settings — in relation to the aims of the research.

– Kath Ryan

1. MJA 2012; 196: 304-308

Posted 19 March 2012

The MJA will host the MJA Clinical Trials Research Summit at the University of Sydney on 18 May. The theme for the summit is investigator-initiated clinical trials.

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