It is essential that the highest quality forms of communication are used between investigators and sponsors at all stages of a clinical trial. This article describes how quality can be maintained and improved using a virtual interactive (VI) methodology when conducting online web meetings with your investigators to promote high conformance with protocols and good clinical practice.
CATEGORIES: Good Clinical Practice, Virtual Interactive Methodology, Virtual Investigator Meetings.
The quality of the communication between sponsoring pharmaceutical client and their clinical trial investigators is of paramount importance in the efficient management of any clinical study. Furthermore the sponsor is responsible for the provision of all study related information to the investigator who then relays this to the local site team. As stated in the ICH guidelines for Good Clinical Practice (GCP): 4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions. 5.23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs. This information exchange is traditionally conducted during investigator meetings and there is a need to bring investigators together both at the outset and at key points during a study. Typically the sponsor will want to gauge any anticipated or potential problems in executing the study protocol or patient recruitment issues ahead of a face to face investigator meeting. The investigators are then brought together to learn about the background to the study, preclinical and clinical data, review of the study protocol, AE/SAE reporting, GCP, eCRF completion etc. At further points there will be a need to reconvene this group and address another ICH guideline: 5.23.5 Communication between investigators is facilitated. This is a key point as many important issues and experiences can be discussed and best practice shared amongst the investigator community to enable appropriate modifications to be made, but only after some experience has been gained and therefore missing the main face-to-face meeting opportunity and further face-to-face meetings are prohibitively expensive.
So what are the alternatives to face-to-face? Simple teleconferences – but these are often ineffective. Or perhaps the dreaded ‘WebEx’ meeting where an unwilling group at best passively watch some slides go past for a couple of tedious hours. So this leads the question, just how effective are these? Sponsors report very poor engagement of sites during WebEx virtual meetings and this is not surprising. The format is so didactic, there is little engagement with the participants who may withdraw from the meeting at any point and typically lacking any motivational dimension.
One of the fundamental principles of any effective meeting is to actively engage the audience and WebEx struggles with that basic requirement. However now that new technologies are available this can be addressed. The advent of virtual interactive (Vi) investigator meetings means that investigators can share ideas in an interactive fashion. The process of doing this forces 100% active participation and, coupled with a skilled virtual moderator the investigators are encouraged to engage and discuss key issues. If a programme of varied interactions is designed, the site teams become motivated, interested and maintain concentration for the full duration. Furthermore there is another advantage. Very often only the principle investigator (PI) might travel to a face to face investigator meeting however using the VI approach the PI can assemble the whole team to receive the sponsor’s information or training first hand. Virtual interactive investigator meetings can radically improve training, recruitment and motivation of sites in a multi-centre study.
There has never been a better time to fully engage your investigators using virtual meetings and the advent of virtual interactive (VI) techniques has made this a real alternative to further face-to-face events without the engagement and quality compromises of a didactic online slide-show.