In the decades since DSMB’s were first established, their makeup and structure may have changed, but their mission has stayed the same: To protect the safety of patients, ensure the integrity of data and determine treatment efficacy in clinical trials. To do this, DSMBs must create an important sense of trust during the drugs and treatment development process -- a sense of trust that will ripple out to stakeholders in every direction.
What was once a team of experts operating behind the scenes has been thrust into the spotlight during the pandemic. Indeed, DSMBs today not only need to perform their duties, but they need to do them in an unbiased, consistent and documented way that will hold up to public scrutiny. So, how can clinical trial oversight teams create that magical sense of trust in a study and its outcomes that translates numbers and research into something everyone can put their faith in?
Today, DSMBs and other expert clinical trial oversight teams can go above and beyond in their work to create magic by leveraging smarter software and the advantages and opportunities it can offer.
1. LEVERAGE NEW STRATEGIC COMMUNICATION NORMS AND EXPECTATIONS TO BUILD NEW STANDARDS FOR EXCELLENCE & TRUST
When a DSMB is equipped with state of the art cloud software for communication and data management, their work can go from “keeping up” with the pace of the study to driving greater speed and safety and process transparency to their important work. DSMBs so levered with smart technology can set new standards for excellence and trust. Smart software allows DSMB members to securely communicate between meetings, making sure that everyone is updated along the way and that people are ready to make decisions faster.
This means the DSMB members and ad hoc support can begin the study knowing that they will all be asynchronously available to each other throughout the study, not just during scheduled meetings. By setting the expectation of strategic conversations between meetings, the continuity of the study oversight can be supported.
2. ENGAGE AD HOC SPECIALISTS TO SUPPORT AND STRENGTHEN OVERSIGHT WITH ASYNCHRONOUS WORK IN REAL-TIME
In addition to the “1) One or more experts in the clinical aspects of the disease/patient population being studied, 2) One or more biostatisticians, and 3) Investigators with expertise in current clinical trials conduct and methodology” that the NIH specifies every DSMB must include, the NIH also states that ad hoc specialists can be brought in to advise at any time. Whenever possible, this is an excellent option, and one of the major obstacles has always been geography.
The pandemic has forced us all to work differently, and with the normalization of remote work, so too are we seeing an opportunity to normalize and leverage ad hoc specialists for DSMBs. Oversight teams who want to bring in ad hoc specialists to support and strengthen their oversight can use smarter software to offer secure access to study data and secure communication with the rest of the team. A single, integrated, cloud-based platform supports virtual and asynchronous work in real-time.
3. DEEPEN AND SUPPORT APPROPRIATE EXCHANGE BETWEEN CRO/SPONSOR AND DSMB
Smart software, platform architecture, as well as role-based permissions, can facilitate and protect communications for faster, safer clinical trials. Because every DSMB is part of a study that has a CRO and/or a sponsor, there will need to be communication between the DSMB and these organizing entities. But those communications also need to be highly regulated to protect data and independence. All participants must have direct, easy access to what they need, when they need it, but must be blocked from what they should not see.
At the same time, smarter software can offer the opportunity to make communication and updates more frequent and effective from the DSMB to the CRO/Sponsor. Because study data and communication will live in a central, secure location that needs less upkeep, this opens up opportunities for the DSMB to communicate in new and supportive ways. Indeed, when the work of the DSMB for clinical trial oversight gets easier, everyone’s work gets easier -- and that is great for patients and drug development.
Smart software allows for faster thinking at a time when we need it most. At a time where we are all still adjusting to post-pandemic norms it gives teams a chance to adapt to these new normals. But most of all, the forward-thinking teams that embrace smart software for their work can create the much-needed trust in the process and the invaluable treatment fruits of their efforts. This is the real magic. Can your trial oversight team create it?
Click here to access our essential guide to the future of clinical trial oversight