A Full-Service Clinical Research Organization

Apr 05 2017

Gene Therapy 2.0

Perspectives from the Medical Writing Team

 Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

MIT Technology Review (March/April 2017) lists “Gene Therapy 2.0” as one of the 10 Breakthrough Technologies of 2016.  I was intrigued to see this technology listed as “breakthrough” in 2016, since it had been studied for decades.  The results of this therapeutic approach were mostly negative, marked in particular by the death of 18-year-old Jesse Gelsinger in a clinical trial in 1999.  Recent developments, however, have brought gene therapy to the forefront of combating life-threatening disorders, including rare diseases.  Because of my specific interest in rare disorders and the special challenges they pose in drug development, this re-emergence of gene therapy as an effective tool is particularly exciting. Continue reading “Gene Therapy 2.0”

Apr 03 2017

Reflections on Rare Disease Day 2017

LuAnn Sabounjian, Head of Clinical Operations & Drug Safety, PROMETRIKA, LLC

On a cold, clear Tuesday morning, the State of Massachusetts commemorated the 10th anniversary of Rare Disease Day, which takes place annually all over the world on February 28th, with a celebration at the State House. I was lucky enough to be in the audience that day to hear compelling policy debate, heart-wrenching stories of struggle, and an inspiring call to action that all focused on one thing… research. Continue reading “Reflections on Rare Disease Day 2017”

Mar 29 2017

Perspectives from the Medical Writing Team

“The Cancer Lottery”

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

“The Cancer Lottery” in MIT Technology Review (January/February 2017) provides an excellent overview of precision medicine in treating cancer by following the journey of an artist living with cancer for over 30 years.  I find the linear approach, where we can hone in on a specific root cause of an event on an individual basis and then go “fix” it, very appealing; and hence, I was looking forward to learning more about precision medicine in a real world setting.

Developing drugs that target key specific mutations in diseases offers a simple and intuitive treatment approach.  The caveat, however, lies in taking a simplistic view of intricate disease mechanisms.  Despite demonstrating promising results in oncology, as evidenced by the blockbuster drugs Herceptin, Gleevec, and Zelboraf, precision medicine has mostly been ineffective due to the complexity of diseases. Continue reading “Perspectives from the Medical Writing Team”

Mar 27 2017

Focus on Personalized Attention and Customized Reporting

Stacy Surensky, CPC, Director CDM, PROMETRIKA, LLC

Executive Summary

A small biopharmaceutical company with big aspirations and unlimited potential was not getting the personalized attention that they expected and deserved from their large CRO. Instead, their needs often took a backseat to the needs of larger organizations, which, in some cases, led to frustrating delays.

When the CRO did focus on their studies, it was unable or unwilling to accommodate requests for things like customized reports and specialized processes. In PROMETRIKA, they found a CRO that shared its views on collaboration, and served more as an engaged partner than a disinterested service provider. Continue reading “Focus on Personalized Attention and Customized Reporting”

Oct 25 2016

Are Digital Health Technologies Worth It? A Frank Assessment.

Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC.

Without question digital health technologies are revolutionizing clinical development and execution. From electronic patient reported outcome (ePRO) systems to wearable devices, they can, when used properly, provide many benefits, including:

  • Accelerated trial timelines
  • Increased data accuracy
  • A patient-centric approach to data collection
  • Improved treatment adherence
  • Increased ability to study rare diseases

Continue reading “Are Digital Health Technologies Worth It? A Frank Assessment.”

Jul 22 2016

The Continuing Evolution of the Clinical Data Manager Role

Stacy Surensky, CPC, Director CDM, PROMETRIKA, LLC

Last year in our blog post titled “The New Clinical Data Manager,” we wrote about some key changes to the clinical data manager role that have taken place in recent years. What is fascinating to me is the pace at which the versatile position continues to evolve. Having worked on both the sponsor side and the CRO side in various Clinical Development roles, I have never seen this role change as rapidly as it is changing today.  To stay ahead of the curve there are five critical areas of growth that I believe all data managers need to be aware of:

  1. The acceleration of clinical trials due to new technology

Continue reading “The Continuing Evolution of the Clinical Data Manager Role”

Sep 16 2015

The New Clinical Data Manager

Cortney Greenhalge, CDM, PROMETRIKA, LLC

The role and skill set of a Clinical Data Manager (CDM) is constantly changing as technology and processes advance. CDMs have evolved into data management leaders, possessing skills in areas such as database building and programming, project management, and budget maintenance, on top of the standard collection, cleaning, and management of subject data in compliance with regulatory standards. With the addition of new regulations and electronic data capture (EDC) systems, more and more data managers are “wearing multiple hats.” The need for well-rounded, informed, and cross-functional CDMs is on the rise. How do we ensure that we, as CDMs, keep pace with the significant technologic advances that have occurred within clinical research over the last 10 to 15 years? Continue reading “The New Clinical Data Manager”

Aug 19 2015

Risk-Based Monitoring

by Kara Grew, Clinical Operations Project Manager

Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data. In most cases, the risks of the trial and the data to be collected are determined prior to study and site initiation, to identify monitoring needs. In addition, a Medical Monitor or Clinical Director will often provide input into the identification of critical data points based on the therapeutic area, indication, overall protocol requirements, safety profile of the compound, device or biologic,  and the primary and secondary endpoints for evaluation. Once the plan for targeted monitoring is finalized by the study team, the Risk-based Monitoring Plan will be included as part of the overall Monitoring Plan and Clinical Research Associates (CRAs) assigned to the trial will be trained on these monitoring requirements.

Continue reading “Risk-Based Monitoring”

Jul 14 2015

Ensuring the IDMC is Independent: The Case for Outsourcing IDMC Statistical and Coordination Services

Amanda Rychel

The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data. By definition, an IDMC is an entity that operates independent of the study sponsor. To limit bias, it is important that the sponsor is able to manage the trial while an independent body makes decisions on the safety and therapeutic values of continuing the trial. Continue reading “Ensuring the IDMC is Independent: The Case for Outsourcing IDMC Statistical and Coordination Services”

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