 "CNS drug research: A dilemma for big pharma companies")
The most complicated area of clinical research post 2013 is the central nervous system (CNS). Big pharmaceutical companies are keen on investing in this therapeutic area. However their research and development (R&D) spends have yet to be rewarded with the desired clinical trial results. R&D in this therapeutic area is risky and chances of approval of these drugs by the regulatory authorities are very slim. This puts big pharmaceutical companies at the risk of major losses.
Central nervous system disorders bear an economic burden of more than $ 2 trillion in the US and EU and rake in upwards of $ 80 billion a year for the pharmaceutical industry.
The costs of clinical development for developing a CNS drug versus a cardiovascular drug is 30 percent higher and the chances of a CNS drug reaching a blockbuster status in the market is nearly 50 percent lower.
Research and development investments by big pharmaceutical companies in diseases such as Alzheimer’s, Parkinson’s, depression, anxiety, schizophrenia and stroke have invited the risks of heavy investments with little guarantee of success.
Two recent articles in Lancet Neurology and Nature Reviews Neurology looked at the reasons behind recent clinical trial failures, one article looked at neuroprotective therapies for Parkinson’s disease and the other looked at clinical trials in amyotrophic lateral sclerosis. Both diseases however share the fact they are caused by degeneration of the brain, although in different parts of the brain. Indeed the entire field of CNS disorders is characterised with failed trials and poorly treated conditions.
Phase III failures: A characteristic of CNS drug research
Clinical research in the arena of the central nervous system has nearly 25 percent of drugs in the phases II and III stages where the associated risks of drug failure are the highest. Clinical trials in the CNS therapeutic area are listed for nearly 650 indications.
Avenues for CNS research are the highest in North America and Europe. The emerging markets of South America, Asia, Australia and MENA are also recording clinical trial registrations.
Table: CNS clinical trials by start date
Out of the 22697 CNS clinical trials registered at the clinicaltrials.gov website, almost 45 percent of those have been registered based on their start date in the years 2011-2015. Most of these trials are in the phase II-phase IV stage. Very drugs are under development in the phase 0-phase I stage which is indicative that global pharmaceutical companies R&D investments in this area are very scarce owing to the numerous challenges faced during patient recruitment.
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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
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Central nervous system disorders bear an economic burden of more than $ 2 trillion in the US and EU and rake in upwards of $ 80 billion a year for the pharmaceutical industry.
The costs of clinical development for developing a CNS drug versus a cardiovascular drug is 30 percent higher and the chances of a CNS drug reaching a blockbuster status in the market is nearly 50 percent lower.
Research and development investments by big pharmaceutical companies in diseases such as Alzheimer’s, Parkinson’s, depression, anxiety, schizophrenia and stroke have invited the risks of heavy investments with little guarantee of success.
Two recent articles in Lancet Neurology and Nature Reviews Neurology looked at the reasons behind recent clinical trial failures, one article looked at neuroprotective therapies for Parkinson’s disease and the other looked at clinical trials in amyotrophic lateral sclerosis. Both diseases however share the fact they are caused by degeneration of the brain, although in different parts of the brain. Indeed the entire field of CNS disorders is characterised with failed trials and poorly treated conditions.
Rashmi Pant
- Incomplete knowledge of the biology of the disease
- This then leads to a lack of biomarkers, animal models that are not an accurate reflection of the disease and rating scales that are insensitive to detecting change over the time frame required for a clinical trial
- These areas coupled with inaccurate diagnosis and the difficulty of achieving homogenous populations within a lot of these CNS diseases have been the lessons learned from these negative clinical trials. There is a huge need for effective medicines to treat patients with CNS disorders. This need often means that there is pressure to move quickly from hypothesis to proof in pivotal clinical trials.
- Clinical trials involving disorders of the brain are notoriously difficult to set up and run
Phase III failures: A characteristic of CNS drug research
Graph 1: Number of CNS clinical trials by phase
Clinical research in the arena of the central nervous system has nearly 25 percent of drugs in the phases II and III stages where the associated risks of drug failure are the highest. Clinical trials in the CNS therapeutic area are listed for nearly 650 indications.
Avenues for CNS research are the highest in North America and Europe. The emerging markets of South America, Asia, Australia and MENA are also recording clinical trial registrations.
Table: CNS clinical trials by start date
| Years | No. of trials |
| 2010 | 1698 |
| 2011 | 1744 |
| 2012 | 1713 |
| 2013 | 1711 |
| 2014 | 1655 |
| 2015 | 1271 |
Out of the 22697 CNS clinical trials registered at the clinicaltrials.gov website, almost 45 percent of those have been registered based on their start date in the years 2011-2015. Most of these trials are in the phase II-phase IV stage. Very drugs are under development in the phase 0-phase I stage which is indicative that global pharmaceutical companies R&D investments in this area are very scarce owing to the numerous challenges faced during patient recruitment.
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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
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Graph 2: Clinical trials for top 16 CNS conditions