Just one in ten drug candidates are successful in clinical trials, and the number of products making it from development to approval is currently at an all-time low.
It means sponsors must seize every opportunity to beat the odds – and partnering with the contract research organization (CRO) with the skills and expertise to get their new products across the line is one such opportunity.
With a thorough understanding of, and a wealth of experience in drug development, CROs are used to navigating the processes’ pathways and obstacles, meaning they know how to design and execute studies that get drugs approved.
Specialized CROs can act as a clinical partner throughout the development process, working side-by-side with sponsors to establish goals and timelines, and with a mutual understanding that makes them an extension of the companies they work with.
But choosing the right CRO for your organization’s needs isn’t always a straightforward process. While companies may be tempted to outsource the whole process to one of the “top ten”, these larger organizations are rarely the best fit for biotech’s needs.
Industry research has shown that pharma and biotech companies are unwilling to commit to the inflexible contracts larger CROs often insist upon, and high staff turnover rates can detract from the collaborative culture many sponsors are looking for.
Larger CROs can have an “all encompassing” structure which, while promising a single-source remedy, often exposes a lack of focus and innovation in an area that may be critical for a particular study. What’s more, the importance of cultural fit should never be overlooked, as it facilitates the efficient communication needed to drive study delivery.
So, what should companies look for when selecting a CRO clinical partner? And how can they be sure their product will receive the rigorous, compliant testing it both needs and deserves? Here are our top considerations.
Balance of Benefits
Managing a clinical trial entails a multitude of complex elements, from study design, randomization and trial supply management (RTSM), data management and data collection, to systems, biostatistics, pharmacovigilance, regulatory compliance, and medical writing.
The big names in the CRO sector may offer all of these services combined with their clinical operations core support, they are not always geared towards the smaller client, or the more specialized expertise required to carry out all these tasks in specific indications or more complicated trials.
A general rule of thumb in outsourcing is to partner with providers that would derive between 1% and 5% of their revenue from your custom project – and this holds true in the pharmaceutical sector.
The CRO services market will be worth an estimated $56.34 billion by 2023, with the prominent players – IQVIA, LabCorp, Parexel, PRA, PPD, ICON, Syneos, Charles River, Wuxi and SGS – accounting for more than 50% of that figure.
At between $3 million and $5 million, then, the average cost of a biotech company’s single Phase I clinical trial represents on average less than 0.002% of a large CRO annual revenues. It means the “big 10” will prefer to gravitate towards the larger and more profitable pharma studies. There is a high risk that a biotech's trial will not get the attention it requires and that it will be prioritized after larger sponsors’ requests. When a larger sponsor’s trial is in difficulty, for example, there is a tendency to reassign smaller trials’ resources to it with the consequence that the smaller sponsor’s trials will suffer delays or quality issues.
Biotech companies could benefit from looking further afield for better suited organizations.
Evaluating Expertise
Well-designed clinical trials are critical to the successful development of drugs, biomarkers, and devices. Companies need a partner that will work with them to carefully plan the course of their clinical trial, proactively improve predictability, reduce risks, and help them reach go/no-go decisions faster.
The first step to choosing an appropriate CRO is speaking to as many of them as possible about how they would organize your study.
It’s usually fair to say, for example, that a company that provides high-quality design consultancy has expertise in the closely linked areas of data management and biostats. Ultimately, a full-service organization may be able to meet high-level needs overall, yet it might not have specific expertise across all areas. A more focused organization, on the other hand, will have limited its expertise to a specialism, and dedicated all of its resources to providing quality in that area.
Trials can fail for all manner of reasons, from inadequate study design, improper dose selection and non-optimal assessment schedules, to inappropriate metrics/markers, issues with how the data are analyzed.
Study design, then, is critical to success.
Sponsors and CROs should discuss:
- What type of study is needed (parallel, crossover etc.)?
- What are the optimal study objectives to consider?
- Whether an adaptive design is necessary?
- What type of randomization is needed (permitted blocks, minimization etc.)?
- How the trial population is calculated.
- Etc.
The questions are numerous, and only experienced scientists will be able to answer all of them simultaneously to produce a design that will minimize the chance of trial failure.
