We need better animal research, better reported
BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k124 (Published 11 January 2018) Cite this as: BMJ 2018;360:k124
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Dear Editor,
Thank you to Deborah Cohen for their comprehensive article and Merel Ritskes-Hoitinga and Malcolm Macleod for their accompanying editorials.
I am sure I am not the only clinician who has had to reconcile their adverse feelings towards vivisection with the desire to provide the best care for patients. However, I was horrified to read of the inadequate research methods of the MVA85A animal studies the authors report. Furthermore, the fact these data went on to underpin a clinical trial in a vulnerable, non-white patient population is an additional disappointment.
Although there is rigorous UK legislation in the form of the Animals (Scientific Procedures) Act 1986 to ensure animals used in research are treated as ethically as possible, this seems redundant when the methodological processes underpinning the experiments are so poor. I wonder if this is something researchers recognise and are actively trying to change or if it has become an cultural norm.
I accept that animal experiments, despite their limitations, currently are an integral part of pre-clinical trials to test both treatment concepts and safety. However, a move towards research methods focused on human biology, as proposed by the Safer Medicines Campaign, would hopefully result in better translational data and a reduction in animal suffering. However, I can appreciate how exploring novel techniques may be a challenge in the current climate where public funding for scientific research continues to be cut.
Animal experimentation can only be justified with robust methodology and I welcome the authors suggestions to improve the design, registration, reporting and transparency of animal studies. Hopefully this will lead to less unnecessary animal suffering and safer, more effective treatments for patients.
Competing interests: No competing interests
Sir -
Fiona Godlee, in her editorial (BMJ 2018; 360:k124), seems to have swallowed a particular paper (that she has chosen to publish) hook line and sinker. In fact, as Editor, she should recognize her own limitations. She has no experience or expertise in vaccine development. Furthermore, she seems to have no insight that in all aspects of medicine, the small proportion of things that work in animals that can be demonstrated to also be effective in man, and the few product licences that result from some exponential multiple of early-phase human studies, let alone animal studies. There is nothing extraordinary about a failed mapping of animal studies to clinical trial results at all. Meanwhile, the suspicion is that the Editor will add this to her arsenal of anti-industry evidence by implying malfeasance where there is none.
Competing interests: No competing interests
Medical researches studies in animals are not 100% equivalent to human studies.
Research studies in animal species and strains, with a variety of metabolic pathways and drug metabolites, may lead to variation in efficacy and toxicity out come.
It may also required different models for inducing illness or injury, with varying similarity to the human condition.
And also In animal studies variable duration of follow-up, may not correspond to disease latency in humans.
So animal studies will only become more valid predictors of human reactions to exposures and treatments if there is substantial improvement in both their scientific methods as well as in more systematic review of the animal literature as it evolves.
Competing interests: No competing interests
Pre-clinical trials: Challenges to answer.
Preclinical trials are very important to develop new medicines to ease the suffering of mankind. It is the responsibility of all scholars to plan their pre-clinical trial to be globally accepted. The main challenges in preclinical studies are Improper Study design, Cost computability, Timeline, Lack of Knowledge of Pharmacovigilance.
Regulatory agencies must focus on the international and national laws and regulations where the preclinical trial is to be performed. Governing agencies like ethics committee approval before the study begins Consolidated Standards of Reporting Trials (CONSORT ) (1), Uniform Requirements for Manuscripts (URM) (2) must be part of it.
Funding is one of the main drawbacks of pre-clinical trials. Almost all preclinical studies are funded by pharma giants, and to develop one drug molecule around seventy percent of its total study budget is required for pre-clinical and clinical research. Other issues include the faintness of institutional ethics committees, pressure on academicians to get funded projects, and government policies like not supporting preclinical research (3)(4).
In the present scenario, it is very difficult to conduct preclinical trials as every preclinical study requires skilled manpower, including investigators and assessors for a better outcome.
After this, science puts forward one more step forward asking “ why”? What is the purpose and the mechanism? This answers many of the questions, especially in clinical research from reverse pharmacology to networking pharmacology. Over more than a few decades, elaborate attempts have been made in clinical research to develop standards, playing an important role in understanding the descriptive knowledge of an evidence-based reality.
References:
1. http://www.consort-statement.org
2. http://www.icmje.org/
3. http://www.rncos.com/Report/IM564.htm
4. Eleventh Five Year Plan (20072012) New Delhi: Oxford University Press; 2008. Social Sector: Volume II; Planning Commission, Government of India.
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Competing interests: No competing interests