In the 19th century, James Parkinson wrote an essay describing a condition that is now known as Parkinson’s Disease. It is believed that various individual symptoms of the disease had been previously documented throughout history without being recognized as part of a broader disease state. Jean-Martin Charcot, known as the “founder of modern neurology”, built on James Parkinson’s work and distinguished Parkinson’s Disease from multiple sclerosis and other disorders characterized by tremors.
According to the Michael J. Fox Foundation for Parkinson’s Research, Parkinson’s disease (PD) occurs when brain cells that make dopamine, a chemical that coordinates movement, stop working or die. Because PD can cause tremor, slowness, stiffness, and walking and balance problems, it is called a “movement disorder.”1
Today society in general, and the life sciences industry in particular, recognize the symptoms and challenges and continue awareness and educational efforts around Parkinson’s Disease. The month of April has been designated as Parkinson’s Awareness Month.
The neurodegenerative disorder is characterized by the slow progression of symptoms over years. There is currently no cure but there are treatment options that include medicine or surgery.
Approximately 60,000 Americans are diagnosed with PD each year and more than 10 million people worldwide are living with PD. The Parkinson’s Foundation notes that the combined direct and indirect cost of Parkinson’s, including treatment, social security payments and lost income, is estimated to be nearly $52 billion per year in the United States alone.2
A recent search of clinicaltrials.gov resulted in 678 clinical trials (recruiting, enrolling by invitation, or active but not recruiting) in PD and more than 6,000 in Central Nervous System (CNS)-related research as of 3/30/2021. The studies include a wide range of therapies and treatment, including the use of stem cells and gene therapy. The potential research developments are exciting, but all require further investigation – and the participation of patients.
The human brain is complex. Trials in the CNS therapeutic area are also complex, often studying cognitive, motor, behavioral, linguistic, and executive functioning. The variability of symptoms across patients and the slow progression of Parkinson’s Disease intensifies these challenges that are typically associated with CNS clinical research.
Earlier this year, Mednet published Clinical Trial Trends and Predictions for 2021, a blog where we suggested that the complexity of clinical trials would continue to grow and that the need for simple, user-friendly technologies that afford greater flexibility and speed would dominate the clinical technology marketplace. We are seeing these predictions borne out in therapeutic areas such as CNS. These continuing requirements are paramount to Parkinson’s Disease research and will continue to drive technology decisions of clinical research teams for the foreseeable future.
The complexity and length of the trials inherently requires flexibility. Teams looking for biomarkers and employing different signal detection strategies over long trials must have the flexibility to adapt as required by changing circumstances. However, the required flexibility cannot be attained at the cost of simplicity. As trials designs become more complex, it is imperative that underlying technologies minimize the complexity for teams conducting the research. Simplicity and flexibility help teams to unleash innovation and ask different and better questions more efficiently.
At Mednet, we are committed to Achieving Broad Flexibility and Deep Functionality in Clinical Trial Technology. We understand how flexibility fosters innovation by enabling emerging capabilities. By loosening traditional technology constraints, we are empowering research teams. We also understand how important this is to a wide range of therapeutic areas, including CNS research.
In recognition of Parkinson’s Disease Awareness Month, Mednet launched a new program to support research organizations conducting Parkinson’s Disease (PD) research or any type of central nervous system (CNS) studies. To learn more about the program, Mednet’s platform or therapeutic expertise, contact us.