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Although there are thousands of pharmaceutical companies involved in the global production of various pharmaceuticals, most of them are not fully aware of the CDISC requirements. Most pharmaceutical companies are trying to meet the deadlines of their contract manufacturing activities and may not be in a position to meet the new CDISC standards on time. This has resulted in a delay in the release of new commercial products and the upgrading of clinical data management software. CDISC standards are a very important component of the international regulatory bodies and are an essential part of the clinical trial process. However, pharmaceutical companies must be extremely careful not to violate any of the CDISC standards and ethics in order to protect the integrity of the clinical trials.

What Are CDISC Standards?

The Clinical Data Exchange Standards Consortium is a non-profit standards-developing organization involved in aligning medical research data with patient care, to facilitate information exchange and improve healthcare. The consortium has come a long way since its inception but to date, there are no regulations governing its activities. It has come under fire from several members, not because they have any concern about the quality of the organization’s work but because they are not allowed to vote on the standards or hold a vote in the governance group. The current governance group however is composed of senior scientists and executives from prominent academic and pharmaceutical institutions.

The Clinical Data Interchange (CDISC) standards are a global set of quality improvement programs and practices, developed by the Organization for Quality Improvement (O QI) to upgrade the data exchange used in clinical practice. The CDISC program was established in response to the U.S. Information Quality Service (US iQIS) clinical standards program. US iQIS is the national criteria for quality improvement in all aspects of health care. CDISC is an international collaboration of stakeholders from health care, information science, and engineering who are committed to improving clinical practice, data management, and outcomes.

One of the main concerns that some groups have regarding Clinical Data Interchange is the cost that will be involved in its implementation. These groups claim that the standards body will arbitrarily award fees to doctors who will participate in the consortium without any regard as to whether they are capable of implementing the guidelines. They claim that the process should be controlled to ensure that only doctors can make the submission. However, the consortium insists that the criteria for eligibility to join the consortium will include the country the doctor practices as well as the competence and experience of the doctor in carrying out clinical research. The criteria for eligibility also includes scientific expertise in matters relating to the field concerned.

Another concern is the future of the clinical research process, which is part of the CDISC guidelines. Some people argue that the whole idea of the guidelines is to control the clinical trials in order to reduce drug development costs. If the drugs are developed on an expensive R&D platform and if the drugs cannot be used in clinical trials due to their adverse effects, then what is the point? Hence, the use of CDISC is necessary to ensure that clinical research is conducted in a planned manner. If the data quality is not maintained, then we may be facing another set of problems like drug re-designing and the emergence of a black market where counterfeit drugs are sold off.

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Final Words

The Clinical Data Interchange (CDISC) Standards have become a major tool in the information systems field. The CDISC standards program ensures that health care institutions and professionals have up-to-date and reliable mapping and sharing of all patient information, including diagnosis, treatments, and procedures as well as mortality and morbidity data. The mapping and sharing of these critical data must be accurate, complete, and up-to-date at all times because failure to comply with CDISC standards can result in the immediate cancellation or suspension of a facility’s clinical data management software.