By John Carlos Diaz, GeoSera Consulting
What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?
Sadly, the cost of a failed partnership between a pharma company and a CRO is not just a monetary loss and lost R&D time; it also could lead to a trial with a negative outcome or a complete response letter (CRL) from the FDA. Trials with negative outcomes or CRLs are crippling to companies of all sizes, but a CRL can cause people to lose jobs and can literally close the doors of a small pharma company, as a small company may not have a strong enough pipeline to keep it afloat.
How many clinical research colleagues have heard from pharma, CROs, service providers or research sites that they “want to be partners” with each other? I am going to guess that 99 to 100 percent of readers have heard this phrase in their careers. Now, more importantly, how many clinical research colleagues actually see this partnership occur during the conduct of a clinical trial? Many fewer, I am sure.
For the purposes of this article, I will ignore large pharma and large CRO partnerships, since most large pharma companies have preferred provider CROs with incredibly long contracts. Partnerships between large pharma and large CROs tend to be quite bureaucratic, with numerous KPIs, and have less focus on conducting clinical research in an efficient manner.
The following items must be approved by each department or organizational leader to create a quality partnership between pharma and CRO:
- Agree on the experience levels on both the pharma and CRO teams.
- Focus on a few KPIs that are important.
- Trust the operational staff.
- Create short- and long-term timelines and milestones.
- Establish clear roles and responsibilities.
1. Agree on the experience levels on both the pharma and CRO teams
Having the proper team in place, in my opinion, is the most important part of conducting quality clinical research. Pharma companies must take proper care when interviewing the team of the CRO that has been selected. The CRO staff should be experienced in the therapeutic area to be studied, while also having the appropriate personnel to support the trial.
When a CRO is selected, the CRO’s team’s CVs are reviewed and approved by the pharma company. Now why does the CRO not have the same opportunity to review the sponsor’s CVs? How many of my CRO colleagues have had to “teach” parts of trial oversight and conduct to a junior person at the pharma company? CROs have numerous responsibilities that they are contracted to perform in generally very tight timelines. Taking time out of their day-to-day workload to explain the basics to an inexperienced pharma team can be detrimental to meeting those goals.
2. Focus on a few KPIs that are important.
Recruitment milestones are the most important milestone to pharma. The longer recruitment takes, the longer it will take for the drug to be approved and the longer it will take for that drug to generate profit for the company. Other milestones, like site activations, query resolution rate, monitoring frequency, and monitoring report finalization, are important as well; however, each pharma company has its own set of important KPIs that the CRO can agree upon.
3. Trust the operational staff.
The operational team supports the day-to-day work of clinical trials as their full-time responsibility, without being pulled in many directions like most executives. The executive teams of both the pharma and sponsor need to trust their operational staff to perform their responsibilities with minimal executive involvement. Granted, the operational staff needs to have the right tools to conduct their responsibilities, but micromanagement from the executive team does not lead to efficient conduct of a clinical trial. If the operational team is not trusted, they feel less empowered to use their experience to make proper and proactive decisions.
4. Create short- and long-term timelines and milestones.
The outsourced model of clinical research requires numerous service providers. Effective communication across all these service providers is not always easily achievable, but one way to keep all parties focused on the same goal is to set clear short-term and long-term timelines and milestones. Short-term goals help the team powering through the day-to-day work get a sense of achievement, because some of the milestones in clinical research are a long way off, such as last patient out (LPO). This LPO date could be years after the study team begins setting up the trial. Long-term goals are needed to keep the team focused on the bigger picture.
5. Establish clear roles and responsibilities .
Setting clear roles and responsibilities are essential to avoid inefficient, duplicative efforts by both the CRO and pharma company. The contract between the two parties can serve as the backbone for defining each party’s roles and responsibilities and help avoid conflict that could arise from duplicative effort. The roles and responsibilities can be detailed in the project plan, which will serve as the document to guide operational oversight of the trial. The responsibilities must be easily accessible -- not buried in an extensive plan that is not referenced frequently by either the CRO or pharma.
Forming quality partnerships between pharma’s and CROs is essential to executing clinical trials in an efficient manner. There must be a commitment from both the sponsor company and the CRO to form a partnership. By implementing agreements on experience levels of study team staff, focusing on important KPIs, trusting the operational team staff to perform their responsibilities, creating short- and long-term milestones, and setting clear roles and responsibilities, the parties can improve their chance of achieving a successful partnership.
About The Author:
John Carlos Diaz has been in the pharmaceutical industry for 18 years, with ranging operational experiences from preclinical drug metabolism and pharmacokinetics (DPMK), clinical pharmacology/Phase 1, adult/pediatric, global Phase 2–4, and investigator-initiated trials. Currently, John and GeoSera are using their experienced clinical research network to benefit sponsor companies, clinical research sites, clinical trial service providers, and CROs. You can reach him at firstname.lastname@example.org or 484-568-3952.