The rising cost of clinical research is leading more sponsors to outsource research and development (R&D) to clinical research organizations (CROs) to achieve efficiencies of scale that many companies can’t on their own. According to a 2016 Contract Pharma outsourcing survey 73 percent of industry professionals reported an increased demand for outsourcing. To achieve efficient, effective clinical trials that enable drugs and devices to reach the market as quickly as possible, sponsors and CROs need to develop ways to optimize their relationships.
This is especially crucial for emerging or small and mid-sized biopharma companies (SMB) operating with lower R&D budgets and smaller staff (approximately a dozen or so employees). We will discuss what SMBs should look for in a CRO, and how such companies can best utilize their services.
Small Biopharma Companies Utilize CROs Differently than Big Pharma
Large pharmaceutical sponsors primarily use outsourcing partners as tacticians who can reliably execute their clinical trials. However, an emerging biotech may rely on a CRO for much more. While a large sponsor selects outsourcing partners after an investigational new drug (IND) filing, SMBs can often benefit from involving a CRO much earlier in the process or even as part of the IND submission process. If this is the SMB’s first IND filing, a CRO can aid in determining what it needs to get an IND approved, as well as help a sponsor select the right vendors to run their trial efficiently from the start.
Finding the Right CRO Partner
Since an SMB sponsor will want to involve a CRO at the earliest stages of clinical trial design, it’s critical that the CRO fit in well with the sponsor’s culture and that it devotes a dedicated and flexible team, including a single point of escalation, to the sponsor’s project.
SMB sponsors should seek a partner that is prepared to work with senior executives on a personal level in a more dedicated fashion that perhaps would be found when working with a large pharma company. CROs can be valuable in speaking directly with chief executives to develop a trial that serves the investigational new drug’s regulatory, economic, and therapeutic characteristics. This includes being able to speak the science fluently. Communicating and setting expectations about what’s needed for drug development is important, but even more critical is communicating what’s happening therapeutically within drug development.
Continuity is key. Large pharmaceutical companies employ their own regulatory teams to handle IND submissions, whereas small startups don’t. Using a small full-service CRO to assist in filing an IND and maintaining the same project managers throughout development will ensure continuity.
If a CRO is involved in a trial from the initial IND filing, it’s advisable for both parties to agree on their clinical endpoints prior to the start of the trial. In addition, they’ll need to mutually decide what data to collect along the way to achieve those endpoints. To maximize this effort, a SMB sponsor should look for a full service CRO that can assist with not only filing an IND, but determining key performance indicators such as cost per enrolled subject, trial retention and on-time database lock to measure the trial’s success. SMB sponsors may want to consult their outsourcing partner more frequently while designing their protocols to ensure they’re setting themselves up to meet performance goals.
Keys to a Successful Partnership
A CRO can help a small sponsor submit their IND, develop a clinical trial strategy and execute a successful trial. To be effective in carrying out these duties at the outset, the sponsor should be transparent with its outsourcing partner, make sure everyone is on the same page and clearly delineate each party’s responsibilities.
A sponsor should also communicate who the key stakeholders are. Once stakeholders are identified, the best method of communication vehicle is established (email vs phone call) and depth of the communication and governance (comprehensive details vs. high-level, need-to-know information) is agreed upon, ongoing communication is essential. A CRO can help the company determine and prepare what information they need to present to the board and investors, highlighting the need for regular updates to the CRO including the progression through the development process and board and investor meeting schedule among other things.
Effective communication at all levels is fundamental to developing teams that work together to get research done. When communication flows easily between the sponsor and contractor, all stakeholders will have reasonable expectations for each step of the clinical trial process.
When an SMB engages a CRO, the strategic goals and success of the trial become their shared responsibility; they become one team. Accordingly, an SMB sponsor will derive the most benefit from a CRO that specializes in SMBs, like Novella Clinical. These CROs understand the unique dynamics of an SMB company, and can provide more personalized attention, making for good teamwork, and the best possible outcome for these clinical trials.