Adaptive Platform Trials

Adaptive Platform Trials

Adaptive Platform Trial for PTSD - Cohen Veterans Bioscience

The Challenge:

ZERO: The number of diagnostic tests and treatments for Post-Traumatic Stress Disorder approved by the FDA in the past 17 years.

Our military warfighters and veterans and all people with PTSD deserve better.

People with PTSD can experience very different physical and emotional symptoms. Certain types of psychotherapies are recommended by the Veterans Affairs and Department of Defense PTSD Treatment Guidelines, but they are often not preferred by or accessible to the majority of those suffering with PTSD. There are only two FDA-approved medications for the treatment of PTSD. Likewise, these medications do not work well for a lot of people, particularly when the presentation of PTSD is complex as is often the case in active-duty and veteran military service members.

There are few potential new treatments currently in development and several of those already tried in patients with PTSD have failed.  The VA’s 2017 Consensus Statement of the PTSD Psychopharmacology Working Group and other sources confirm that there is a deficient pipeline of new PTSD medications. The clinical, social, and financial burden of ineffectively treated PTSD is enormous.

We need to find better ways to select and test new treatments.

The challenge is that not all forms of PTSD are the same – we need biomarkers to subtype individuals (as we currently do in different forms of heart disease and cancer) – to individualize therapy.

To select better candidate therapies to test – we need better targets based on an understanding of biological pathways and circuits – so we can develop precision therapeutics.

With this combination, clinicians would be able to recommend a specific treatment for a person with a specific subtype of PTSD, a practice known as personalized or precision medicine.

Our Goal:

Build a new precision medicine pipeline by:

  1. Establishing a national network of centers that incorporate innovative and streamlined design approaches to test multiple therapeutics in parallel under highly rigorous and standardized methods.
  2. Identifying a pipeline of candidate therapeutics to test based on available evidence.
  3. Accelerating the validation of biomarkers for subtypes of PTSD.
  4. Creating a learning system where data from these studies is used to foster a better understanding of biological mechanisms that cause PTSD to find the next generation of targets and biomarkers.
  5. Advancing successful treatments and biomarkers to the next stage of development and ultimately to the clinic.
Our Flagship Program:

CVB is spearheading the design of one such innovative clinical trial, an adaptive platform trial (APT). This APT aims to identify effective PTSD treatments and PTSD biomarkers through an award from the U.S. Army Medical Research and Materiel Command (MRMC). As the Clinical Coordinating Center, CVB will build, manage and oversee all the operations needed to design and conduct the study.

In a Team Science approach, CVB’s internal experts are gathering input from scientific, clinical, and drug development experts from industry and academia to refine the design of the APT.  In addition, this study design has the benefit of additional input from experts from Department of Defense’s PTSD Integrated Product Team,  the Veterans Health Administration (VA), National Institute of Mental Health, National Institute of Alcohol Abuse and Alcoholism, Food and Drug Administration (FDA), and Defense Health Agency’s Psychological Health Center of Excellence.

The information learned in this clinical trial will be used to advance treatments into the next steps required for FDA approval and inform Clinical Practice Guidelines for the treatment of PTSD.

Cohen Veterans Bioscience and Parexel Biotech Collaborate on Landmark Adaptive Platform Trial Studying Posttraumatic Stress Disorder (PTSD) Pharmacotherapeutics

November 11, 2019
Cohen Veterans Bioscience announced its strategic collaboration with Parexel Biotech, a new division of Parexel, for an adaptive platform trial evaluating pharmacotherapeutics to treat PTSD. Learn More

What is an Adaptive Platform Trial? Why is it more efficient than a traditionally designed clinical trial?

Traditionally designed clinical trials that usually test one medication at a time are generally time-consuming and expensive and have been associated with high failure rates.

Adaptive platform trials (APTs) are a newer alternative to traditionally designed clinical trials. APTs allow researchers to test multiple treatments for a medical condition at the same time. By testing these treatments at the same time and in the same way, information can be borrowed from one treatment to the next resulting in fewer patients needed to volunteer for the study. In addition, as treatments complete testing, new treatments can be added to the platform for testing so there is less time spent in closing down a trial and starting up the next one, saving valuable time and money.

APTs also serve as a learning system in which researchers can use data collected from an ongoing trial to make fast, smart, and timely adaptations to that trial that can improve its efficiency and shorten the time to achieve trial results.

 

How are biomarkers used in an APT to improve treatment effectiveness?

Biomarkers can be used to confirm a diagnosis, identify subtypes of a medical condition, and predict response to treatment. In an APT, biomarkers may be used to assign patients with that biomarker to specific test treatments that are predicted to target that PTSD subtype. In PTSD where there are no confirmed biomarkers, an APT can generate evidence to discover and confirm biomarkers. Once confirmed, the APT can use these biomarkers to support a precision medicine approach for PTSD and with enough evidence support the biomarkers use into everyday medical practice.


The PTSD Adaptive Platform Trial:

CVB is the Clinical Coordinating Center for the design and implementation of an adaptive platform trial (APT) that aims to identify effective PTSD treatments and PTSD biomarkers through an award from the Department of Defense’s U.S. Army Medical Research and Materiel Command (MRMC).

The PTSD APT will enroll military service members (active and veteran) from 18 to 65 years of age who have a current diagnosis of PTSD and are found to be eligible to participate in the trial through a screening process. The trauma leading to the development of PTSD could have occurred any time before, during, or after the participant’s military service.

Parexel Biotech has been selected as the trial’s primary Contract Research Organization and will partner with CVB to provide clinical trial implementation services over the multi-year study.

CVB and Parexel Biotech will identify and work together with leading academic, private, VA, and military clinical research centers that will enroll eligible participants and conduct the study according to an established protocol.

The study is projected to begin enrolling patients in 2020.

Sign up for email updates to receive the latest developments about this Adaptive Platform Trial for PTSD.

 

“As the only nonprofit organization focusing solely on PTSD and TBI research, Cohen Veterans Bioscience is leading critical efforts to develop treatments for these serious brain disorders. MTEC is honored to support their mission to improve the brain health of our veterans and the broader civilian population,”
Lester Martinez, MD, MPH, Major General (Retired), U.S. Army, President and Chairman of MTEC Board