Successful treatment development relationships rely on the ability of contract research organisations to bring their skills to the table – and pharma’s willingness to let that happen
The caricature of a pharma company operating beneath an impenetrable cloak of secrecy has been fading for sometime – even inside the deafening echo chamber of the internet. In reality, industry has – particularly in the last decade – formed cooperative, galvanising and often brilliant partnerships with public health, med tech, contract research organisation (CROs) and even each other.
Indeed, if the 70-year-old NHS-pharma relationship represents a long-running soap opera, then CROs therein provide an intriguing supporting role, with the potential to sustain many positive storylines in their own right.
Within this overarching healthcare narrative, CROs enter the scene at various stages in the journey of a medicine, providing critical expertise in several areas of treatment development, including preclinical research, clinical trials, product approval and target markets. This relationship can be a long-term arrangement, with the CRO delivering a full service model, or simply a quick one-off consultation, after which the CRO exits the stage (presumably in the hope of returning on a more permanent basis during the second act).
The scale and global coverage of CROs mean they have a unique ability to support global studies run by both small biotechs – which don’t have the personnel numbers to resource the study – and those pharma giants who have wisely chosen to focus heavily on research and development innovation.
There is no doubt that in recent years CROs have played a more significant role in the wider pharmaceuticals ecosystem – bit parts have expanded and CROs are increasingly receiving top billing and international recognition.
Going to the next level
Paul Quinn is the former vice president of Vectura Group, and spent many years as a director at both Pfizer and Shire during a prolific period of treatment development in the 1990s and 2000s. He is also vice chair of the steering group for PharmaTimes International Clinical Researcher of the Year competition.
Quinn is convinced that in order to realise a slick, mutually beneficial and multi-operational CRO-pharma partnership, each link-up should be built on two-way trust and accountability, allowing the CRO to fully execute their activities to the agreed contract and project plan.
“A successful partnership will deliver synergy, by providing expertise and resources to supplement the pharma company’s in house expertise,” says Quinn. “This allows companies to focus on their core activities, while the CRO optimises the use of its considerable resources.”
Quinn’s extensive experience across pharma has established some key criteria for productive, open and effective partnerships. He advises: “Start with a clear and detailed ‘request for proposal’ and, importantly, give the CRO time to respond and provide input into the protocol before the contract is signed. The key, however, lies in following the plans, utilising governance structures effectively, regularly reviewing the state of play and being prepared to adjust.”
In recent times, Quinn has observed new ways of working, which are making the CRO role much more data-driven. Historically, the data required for CRO oversight plans has been produced on a timely basis, as defined in the original plan, but this has often been too late to shift the project focus.
“A key to changing this situation is the automation of metrics data, which allows real-time adjustment of the study, such as timely closure of non-performing sites, the addition of new sites and enhanced training to remedy errors,” he explains.
The modernising of the CRO role – and the growing influence of digital – has been crystalised by the move to ‘electronic trial master files’ (eTMF). Indeed, this represents a truly game-changing moment, according to Quinn. “Documents can be seen at a glance, allowing rapid site approval and a real-time view of CRO performance,” he reflects. “The visibility of the eTMF also means that regulators expect the TMF to be maintained in real time, not just updated in a few weeks prior to an inspection.”
Quinn sees the next decade as one of seismic shifts, with major factors, such as the advent of wearable technology, integration of electronic healthcare records, entry of data directly into clinical databases, patient driven trials and climate change causing major disruption to the pharma and CRO terrain. Combining to embrace and overcome these ‘new world’ challenges will require CROs and pharma to work more closely than ever.
The force awakens
Richard Staub is R&D solutions president at IQVIA – one of the most successful global CROs and a forerunner in modern CRO-pharma partnership methodologies. Richard has witnessed pharma’s relationships with CROs evolving, from resource capacity management and cost-efficient solutions, to custodians of intellectual property and masters of protocol design, study implementation and strategic thinking.
“With the evolution of big data in the industry, we are sitting on top of the world’s largest curated healthcare database,” explains Richard. “Today we are able to bring insight into clinical trials which, historically, industry couldn’t reach. It’s changing what those relationships look like and awakening potential.”
In Staub’s experience, the most impactful CRO-pharma collaborations have properly defined governance models, setting the tone early on and allowing CROs to operate throughout the continuum of delivery, while establishing the capability needs of each project.
Achieving the sacred CRO-pharma equilibrium isn’t easy, but IQVIA have achieved the sort of balance that has seen pharma ‘swipe right’ when choosing the company as their preferred CRO.
“A customer service mentality, in which we strive for an open and honest relationship, is built into the DNA of our organisation,” says Richard. “Drug development is something that does not always go according to plan, so open dialogue, recognising the challenges ahead and retaining the flexibility to change course at any time is essential.”
This cohesiveness and desire to achieve complete alignment with pharma clients has been one of the hallmarks of IQVIA’s success. “We are all in this for exactly the same reason,” insists Richard. “To benefit the patient through the products we bring forward. If you have the patient at the centre of everything you do, it quickly brings objectives into sharp focus.”
In terms of getting the most from a CRO-pharma partnership, Richard firmly believes there has to be a shared goal and a mutual commitment to building a high level of trust, which encourages both parties to bring ideas to the table.
“Another vital aspect is ensuring that outsourcing is strategic,” says Staub. “Some customers talk about being strategic, but then stray into tactical areas and this can lead to getting bogged down in conversations about pricing and so on. Companies should always be wary of bringing a CRO in too late or after targeted markets have already been decided.
“CROs don’t just want to become the ‘arms and legs’ of the project, we need to be at the heart of it – bringing all our knowledge and intellectual property as early as possible. With the ‘IQVIA core’ we take all our data and build advanced analytics in order to power protocol design, site selection and patient enrolment,” he adds.
As CROs adapt to the changing environment Staub is convinced that big data and technology will be play a larger role. One of the notable trends he is seeing across the marketplace is greater complexity of science and clinical trials. In the last few years he has witnessed a 15% dip in the number of patients participating in trials, while the number of procedures in clinical studies has risen by 70%. Furthermore, the inclusion/exclusion criteria have risen by over 50% and the number of countries used has risen, as studies start to target very specific patient groups.
“We are at a point where we must continue to transform clinical research,” concludes Staub. “Five years down the line, I can envisage the rapid advancement of virtual trials. We are investing heavily in this area, because at the moment only 5% of patients participate in clinical trials. Virtual trials will allow connected devices, wearables and home-based blood withdrawals, negating the need to travel, and paving the way for a futuristic development landscape.”
When they are afforded the freedom to maximise their influence, CROs represent a reassuring and robust system of examination; adding new perspectives and an often unrivalled breadth of knowledge. At their best, CRO-pharma partnerships can unlock the true potential of treatments, ensure credibility prior to entering the marketplace and above all make an enduring difference to patient lives.
It is clear that a strong and harmonious relationship between pharma and CROs is pivotal. Engendering an environment where the respective skill of both parties can flourish creates better products and triggers innovation. The most successful partnerships provide compelling evidence that ‘chemistry’ isn’t just confined to the lab, it is essential in every relationship that pharma makes.
John Pinching is an experienced healthcare commentator who has written extensively about the pharma universe and the NHS