By Paul Nicolaus

August 9, 2016 | TransCelerate BioPharma has introduced two new solutions through its Site Qualification and Training (SQT) Initiative, both supporting the nonprofit’s mission of simplifying and accelerating the research and development of new therapies by collaborating across the global biopharmaceutical R&D community.

First, TransCelerate plans to create 11 informational programs to provide less-experienced principal investigators, sub-investigators, site managers, and study and regulatory coordinators with educational content at the beginning and during the handling of a clinical research study.

“Clinical trial sponsors are required to select investigators who are qualified by training and experience to conduct clinical studies,” explained Katarina Hugeneck, SQT Initiative leader and manager of global study training at Eli Lilly and Company. “The level of experience does vary among investigators and their staff, which is why a basic clinical trial awareness program might be needed at the start of a clinical study.”

The training modules focus on the basic concepts of clinical research and can be used as a refresher, remediation, or onboarding tool in addition to the information that is already provided to site personnel by the sponsor.

“When the TransCelerate SQT Initiative created the program, we identified broad topics that were essential to cover such as responsibilities around adverse event reporting and informed consent, overview of activities for IRB/IECs, and tips for monitoring and auditing,” Hugeneck added.

Ranging in length from 20 to 40 minutes each, all of the learning modules share the same navigation features, and at the conclusion of each topic the content can be downloaded, including answers to the review questions. In addition to the 11 informational programs, SQT has also developed another short program focusing on investigator oversight responsibilities. All are accessible on the TransCelerate website.

The informational program was developed using the collective expertise of TransCelerate Member Company personnel and created in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6). The Society for Clinical Research Sites (SCRS) Site Advocacy Group also made contributions.

Streamlined Training

TransCelerate’s SQT Initiative has also implemented a new online framework to mutually recognize electronic data capture (EDC) system training taken by investigator site personnel in order to streamline redundant efforts carried out during clinical trials.

The International Council for Harmonisation’s Good Clinical Practice (ICH GCP) guidelines stipulate that all users of an EDC system are trained in the use of that system, explained Adam Colley, SQT team leader for the EDC system training framework and director of global data management at Merck & Co.

The training is generally provided by a third party such as the system vendor or the sponsor and is usually taken at the beginning of a study or a trial. It is often a prerequisite for actually accessing the system, and the permissions or capabilities that the user will have are based on his or her role.

When the TransCelerate SQT team established its priorities using input from investigators and site staff, the topic of repetitive training requirements was one of the key issues that really stood out, Colley said.

Basic, non-protocol-specific EDC training for each user involved with a clinical study at the site can last upwards of two or three hours, he continued, and for multiple users—a primary investigator, a sub-investigator and study coordinators—that amounts to tens of hours of training just for one site. If a site is participating in multiple clinical trials, the amount of time devoted to training quickly adds up.

“The real crux of it is when you take a look at the industry, many of these different sponsors are using the same EDC systems, so the sites are faced with doing this training in the same system over and over and over,” Colley said, “and that’s really where we identified that this mutual recognition program could significantly reduce that time and have a marked improvement in the efficiency for those sites.”

The program does not remove the obligation to ensure that all users are trained in the use of the EDC system, Colley explained. But it does create a platform that allows training providers to share details of the content and concepts covered in the education and guidance they provide. 

The success of this mutual recognition program relies on three key elements, he said. First, providers must share the details of the content used in the training they deliver. These are high-level concepts—not trade secrets, he pointed out.

Second, users must receive proof of completion, such as a certificate, that shows they have completed the training and provides important details such as the name of the training and the specific system and version.

This allows the sponsor, when initiating a study, to cross-reference a list of trainings on the TransCelerate website and validate key concepts provided by that training, to ensure it is sufficient for the users considering the role they will be playing in the new study.

Third, sponsors must develop an internal process that allows them to grant credits or waivers for those users based on the proof of completion of previous training, so that they do not have to go through it time and again.

