How GCP COMPASS relates to the current scenario ?

GCP COMPASS has access to 2000+ years’ worth of collective practical GCP implementation experience through its thought leadership of senior advisors, advisors & experts. With ongoing COVID-19 crisis and the challenges the regulatory & bio-pharmaceutical/ health care organisations are facing because of it; extraordinary measures are being put in place to manage ongoing studies, protect patient safety and data integrity.

The regulatory agencies recognise impact of the COVID-19 pandemic on the conduct of clinical trials. Various challenges exist which result in restrictions of visits to healthcare facilities, increased demands on the health service and changes to trial staff availability. Trial participants may also be required to self-isolate, which would further make it difficult for investigators to maintain their medical oversight. These challenges could have an impact on the conduct of trials, such as the completion of trial assessments, completion of trial visits and the provision of Investigational Products.

The impact of COVID-19 on ongoing trials, on opening new trial sites in an existing trial, on ongoing recruitment and continued involvement of participants in the trial, or on starting of new trials also need practical consideration & some innovative approaches e.g. remote/ risk-based monitoring, risk-based quality control. It is also important to consider national recommendations and measures including travel restrictions and confinements of trial participants and trial staff and the availability of trial staff to perform visits, enter data in the Case Report Form (CRF), notify serious adverse events and, more generally, follow the protocol. In all this, the ability to confirm eligibility of study patients and to conduct key safety assessments and trial evaluations is of paramount importance.

Any proposed actions should be proportionate and based on benefit-risk considerations, on contingency provisions taken nationally and locally by the authorities, with priority given to the impact on the health and safety of the trial participant. Where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine, may be required to identify adverse events and ensure continuous medical care and oversight. However, the limitations and risks of such methods and the requirements for data protection should be considered and such alternative arrangements need to be adequately documented.

These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. Regulatory agencies recognize that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. Although the necessity for, and impact of, COVID-19 control measures on trials will vary depending on many factors, including the nature of disease under study, the trial design, and in what region(s) the study is being conducted, some regulatory agencies have outlined the general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity and it is extremely important these are understood and implemented in a way not to compromise patient safety, data integrity and local requirements including any data protection/ privacy regulations.