Lack of Clinical Trials for Traumatic Brain Injuries

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Traumatic brain injuries (TBI) are arguably one of the most significant issues in public health prevention. In the United States, more than 2 million people sustain a TBI each year due to falls, motor vehicle accidents, sports injuries, violence, and combat injuries in the veteran community (Talsky et al., 2011). Twenty-five percent of people require hospitalization, leading to an approximate direct and indirect cost of $50-100 billion each year (Talsky et al., 2011). Although there have been some advances in brain injury research, such as the discovery of Chronic traumatic encephalopathy (CTE) and assessing the TBI outcomes across sex in veterans, the National Institute of Health estimates that 2.5 to 6 millions Americans currently struggle with TBI-related disabilities (Talsky et al., 2011). Not only is there no standard of care for people with traumatic brain injuries, but clinical trials to categorize and understand the pathology and symptoms of post-traumatic brain injury are scarce. 

Why does this happen?

Promising therapeutics have failed to translate these findings into TBI clinical practice (Cox, Juranek, and Bedi, 2019). Researchers have primarily identified the categorization and classification of TBIs in clinical research as problematic and the primary reason why there is a lack of clinical trials (Cox, Juranek, and Bedi, 2019). Most clinical trial research utilizes the Glasgow Outcome Score (GOS) to classify TBI severity. The Glasgow Outcome Score problematically fails to “distinguish the truly bad from the truly good clinical trajectories at the time of [TBI] presentation with enough fidelity to perform a clinical trial” (Cox, Juranek and Bedi, 2019). Patients with the best GOS outcome (good response) and worst outcomes (negative or dead) comprise approximately 55% of all TBI patients, and this percentage did not differ between groups (Cox, Juranek and Bedi, 2019). 

To show the Glasgow Outcome Scale for TBIs

TBI Categorizations

Similarly, disabilities arising from TBIs are classified into four broad categories: 

  1. Decreased level of consciousness (LOC): can refer to a wide range of clinical states, such as coma, vegetative state, akinetic mutism, and locked-in states;
  2. Neuropsychiatric: mood disorders, post-traumatic stress disorder, ad personality changes;
  3. Neurocognitive: frequently involve impaired attention, memory, and executive functioning;
  4. Neurobehavioral sequelae:  irritability, hyperexcitability, nervousness, disinhibition, poor impulse controls, restlessness, and aggression by itself and with agitation, which is seen in 30% of brain-injured patients (Talsky et al., 2011).

Difficulties in Clinical Trial Categorization

All of this simply illustrates that a treatment will not positively influence most TBI patients because of the dichotomized GOS scale and the generalized/broad classification categories (Cox, Juranek, and Bedi, 2019). Effective clinical trials require measuring clinically meaningful variables in the preclinical models (rodent models) or vice versa (Cox, Juranek, and Bedi, 2019). Clinical trials for TBIs have historically shown promising effects in preclinical studies and phase I/II trials, but most failed in phase III clinical trials (Ng and Lee, 2019). Subsequently, designing and enrolling patients in an effective clinical trial will be incredibly difficult to approach (Cox, Juranek, and Bedi, 2019). TBIs are heterogeneous – no TBI is the same. Confounders, or variables that can change the association between TBIs and TBI recovery, are extensive. Confounders such as shock, medications, posttraumatic seizure, pre-injury level functions, and others can significantly affect individual TBI outcomes, making it challenging to develop clinical trials for TBI patients (Cox, Juranek, and Bedi, 2019).

To show a TBI clinical trial

Considerations for Clinical Trials

Researchers have proposed five solutions to the lack of clinical trials for TBIs:

  1. Developing a “miracle” treatment that produces an immense effect across the spectrum of injury and helps address the problem of power analysis, or having a large enough sample size that there is higher a probability of seeing a significant effect;
  2. Developing a restorative treatment with an extended therapeutic window makes the patient’s prognosis and/or risk more clear. This ensures that those who have not recovered with a standard treatment are enrolled;
  3. Developing a classification system that more rapidly identifies and strategies patients at the time of clinical presentation/assessment;
  4. Designing clinical trials that enroll every patient but later sort patients blindly;
  5. Using a different primary outcome measure based on the therapy’s mechanism of action or a particular biochemical interaction in our bodies where the drug produces its ideal pharmacological effect (Cox, Juranek, and Bedi, 2019; Salters-Pedneault, 2020).

How Power of Patients Can Help

Power of Patients stands up to present a helpful technology to improve brain injury clinical research trajectory going forward. Our Patient-Reported Outcome tracker (PRO-POP™) allows TBI patients and caregivers to track their symptoms and triggers longitudinally and in real-time. This method collects daily symptoms, producing more meaningful trends than how clinical trials gather data months apart. PRO-POP™ can allow patients to visualize patterns in symptoms unique to them, offering an in-depth characterization of the TBI population’s struggles.

To show the Power of Patients tracker created for TBI survivors

“Through our proprietary analytical process, we can build the customer dashboard and visualizations expecting to have five significant impacts in clinical trial processes:

  • Reduce incomplete patient enrollment by having pre-qualified, engaged subjects
  • Lessen long and delayed clinical trial timelines
  • Reduce clinical trial rescues by reducing screen failures.
  • Increase clinical trial success rates

  • Decreasing time to market

By doing this, TBI patients can advocate for themselves, and clinicians can use this information to provide them with pharmacological, nonpharmacological, and clinical trials to get them the help they deserve (Talsky et al., 2011).

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