Sponsors need to be confident that their chosen clinical partner is competent enough to respond to, as well as anticipate and be prepared for, requests from regulatory authorities.
Cultural Fit
The right cultural fit, or the compatibility and consistency of people and mission, is crucial to collaborative working. It means teamwork, trust, transparency and recurring business opportunities. And it works both ways – cultural fit must be reciprocal.
Some companies are open-minded, while others are closed to new ideas, new processes, and disturbances to their daily routine. But designing a new molecule requires innovation.
Sponsors should consider if their trial resonates with the CRO’s mission and values, whether the company is science- and customer service-driven, as well as more practical considerations such as geographical location.
Experience
Typically, sponsors use CROs because their own expertise does not extend to managing or submitting studies to regulatory authorities for review.
Requesting consultancy services is a great way to assess the experience and expertise of a CRO – but that’s not limited to therapeutic experience.
The sponsor specializes in creating new drugs, requiring experience and expertise in technology appraisals. An effective clinical partner also needs to understand how to design, set up, conduct, close and submit a robust clinical trial.
Biotech companies should also look at how many trials the CRO has been involved in, which therapy areas they have worked in, their presence in the scientific literature, and their connections with regulatory authorities.
Consistency
Returning customer and turnover rates are good ways to measure consistency.
Often, big CROs fail this aspect due to high turnover rates. This can disrupt trials, as finding, training and on boarding new resources can translate into delays. Consistency can also be jeopardized if processes to bring new team members up to speed are lacking.
Flexibility and Scalability
Strategic forecasting, proactive communications and governance meetings are usually used to gauge flexibility and scalability.
During the trial, there will be times when resourcing will need to be adjusted in one direction or another. The current COVID-19 crisis is a good example of where some trials may be put on hold when other needs take precedence.
Sponsors should consider whether their CRO partner of choice is capable of, and has experience in, reassigning resources from one trial to another.
Value Specialization
Each individual aspect of clinical trial management requires a different skillset. It means that one-stop shop CROs are not always the best solution, and biotech companies will be best served by selecting the “best in breed” in each category.
Many biotech companies agree that design, biostatistics and data management, such as case report form (CRF) and RTSM processes, should be outsourced to the same organization as they are so closely linked. CRF design, however, should be reviewed by a statistician to ensure all edit checks are in place and that data collection is coherent with the Statistical Analysis Plan (SAP).
Clinical monitoring can be outsourced to the CROs which have the necessary resources in the selected countries, and regulatory aspects need to be carried out by organizations that have proven expertise in this area.
All of this should be coordinated by a project manager who can maintain control of the program at sponsor level. Biotech’s seeking to outsource this element tend to choose the CRO they have used to provide biostatistics and data management or the clinical monitoring.
Road to Success
Choosing CRO partners can be a headache, but by following a few simple principles, biotech companies can ensure the road to phase I success is as smooth as possible.
The value of services should represent between 1 and 10% of the vendor’s annual revenues – the higher the proportion, the more attention the trial will attract.
What’s more, specialized CROs offer high-quality services, flexibility and can respond quickly to client needs. They are laser focused on their area or areas of expertise, and do not view their services as ancillary to the activities of larger, more expensive revenue generating groups.
When choosing a CRO partner, reputation, and level of experience and quality of services are key considerations.
Author Biography
Serge Bodart has worked in the Pharmaceutical Industry for 20 years. He co-founded SYMFO, a European-based electronic Patient Reported Outcome (ePRO) provider where he has been involved in all aspects of the electronic Clinical Outcome Assessments (eCOA) life cycle from concept to commercialization. As an internationally recognized thought-leader, he acted as the eCOA Subject Matter Expert and Scientific advisor for companies such as Biomedical Systems, Bracket Global and Signant Health. In his career, he also gained extensive International expertise in business development. He currently serves as Chief Commercial Officer at IDDI, an eClinical and Biostatistics services CRO based in Raleigh, NC and in Belgium. Prior to his Pharmaceutical Industry career, he served as a Major and helicopter pilot for over 20 years in the Air Component of the Belgian Army. He is based in Montreal, Canada and holds a master’s degree of Science in Telecommunications from the Polytechnic Division of the Royal Military Academy in Brussels, Belgium.
For more information please visit: www.iddi.com or email: [email protected]