{"id":41627,"date":"2018-03-13T13:26:09","date_gmt":"2018-03-13T12:26:09","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=41627"},"modified":"2018-03-19T11:50:46","modified_gmt":"2018-03-19T10:50:46","slug":"research-into-parkinsons-disease-needs-reform","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2018\/03\/13\/research-into-parkinsons-disease-needs-reform\/","title":{"rendered":"Ben Stecher et al: Research into Parkinson\u2019s Disease needs reform"},"content":{"rendered":"

\"\"<\/a>As Parkinson\u2019s Disease (PD) patients and research advocates, we remain hopeful that the whirlwind of research and translational studies which flood the pages of journals around the world will result in treatments that significantly improve quality of life for people with PD within our lifetime. While the Parkinson\u2019s community continues to wait, however, we must acknowledge a growing element of scepticism: the pace of novel advances seems to be slowed down by a system that can not move fast enough to keep up with our own neurodegeneration.<\/p>\n

The longer we wait, the more we wonder whether our hopes have been misplaced. Questions arise as to whether the current clinical trial model is suitable for a condition where no two cases are quite the same. While other fields\u2014such as oncology\u2014are pressing forward with targeted and individualized approaches, neurodegenerative research is languishing. The question of \u201cwhat treatment for which patient?\u201d seems to be lost in large multicenter trials designed to ask the overly simplistic and inappropriate question of \u201cwhat works beyond placebo for the average PD patient?\u201d The \u201caverage PD patient\u201d is a statistical construct rather than a physical entity.<\/span><\/p>\n

This clinical trial model\u2014built largely on conservative incremental refinements of current drugs to treat large groups of people\u2014seems ill-equipped to tackle PD where etiological heterogeneity is the rule rather than the exception. Also, as regulatory burdens grow at an increasing pace, and research-associated costs balloon, most phase III clinical trials are left in the hands of large pharmaceutical companies. These entities inherently consider not only therapeutic advance, but also the consequences of research on their revenue stream. Too often, these clinical trials seem to be conducted to support new patents rather than patients.<\/span><\/p>\n

For too long we have stood by and watched infighting between scientists and their funders over control<\/span>, lack of funding for replication studies<\/span>, potential for data hoarding<\/span>, or money wasted on studies in which the clinical significance is unclear.<\/span>\u00a0We have seen trials that are considered \u201csuccessful\u201d even though they offer little meaningful benefit to patients<\/span>, while witnessing the scientists driving research and novel discovery forward being forced to spend an increasing proportion of their time securing grants and, if successful, addressing the administrative requirements of funding agencies and regulatory bodies<\/span>\u00a0rather than their science. [1-9]<\/span>
\n<\/span><\/p>\n

We need to reform incentive structures to enable research scientists to work towards bigger goals than simply getting their names in high impact journals.<\/span> We want editors and reviewers to support replication studies and negative results so that excitement is not driven by chance-level findings. We need a system that can empower scientists to pursue ambitious research, that enables them to spend more time on their science and less on securing their next grant renewal, that does not force them to kowtow to flawed metrics like impact factor and H index, and that encourages them to work more closely with patient advocates to understand our priorities regarding appropriate assessments beyond the Unified Parkinson’s Disease Rating Scale (UPDRS) and beyond motor function. We need patient-scientist teams to work together to maximize the likelihood that studies are designed in a way that will ultimately best inform patient and clinician treatment decisions.<\/span><\/p>\n

As a first step towards ameliorating these problems, patients should become part of the clinical trial design process. Rather than just being told which hoops to jump through they should be recognized as partners in research. We remain hopeful that, through collaboration, outreach, mutual education, and ongoing communication, we can work together to bring us closer to the treatments we so desperately need. As the fastest growing neurological disease\u2014a \u201cParkinson Pandemic\u201d<\/span>\u2014<\/span>increased efficiency of the research infrastructure is more important than ever. [10] We ask that the scientists, publishers, charities, and public funding institutions committed to advancing research in PD join us in a push to adapt to the changes we need to embrace if we are going to make meaningful progress towards treating this disease.\u00a0<\/span><\/p>\n

