Clinical trial sponsors struggling to keep track of study drugs need to abandon their paper-based systems and fast-forward into the electronic age, argues clinical technology organisation ClinPhone.
Good manufacturing, clinical and distribution practices in major markets such as the US and the European Union call for drug accountability, reconciliation, returns and destruction (ARRD) procedures in all clinical trials, so that investigators can ensure the relevant products are used only for patients enrolled in an approved protocol.
In effect, that means knowing at all times the exact status and location of every investigational drug unit throughout the study life-cycle and supply chain, from the manufacturing plant to the trial site and the returns depot to the destruction facility for unused medicines. Any discrepancies run the risk of being exposed in regulatory audits, with possible sanctions to follow, ClinPhone notes.
With most clinical sponsors still relying heavily on manual, paper-based systems, the demands of ARRD can be labour-intensive and time-consuming. Information is collated from a variety of sources and in a variety of formats, such as e-mails, paper forms, e-mails and electronic shipment files, ClinPhone points out. This results in frequent duplication and poor transparency, increasing the potential for errors and confounding efforts to achieve full documentation of the ‘chain of custody’ for individual units of medication.
In a recent opinion poll of trial participants, 28% of respondents told ClinPhone the biggest problem they faced in managing the drug accountability process was ensuring the provision of appropriate documentation to meet regulatory requirements. Another 26% highlighted difficulties in consolidating site records, depot records and destruction certification.
Drug accountability has lagged behind other related clinical trial activities in migrating to e-solutions, comments ClinPhone. The UK-based company offers a Drug Accountability package that enables study leaders, site/monitoring personnel and distribution depots to input, access, verify and integrate data at all stages of the trial programme.