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The CRO Forum has been asked by TransCelerate to collaborate on reviewing its initiatives. Alan Metz, Forum Chair, and Amy Kissam, Forum Vice-Chair, sit down with Moe Alsumidaie to elaborate on the CRO’s involvement.
TransCelerate has been around for nearly four years, and is making advancements in collaborative efforts between biopharmaceutical enterprises aimed to reduce drug development costs. The latest news comes from the CRO Forum, which has been asked by TransCelerate to collaborate on reviewing its initiatives. We had the opportunity to interview Alan Metz, Senior Vice President at Quintiles, who serves as Forum Chair, and Amy Kissam, Executive Director of Global Operations Management at INC Research, who serves as Forum Vice-Chair.
Moe Alsumidaie: Can you describe the structure of the CRO Forum?
Alan Metz: All the members of ACRO are represented on the Forum and all CROs have the opportunity to nominate a representative to participate in the Forum whether they are ACRO members or not. Currently 11 CROs are involved including Quintiles, INC Research, Bioclinica, Parexel, Chiltern, PPD, Covance, PRA Health Sciences, ICON, Premier Research and inVentiv Health. For non-ACRO member companies, the cost to join the Forum is only $10,000. We have a monthly teleconference and a quarterly face-to-face meeting which Amy and I lead. Our agenda is largely focused on the (TransCelerate) work streams that we are participating in. TransCelerate’s lifecycle of thinking involves reviewing and refreshing their strategy going forward and they have asked us to comment and contribute to that refresh.
The CRO Forum establishes its own working groups with subject matter experts from Forum member companies. For each of those TransCelerate work streams, there is a parallel Forum work group of our subject matter experts, and a liaison to maintain the relationship between TransCelerate and CRO Forum stakeholders.
Moe: How many workstreams is the CRO Forum currently involved with?
Alan: TransCelerate had 14 work streams when we got involved. We initially agreed to participate in four of those based on the principle of what the nature of those work streams were and if we could meaningfully contribute. The four included risk-based monitoring, quality management systems, site qualification and training and common protocol template. As the relationship has expanded over the past year, additional work streams have been created. We have agreed to participate in two of them: the shared investigator platform and eConsent.
We have ramped back our involvement in site qualification and training because it was our assessment that the work stream had reached the point where it had completed the design and creation process and was beginning to implement it. It is important to make the point that we see ourselves as contributing to the design and creation of processes around particular initiatives rather than officially endorsing or implementing them.
Moe:Can you elaborate on your involvement with, and perspectives on the competitive nature of the initiatives?
Alan: The best example is the shared investigator platform. There is a lot of appeal to create a common, single investigator site portal because that theoretically makes it much easier at the site and investigator level to conduct clinical studies. However, a number of pharma companies already have their own unique site portal and even though they're involved in the work stream creating a common portal, they won’t necessarily adopt that, because they feel that there is an opportunity to customize what they need for their own company. Similarly, in the CRO industry, individual companies have portals which they believe are competitive and have their own intellectual property. So there is a transparent understanding that this collaboration will create tools such as the common portal for companies that do not yet have one, but will not necessarily be used by all companies.
Moe:What is the importance of incorporating the CRO perspective into TransCelerate’s initiatives? Why do you want to be involved in TransCelerate’s initiatives?
Alan: The outsourcing rate has increased dramatically in the industry over the past 20 years as many pharma companies are seizing the opportunity to not carry a large overhead of resourcing. CROs are able to manage that overhead by conducting what we call ‘labor arbitrage’–in essence, moving resources from one program to another as needs change. Whereas when a pharma company is getting out of a particular disease area, or its product fails, they have the challenge of dealing with an overhead they’ve built, and resources that they now have to offload.
With outsourcing increasing rapidly, the CRO industry has developed expertise in a multiplicity of different domains. A lot of what the pharma companies have been dealing with is maximizing the opportunity to utilize that expertise and looking for efficiencies in those spaces.
It is a very competitive marketplace, and now is evolving very rapidly to address cost control. As TransCelerate goes down the pathway of cost control and seeking operational efficiencies, they are appreciating that the content, skills and expertise sits within CROs. Accordingly, TransCelerate is asking the CRO Forum to contribute their expertise and experience to assist them in describing and defining opportunities for cost control and operational efficiency
For example, risk-based monitoring, a lead initiative pushed by the FDA, was embraced conceptually by the pharma industry but its actual implementation and optimization sits with CROs because we do all the monitoring. It is a very exciting and competitive time as CROS describe their individual and optimized RBM programs – the TransCelerate work stream desires to bring all those learnings together.
Amy Kissam: CROs can provide a unique perspective within certain TransCelerate initiatives because we work with numerous sponsors across multiple therapeutic areas and many of them within the same indication. We are able to gain or ascertain a greater insight: into development and operational efficiencies, potential risks, or areas of opportunity that might not be identified from a single trial or protocol.
In addition, we bring a wealth of knowledge about trial execution and delivery that is essential for success and as Alan has already indicated, the industry is under cost pressures and cost controls. RBM is a great example of an initiative that has evolved over many years to develop data driven methodologies using technology to effectively leverage resources. Success with implementing these types of initiatives is through well-structured change management plans, of which CROs have the extensive experience on successful implementation models.
Moe: What is in plan for future initiatives between TransCelerate and the CRO Forum?
Alan: The shared investigator platform, which includes the site portal, and eConsent initiatives; eConsent is an interesting one. Intuitively, it makes a lot of sense to say we need to simplify the informed consent process because at the moment it is very cumbersome and challenging for patients, largely–to be frank–around complexities brought to the table by legal departments, seeking to protect their companies. One would like to think that consents should be appropriately informative, and that you would not have 20-page forms which nobody really reads thoroughly or fully understands, and so there is an opportunity for simplifying that process. It is possible that making consent forms digital, and with a more common language, would catalyze the process of simplifying them and making them more meaningful to patients.
One of the major sources of delays in getting studies up and running is the customization of the informed consent for each particular site or academic institution, which require their own modifications of the informed consent. There are opportunities for everyone ranging from the sponsor all the way through to the patient to improve this process.
Moe: What perspectives do CROs have that pharma companies don’t when collaborating on these initiatives?
Alan: We are the ones who are on the ground at the site; having discussions with investigators and helping them submit documents to their ethics committees. We are the people who experience trial execution, in every single country with every single site and hospital authority around the world.
Amy: We also have a better understanding of the patient’s perspective, for example, the consenting process. Our monitors are at the sites obtaining feedback from the study coordinators about the challenges within the informed consent process, such consent is too long or difficult to understand. The more we understand the challenges and burdens of our sites and patients and ensure it is addressed into our clinical development processes, the faster we can bring drugs to market.
Moe: How has the TransCelerate pharma collaboration evolved over the years?
Alan: If we step back and think about it, credit is due to TransCelerate for taking on these initiatives. Pharma is a highly competitive industry and companies are challenged to work with each other but, through TransCelerate, they have found a way to collaborate. They are about four years into it, and there is a tremendous amount of learning that they've achieved through collaboration.
Some work streams have been found to be not very productive. That’s a learning in and of itself. The plan to refresh the TransCelerate strategy will allow companies to report what is working and what isn’t, and uncover new opportunities and areas for improvement. We all know the metrics around rising drug development costs; TransCelerate’s collaborative platform to improve efficiencies in drug development is a very positive and massively important advancement that will hasten the pace at which drugs get to market. We all have that as a common interest.