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Michael Christel is Pharmaceutical Executive and Applied Clinical Trials' Managing Editor. He can be reached at email@example.com.
The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.
The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals. What is less readily apparent, however, is what approaches in this area have worked successfully and which ones have not in recent years, as biopharmaceutical sponsors deal with a changing drug development environment, one influenced by such factors as regulatory pressures, rising R&D costs, growing healthcare spending, and the challenge of rushing trials of experimental drugs and vaccines for outbreaks such as the Ebola virus.
During a panel discussion at Partnerships in Clinical Trials, leaders from four industry organizations spoke about the strategies and solutions their companies have attempted in efforts to accelerate study execution. Among the areas highlighted were process and technology initiatives related to patient recruitment, site engagement and activation, lab testing, and direct-to-patient care.
Published reports find that 86% of clinical trials experience delays, and according to CenterWatch, 81% of these reach one to six months in length, with 5% of delays lasting even longer. Session moderator Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing at Nektar Therapeutics, pointed out that there are myriad issues that occur in the life of a clinical trial that can set timelines back very quickly. He referenced the analogy of drug developers “building the airplane while 30,000 feet in the air.” He noted that if sponsors and CROs don’t reach the key milestones in a trial upfront, they are unlikely to make up ground the rest of the way. The ability to meet those milestones hinges greatly on execution, communication, and the expertise of the clinical team.
In efforts to speed up clinical trials, Charles Drucker, Director of Client Facing Operations and Alliance Management for Quest Diagnostics, acknowledged the benefits of new technologies, but said it is process improvements that may be the biggest difference-makers. He cited historical examples in the medical field, such as the Apgar scale in assessing a newborn baby’s health, and the decision following the Iraq and Afghanistan wars to move mobile army surgical hospitals significantly closer to those wounded and hurt. In the drug development setting, Drucker discussed how process improvement strategies have led to new approaches in patient convenience. Those include designing protocols that allow for mobile phlebotomist visits to patients’ homes or the option for patients to visit storefront laboratories to draw blood instead of making repeated trips to the investigative site. Another example of process improvement referenced by Drucker is designing trials with just one investigative site, where the site leverages patient service centers for blood collection and performs all its outreach and recruitment through social media. Qualified patients are given an all-expense-paid trip to the trial site. There, the patient learns how to give him or herself an injection, how to take a picture of the injection site with a phone, and the process of setting up visits with the study nurse. Subsequent blood draws are administered at a storefront lab near the patient’s home, and the remainder of the trial is conducted by phone, Skype, and through patient-reported outcomes (PROs) and surveys.
Manny Lazaro, Head of Clinical Operations at Forum Pharmaceuticals, pointed to the advantages of mobile units for patient retention, particularly in developing countries where subjects more commonly live in remote areas. He noted, however, that setting up these units can be expensive, and it’s important for sponsors to build the costs into their budget during the planning stage. The speakers noted as well that not all therapeutic areas are conducive to a mobile-trial approach.
Another solution brought up the by panel to help speed up studies is expanding the level of site engagement. From a sponsor perspective, Lazaro stressed that it’s critical to not lose site of investigator relationships. To that end, establishing a field-based force of medical directors that make sure the investigators understand the science and the safety profile of the product candidate is important. Investigators need to be invested in the clinical trial process, not just handed a protocol to serve as a third-party vendor, in essence, Lazaro said. Other components of increased site engagement include site visits, booster visits, focus groups, and “rejuvenation meetings,” where sites and sponsors/CROs can get together to discuss any problems and each site can leave with an action plan in place. The speakers indicated that such avenues as leveraging local medical science liaisons and key opinion leaders and having a sponsor’s medical director tour sites has resulted in an upsurge in patient recruitment for their trials.
Terri Roberson, Senior Director, Humira and Immunology, Clinical Program Development at AbbVie, noted that while the industry has yet to find the smoking gun to truly speed up clinical trials, developing innovative and aggressive strategies in study start-up have paid dividends. She discussed her company’s recent experiment in site activation, where it was able to set up 40 sites in 40 days for a global trial that already included 80 existing sites. She attributed the results to several factors, including starting out with a mass outreach effort for investigators, empowering clinical research associates and monitors, conducting all the feasibility assessments by phone, issuing no-negotiated contracts, using ePRO devices, requiring that sites have a central institutional review board (IRB), qualifying each site during one visit, and providing a 24/7 hotline for the sites. Roberson said the 40 sites activated in the pilot program ended up enrolling patients 100% faster than the existing trial sites had.