Benjamin Stecher<\/strong> was an education consultant in China when he got diagnosed with Parkinson’s disease at age 29. Now 33 he travels extensively meeting experts to learn all that he can about this disease and communicating that on his site, tmrwedition.com. @Neuronologist1<\/em><\/p>\n

Karen G. Raphael<\/strong>\u00a0is Professor in Oral Medicine at the New York University College of Dentistry and in Psychiatry at the New York University School of Medicine, New York, NY. She has been living with Parkinson’s disease for 8 years.\u00a0<\/em><\/p>\n

Sara Riggare<\/strong> has been managing Parkinson\u2019s disease since her teens and is currently pursuing a doctorate in health informatics at Karolinska Institutet in Stockholm, Sweden.\u00a0<\/em><\/p>\n

Simon RW Stott<\/strong>\u00a0research associate at the John Van Geest Centre for Brain Repair, University of Cambridge. Conducting both lab and clinic-based research on Parkinson’s.\u00a0<\/em><\/p>\n

Competing interests<\/strong>: None declared.\u00a0<\/em><\/p>\n

Acknowledgments:<\/strong>\u00a0<\/strong>The authors would like to acknowledge the contributions made by\u00a0<\/span>Mariette Robijn, Martin Taylor, Jasmine Sturr, Megan Duffy,\u00a0and Prof. Andrew Lees.
\n<\/span><\/em>
\n<\/span>References:<\/strong><\/p>\n

    \n
  1. Piller C. As Parkinson\u2019s patients wait, Fox Foundation and scientist feud over drug trial <\/span>https:\/\/www.statnews.com\/2016\/08\/30\/parkinsons-study-fox-foundation-feud\/Aug<\/span><\/a> 30, 2016 [<\/span><\/li>\n
  2. Curtis MJ, Abernethy DR. Replication – why we need to publish our findings. <\/span>Pharmacol Res Perspect<\/span><\/i> 2015;3(4):e00164. doi: 10.1002\/prp2.164<\/span><\/li>\n
  3. Karczewski KJ, Tatonetti NP, Manrai AK, et al. Methods to Ensure the Reproducibility of Biomedical Research. <\/span>Pac Symp Biocomput<\/span><\/i> 2017;22:117-19. doi: 10.1142\/9789813207813_0012<\/span><\/li>\n
  4. Pahwa R, Hauser RA. ADS-5102 (Amantadine) Extended Release for Levodopa-Induced Dyskinesia. <\/span>JAMA Neurol<\/span><\/i> 2017;74(12):1507-08. doi: 10.1001\/jamaneurol.2017.3205<\/span><\/li>\n
  5. Ory-Magne F, Corvol JC, Azulay JP, et al. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. <\/span>Neurology<\/span><\/i> 2014;82(4):300-7. doi: 10.1212\/WNL.0000000000000050<\/span><\/li>\n
  6. Wolf E, Seppi K, Katzenschlager R, et al. Long-term antidyskinetic efficacy of amantadine in Parkinson’s disease. <\/span>Mov Disord<\/span><\/i> 2010;25(10):1357-63. doi: 10.1002\/mds.23034<\/span><\/li>\n
  7. Metman LV, Del Dotto P, LePoole K, et al. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. <\/span>Arch Neurol<\/span><\/i> 1999;56(11):1383-6.<\/span><\/li>\n
  8. Gad SC. Safety and regulatory requirements and challenge for CNS drug development. <\/span>Neurobiol Dis<\/span><\/i> 2014;61:39-46. doi: 10.1016\/j.nbd.2013.09.017<\/span><\/li>\n
  9. Robillard JM, Federico CA, Tairyan K, et al. Untapped ethical resources for neurodegeneration research. <\/span>BMC Med Ethics<\/span><\/i> 2011;12:9. doi: 10.1186\/1472-6939-12-9<\/span><\/li>\n
  10. Dorsey ER, Bloem BR. The Parkinson Pandemic-A Call to Action. <\/span>JAMA Neurol<\/span><\/i> 2017 doi: 10.1001\/jamaneurol.2017.3299<\/span><\/li>\n<\/ol>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    As Parkinson\u2019s Disease (PD) patients and research advocates, we remain hopeful that the whirlwind of research and translational studies which flood the pages of journals around the world will result […]<\/p>\n

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