Conducting a clinical trial requires a sponsor, which is a person, institution, company, or organization (such as a contract research organization) that takes responsibility for initiating, managing, or funding the trial.
Good Clinical Practice(GCP) standards must be followed to ensure the protection of trial participants and the credibility of the results. Sponsors may outsource certain tasks to Contract Research Organizations (CROs) that specialize in services that are too expensive or time-consuming to be done internally. The Food and Drug Administration (FDA) evaluates whether private investigators are adequately supervised and if CROs are properly managed.
The European Medicines Agency (EMA) plays a key role in developing the EU as a competitive center for clinical trials and maintaining IT systems for coordination. The Clinical Trials Information System (CTIS) supports interactions between sponsors and regulatory authorities throughout the life cycle of a clinical trial. The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to further develop the EU as a competitive center for innovative clinical research. The Clinical Trials Coordination Group (CTCG) oversees the EU Decentralized Clinical Trials project (EU DCT project), which seeks to facilitate participation in clinical trials by offering maximum flexibility and convenience. Sponsors must publish the results of clinical trials within 12 months for adults and six months for children. The Clinical Trials Regulation will come into effect on January 31, 2025, and all ongoing trials approved under the Clinical Trials Directive will be subject to it.
By following GCP standards for clinical research, sponsors can ensure quality data is collected and facilitate the analysis and publication process. In addition to government oversight, sponsors and investigators can benefit from support provided by CROs after the completion of a clinical trial. This support may include assistance with data analysis, preparation of manuscripts for publication, and guidance on regulatory requirements. CROs can also provide advice on how to maximize the impact of results through effective communication strategies. Overall, CROs can provide valuable support to sponsors and investigators after the completion of a clinical trial. By following GCP standards and taking advantage of CRO services, sponsors can ensure that their clinical trials are conducted safely and ethically while also maximizing their impact.