Because delays or lags in the time it takes a clinical investigational site to activate a clinical trial can have a direct impact on the provision of state-of-the-art care to patients, University of Texas Southwestern (UTSW) Medical Center, a National Cancer Institute (NCI)-designated cancer center, led an investigation into the clinical trials activation process at the institution. After identifying 66 steps with 12 decision points to active one clinical trial, the team was able to streamline and simplify what is planned to be a more streamlined and accelerated process.
Clinical Trial Activation Time of Paramount Interest
Accelerating clinical trials in major academic medical centers is of paramount interest. These incredibly important institutions drive important clinical research; however, they are known to struggle with bureaucracy, politicized culture, and incoherent silos that, all together, slow down the clinical trials activation process. This hurts research and can take a direct toll on patients. For example, in oncology trials, where very sick cancer patients—potentially terminally ill—participate in new Phase I experimental medicines. Here at TrialSite News, we know of multiple cases just in the past few years where experimental, cutting-edge cancer drugs have actually slowed down a cancer patient’s disease—in some cases, even stopping it totally. So, with each day’s delay, in some cases, a patent’s life may be at stake.
Then there is the cost factor. Among industry sponsors, it is widely known that they often prefer small, privately held clinical investigational sites rather than academic medical centers. Why? Cost, speed, and an expedited way of doing business often is associated with the smaller sites over the major centers.
Led by UTSW, this particular study in Dallas, Texas, included a multidisciplinary team of stakeholders within the cancer center, university and affiliate hospitals (Children’s Health and Parkland Health and Hospital System, Dallas) that conducted a retreat to map out the actual processes involved with activating a clinical trial there. The team employed not only classical quality improvement but also Six Sigma methodology to identify and verify bottlenecks and non-value-added time in activating a clinical trial. During this study, the team identified not only the time to pass through each step but also perceived barriers and bottlenecks. The results were published in JCO Oncology Practice.
The team identified the time when the study packet containing the final clinical trial protocol, consent forms, investigator’s brochure, contract and budget was received at the study site as the starting point of clinical trial activation. They identified the time when the first patient was actually enrolled into the study as the actual endpoint of the clinical trial activation phase.
In employing Six Sigma and classical quality concepts during a retreat, the UTSW-led team identified 66 steps with 12 decision points to activate a new clinical trial. First and foremost, two steps were instituted first: 1) allow parallel scientific committee and institutional review board (IRB) review, and 2) allow the clinical research coordination committee to review protocols independent of ITB and scientific committee approval. This group involved with determining university interest and feasibility could act to review new trials in parallel. Moreover, they continue to have the clinical research coordination committee to track actual clinical trial activation time. The group used this framework (the first two changes mentioned above) as a means to identify additional steps for improvement.
The UTSW-led study highlights the power of applying quality management and Six Sigma principles, inspired by leadership directive, to identify and modify processes to improve clinical trial activation times. Importantly, the UTSW leadership, management, and key team members took a “look in the mirror” in the first place—this first step can be difficult in large institutions.
With a rapid rise in not only the actual volume of clinical trials, but also increase in trial complexity (e.g. new advanced treatments), research centers employing continuous improvement principles must become more flexible, agile, and directed. Patients can directly benefit—especially those in dire situations requiring an immediate need for medical attention. But the academic medical center benefits as well. Commercial drug sponsors seek such institutions for more study contracts.
Now UTSW can showcase that they in fact have made the organizational and process adjustments to accelerate clinical trial activation time. Key performance indicators (KPIs) should be employed by the UTSW clinical research coordination committee—the team that actually measures whether the continuous improvement program is effective—as a means of assessing ongoing actual impact.
Other research centers can learn from this study. Note that this action by UTSW reflects a trend evidencing the major academic centers responding to calls to become more agile and directed. Major academic medical centers, foundations of clinical research for not only America but the world, are gearing up for change in their clinical research operations.
Erin Williams, MBA, UT Southwestern Harold C. Simmons Comprehensive Cancer Center
Timothy J. Brown, MD, PhD, UT Southwestern Medical Center
Patrice Griffith, MBA, UT Southwestern Medical Center
Asal Rahimi, MD, UT Southwestern Harold C. Simmons Comprehensive Cancer Center
Rhonda Oilepo, MS, UT Southwestern Medical Center
Hans Hammers, MD, PhD, UT Southwestern Medical Center
Theodore W. Laetsch, MD, UT Southwestern Harold C. Simmons Comprehensive Cancer Center
Penny Currykosky, BS, UT Southwestern, Harold C. Simmons Comprehensive Cancer Center
Susan Partridge, RN, MBA, Parkland Health and Hospital System
Muhammad S. Beg, MD, UT Southwestern, Harold C. Simmons Comprehensive Cancer Center
Call to Action. Others can learn from this team’s research. Consider contacting them.