In partnerships, effective communication is an important element of success. And in the clinical research community, patients suffer when communication fails. This is why it’s so important that sponsors, CROs and trial site staff maintain open, honest and streamlined communication.
In this post, we explore what can go wrong when communication breaks down and some of the tools and best practices clinical research stakeholders can use to prevent this from happening.
When miscommunication surrounding clinical trial sites happens, results can be severe. Indeed, the startup process can be hamstrung because sponsors and sites are left guessing as to the site’s performance based on the needs of the trial and the teams involved, says Shree Kalluri, founder and CEO of Forte Research. This stems, in part, from the common difficulty of incorrect enrollment numbers and the need to base decisions on estimates.
When communication between both parties fails, resources are wasted and the trial is set for poor performance.
Healthcare and science journalist Alaric DeArment gives the example of an endocrinologist in New Orleans who was working on a clinical trial. Despite repeated efforts to contact the CRO, she and her team could not get a copy of a protocol amendment. They were faced with a changed trial design but had no idea of how the change was to be implemented. The endocrinologist ended up having to contact the sponsor’s medical science liaison as a last resort.
The endocrinologist told DeArment that the incident was not an isolated example but rather a pervasive issue among CROs. The result is a sponsor and CRO unable to communicate effectively.
CROs have faster trial startup times compared with biotech and pharma companies because they have invested more in technology. The solutions that shorten startup times include “clinical trial data management systems and commercially available databases and market intelligence on investigators and sites,” writes Mary Jo Lamberti, associate director and research assistant professor at Tufts Center for the Study of Drug Development.
Part of the drive behind this technology adoption is that CROs are increasingly taking on more trial operations and, consequently, regard technological solutions as key means to streamline their processes.
Indeed, using technology to improve communication and the flow of information among CROs, sponsors and trial sites is essential to better trial management. Creating a collaborative ethos enabled by technology means silos can be broken down and data can be shared more effectively and easily.
Better data flow between sites and CROs speeds up trial startup times, Lamberti explains, and this is even faster when trial sites are used repeatedly rather than sourcing new sites.
A good example of working to improve communication comes from non-profit organization TransCelerate BioPharma, which has partnered with 19 biopharma companies for better clinical trial operations, says Lamberti. Using tech-powered tools such as a shared investigator, cross-industry platform, administrative time for sites and sponsors can be reduced and startup processes streamlined.
It takes 15 years on average to develop and approve a new drug and this comes with a price tag of some $2.5 billion. Inadequate processes and communication only adds to the time lag and financial burden, with missed milestones costing about $1 million a day, write Dr. Jack Gilbert and John Slattery.
Rather worryingly, 50 percent of trial sites choose paper-based trials in a bid to save money. However, the reality is delays of 30 percent and inflated costs of 60 percent. Further technology problems stem from an average of 10 different software applications being used in a study, which results in staff turnover and added stress for sites, sponsors and CROs, the researchers explain.
What is required, then, is an interoperable and integrated digital health ecosystem, Gilbert and Slattery argue, that focuses on six dimensions of the patient: “their ‘omics’ data, EMR data, patient-generated data, their behaviours and motivations, their microbiome, their exposome and social determinants of health.”
However, this ecosystem isn’t just better for study results from streamlined information about patients. It can also help sponsors and CROs gain a better understanding of the trial through remote and individualised patient monitoring. It is also a boon for communication between the relevant parties, Gilbert and Slattery say, as the focus is on patient-centricity, which leads to more proactive engagement from all stakeholders.
When it comes to relationships with CROs and sponsors, most trial sites want improved communication and streamlined processes. They want realistic expectations from their partners and the ability to communicate these desires, explains Jim Kremidas, executive director at the Association of Clinical Research Professionals. But they also want support throughout the study, which requires clear lines of communication from beginning to end.
The industry is adopting more automated processes and this is especially useful for the flow of information. CROs, sponsors and site staff have plenty of technology at their disposal, but information sharing remains a challenge, says Jim Reilly, vice president of clinical strategy at Veeva Systems.
The much-needed shift underway, then, is bringing technology and processes together to automate the exchange of information, Reilly adds. The obvious solution is a unified clinical operating model, which 87 percent of clinical operations professionals have stated they aim to do. A unified model based in the cloud that automates the exchange of information will break down some of the persistent communication barriers between CROs, sponsors and site staff, he writes.
Reilly expands on the idea of a unified operating model in an article published by the Drug Information Association. He says it will break down silos separating sponsors and CROs. Using function-specific eClinical applications, stakeholders will have a holistic view of the trial, including internal and external processes, along with more direct communication.
Quality management analytics have become an important component of clinical trials, and regulatory agencies are driving this. The FDA announced that it will implement risk-based inspections using technological tools to assess high-risk sites, writes Moe Alsumidaie, head of research at integrated research organization CliniBiz.
The above developments should be looked at within the bigger picture of quality tolerance limits as set out in the ICH E6 R2 guideline.
A necessary consequence of quality compliance is that pharma companies need to be more vigilant when selecting a CRO partner and any other third-party vendor. The importance of streamlined communication between site staff, sponsors and CROs then takes on more importance than ease of trial operations but goes to the very heart of compliance. If communication breaks down with vendors, sponsors could be on the wrong side of regulations.
Following a similar thread of vendor oversight, Kristy Galante, director of external alliances at Janssen, explains that part of the problem lies with sponsors not dedicating sufficient time to define oversight. The result is often misaligned definitions between CROs and sponsors, which leads to many challenges, including failed communication.
To ensure clarity of communication in trial matters such definitions and timeframes of deliverables, metrics and output, Galante says data is key. Having data to objectively measure risk and performance means the need for subjective feedback is lessened. Data-driven approaches result in improved vendor oversight but also increased consistency and communication.
Technological tools don’t need to be expensive or designed specifically for a trial. CROs, sponsors and site staff can all improve communication by existing tech tools, writes head of clinical operations and research strategy at consultancy GeoSera, John Carlos Diaz.
He notes, however, that many clinical researchers don’t make use of the tools currently available to improve communication — and this is true of small and large pharma companies and CROs, operating in the US and elsewhere. Free communication services such as Skype and WhatsApp allow video conferencing and instant messaging, both powerful tools for trial staff. They allow more immediate communication, and reduce the number of emails sent to already cluttered inboxes.
A caveat here is that IM should be used for non-essential issues rather than essential decisions, which should be kept in email, Diaz adds. While there may be criticisms that such an approach to communication would disrupt the important issues of quality assurance, compliance and audit trails, Diaz says these are unfounded if communication of non-essential items remain the focus of these tools.
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