By | 2018-09-12
Pharmaceutical Clinical Data Management

Clinical Data Management(CDM) and CDISC standards: Many pharmaceutical and biotechnology companies are working on the development of new drugs, compounds and devices for betterment of human health and increase the quality of life globally. This process of drug development and discovery when reaches the stage of testing in human volunteers involves people from various specialty and varied background. Final goal of any human trial is to be able to investigate the safety and efficacy of the investigative compound or device in human subjects within the regulatory guidelines and accepted standards of safety, patient care and data interpretation. The initial stage of any clinical study involves the collection of observational, laboratory and other data of the trail subjects and is the most critical part in the study life cycle. It is this collected data, which will be used in analyzes of final end points of any study. The quality of data and accuracy then becomes most important thing. The greater the un ambiguity of collected data the faster will be the analyses of the study objectives. The role of CDM becomes very critical in this aspect. Coming to modern time the paper CRF’s became the de-facto mode of collecting the observational data for any clinical trial. This collected data then reaches the CDM department. The main role of CDM is to verify the accuracy of the data and correct any ambiguity in it. This process would involve many back and forth communication with the concerned investigative sites until 100% data is reported clean. Now we have many good CDM systems which gather the source data from these paper CRF’s. But in spite of having these systems there is still a gap in global standardization in data naming conventions and a wide array of different forms and formats are being used to collect clinical trial information into these CDMS systems. Many organizations have developed their own processes and procedures. This has resulted in data being collected and submitted to regulatory bodies in various formats and which in turn made the whole process of clinical study life cycle less streamlined and resulted in delays in many of the components of drug discovery and clinical trial process. In order to create a global standard in how the data should be collected and submitted to regulatory bodies, the CDISC then took the initiative to bring consensus on the standardization of not only in the submission data but also, in the very source of data collection into clinical trial management systems (CDMS). First step in this direction was to come up with the standards and format in which the final data to be submitted to regulatory authorities. SDTM, ODM were the first steps from CDSIC in this direction. CDISC has worked with the FDA to assist in the development of a complete electronic medical research process. In 2006 the FDA adopted the CDISC SDTM for electronic submissions as cited in the Electronic Common Technical Document (eCTD). The second scenario involves only the submission of data to regulatory bodies in SDTM format. The last one would involve only the CDMS data collection in SDTM standard. The advent of EDC systems has not only made easier to capture data remotely from various sites but also with inbuilt validation and edit checks it has made possible to collect error free data in the very first stage. All this has helped in reducing the total time in getting 100% clean data, the data analyzes and reporting and final submission to the regulatory agencies. Today we have many different types of electronic data Capture solutions and may different vendors. Although these solutions have made the data capture and analysis accurate and easy to great extent, But if we look into another side, it has also resulted in so many variations in the data collection modules, namely the electronic case report forms (eCRF’s). There are now hundreds of variations in the CRF design that basically capture the same information. Equally there are thousands of different naming conventions of the data filed on these eCRF’s and mapping to the internal database. Moreover, these EDC systems could be integrated with other data capture systems like IVRS and eDiary, which in turn have their own data formats and naming convention. To eliminate this ambiguity the CDISC has come up with the new initiative named CDASH. The goal of this initiative is to describe recommended basic standards for the collection of CTD in EDC trials. CDASH moves upstream in the data-flow and identifies a basic set of highly recommended and recommended/conditional data collection fields that are expected to be present on the majority of CRFs. Following quote from Good CDM Practices summarizes the need for it: “There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial, with the exception of the protocol, which specifies the conduct of that trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.” With the new standards being defined, it becomes a challenging task to the CDM departments of the trial sponsors or a CRO to change, metamorphose and evolve with these standards. Especially from CRO perspective this would involve not only the right EDC and data management tools to conduct and manage the trials but also work with sponsors in helping them to develop and conduct the EDC trials as per these standards. Of course, these CDSIC standards will be evolving further and go through many version changes as new scenarios come up. In the end one common standard will result in streamlining the drug development and clinical trial process across the globe and eventually the complete harmonization and effortless streamlining of Medical research.