“The beauty of this initiative and this program is that it hasn’t really created any new technology, and it’s not reliant on any sort of new technology,” Colley said. “It is a platform that is already available.”

In fact, the new online framework went live in June, and a number of member companies and EDC vendors have already shared the details of the training they provide on the EDC System Training Mutual Recognition web page on the TransCelerate website.

The more training providers, sponsors, and EDC vendors that come together to participate in this program, Colley said, the more successful it will likely be.

“If some are about to be trained or have just been trained, certainly I would encourage them to go to their sponsor company and ask that their training be recognized by other sponsors in the future,” Colley said, “and hopefully through that avenue… we will continue to increase our participation.”

Day-to-Day Difference

The EDC effort builds off the success of TransCelerate’s mutual recognition of Good Clinical Practice (GCP) training program—which TransCelerate CEO Dalvir Gill indicated has been one of TransCelerate’s biggest victories to date.

“Today, over 140,000 certificates for GCP training have been issued by the TransCelerate member companies,” he noted. “That means that 140,000 individuals won’t retake GCP training for three years because it’s going to be mutually recognized by the 18 companies.”

Beyond the numbers alone, there’s plenty of anecdotal support for the impact it has made. “When we go to SCOPE or we go to DIA or we go to ACRP or SCRS summits, there is incredibly strong feedback from the investigator sites themselves telling us that what we’re doing here is making a real day-to-day difference for them,” he added.

Since the organization’s inception in 2012, TransCelerate has worked to reach its target outcomes by tackling the various frustrations expressed by investigators. Along the way, it has been crucial to gather feedback from stakeholders in order to make progress.

“If we are going to work with investigator sites, it was important that we engage investigative sites,” Gill said. “Often we have a perception of what the sites feel their burden is, but the sites are actively involved in delineating what that burden might be and helping with the solution.”

“We know that our typical day-to-day business practices within clinical trials, clinical research, and pharmaceutical trials in particular have a pretty substantial burden that is outlaid onto the investigator sites,” he continued. “We wanted to streamline and make more efficient the connections and touchpoints between sponsors and sites, particularly at the beginning of a study.”

In doing so, it enables the sites to focus on aspects that are far more important, he added, including the patients participating in those clinical trials.

Gaining Momentum

Although in some cases the work carried out by TransCelerate may seem obvious, these issues just weren’t being addressed in the past. It took a forum like TransCelerate, according to Gill, to take a disciplined approach to identifying a problem, bringing its membership together, soliciting input from stakeholders, and following a carefully planned roadmap in order to deliver those very pragmatic, tangible outputs.

The founding member companies of TransCelerate are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since inception include Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc., Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. and UCB. 

None of this work is easy because all the companies are unique, Gill pointed out, and each one has different risk aversions, different training groups, and different quality assurance groups. But now that there’s been some successes and recognition that the wheel need not be constantly reinvented, a sense of momentum has picked up.

The member companies have come to recognize and even embrace the notion that they can find ways to work collaboratively on ideas without impacting their competitive market positions. “There is no benefit to doing something like EDC training or GCP training or other informational components… at the company level,” Gill said. “Yes, you may have some nuances you want to apply, but if you really look at it and you really dissect this problem, there’s no good reason to do it differently.”

The premise behind TransCelerate’s efforts is that a rising tide lifts all boats. “It’s not an individual company. It’s multiple companies, and these 18 companies at TransCelerate are a very substantial part of the clinical trials around the globe,” he said. “So when they decide we’re going to adopt similar templates and forms and recognitions for training, it has an immediate downstream impact for the investigator site.”

“We haven’t invented anything massive here,” he acknowledged. “All we’ve done is brought consistency to the process.” But projects like the GCP and qualification and training projects have been instrumental in bringing that trust and collaborative spirit together, he noted, so that even larger problems and challenges can be addressed and overcome moving forward.