Clinical trials are all about data. The data collected from these trials, along with the work performed by analysts, will determine whether a new drug gains FDA approval. For that reason, data managers are critical to the clinical research process. Recognizing that, the Society for Clinical Data Management (SCDM), a global non-profit organization, was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which has become a must-have resource for SCDM members managing trial data.
“In any clinical trial, information needs to be reported a certain way,” says Demetris Zambas, VP and Global Head of Data Management at Novartis, and chair of SCDM. “Standard coding exists on a global scale which allows us to normalize information and ensure it is being reported correctly. Data managers also perform checks on the data to make sure the information collected is logical. This is important since everything we do is very heavily regulated by the FDA and others.”
The primary mission of SCDM is to help advance the discipline of data management. One of the ways it does so is by offering training, either directly or through partnerships. Another way is the Good Clinical Data Management Practices guide book, which SCDM created early on to provide guidance to clinical data professionals.
According to Zambas, the best practices are thorough and cover every step of the data management process. For example, it includes information on how to review a protocol, identify what is relevant from a data collection and processing perspective, set up third-party studies, and design data capture tools.
Over the years SCDM formed small groups of subject matter experts (SMEs) who wrote the best practices contained in the guide. A rigorous process was put in place for the SMEs to first identify the best practices. Those practices were then made available for review and public comment before being finalized and included in the guide.
Why Give It Away For Free?
Clearly, a lot of work and effort was put into the guide. This may have many wondering why SCDM made the decision to make it available to nonmembers as well as association members. Zambas believes the decision was looked at from a couple of different perspectives. First, the charge of the organization is to promote quality, excellence, and better management of clinical data. As an organization, SCDM is dedicated to the development, support, and advancement of the profession. He points out that nowhere in that charge does it say, “Only for the benefit of SCDM members.”
“Making this information available to everyone could be looked at as our contribution to the data management community,” says Zambas. “We also believe that by showing the value of the work we’re doing, we might be able to add more members. At the same time, we want to work closely with regulators and have them provide feedback on what we’re doing. When regulators create new guidance, they make it available for public comment. Since our group provides comments to the regulators on what they’re doing, we want the others to be able to do the same for our guidance. By making the guidance open, more people can review it and provide feedback to us.”
Zambas adds SCDM has spent a lot of time deliberating on this decision, and keeping the guide private simply did not align with SCDM’s mandate as an organization. Members felt the most significant thing they could do for the data management community was to further develop and advance the discipline of data management. Making the guidance available was the best way to do that.
Another reason for the release was to drive better data management practices and consistency around the world. Zambas notes data management as a field is picking up significantly, especially in emerging markets. In some countries, businesses do not have the capacity to create their own internal procedures. Those companies could actually use the SCDM guidance as their own internal standard operating procedure (SOP) and not have to create one from scratch. “We are in the business of educating, advancing, and promoting the data management field,” says Zambas. “Not selling information.”
Although anyone can comment during the public comment period, only SCDM members can participate in updating or creating a new section. Participants must also be a member to be an editor, a direct contributor, or take part in a task force.