Are We Moving From Strategic Partnerships Back To FSP Relationships?

By Ed Miseta, Chief Editor, Clinical Leader

What changes can you expect to see in clinical trials going into 2016? George Betts, Senior Director of Medical and Regulatory Affairs for Ipsen Biopharmaceuticals, believes patient recruitment and technology will continue to be a focus for sponsors going forward. He also believes that the specialty CRO market place will continue to grow as many sponsors are moving away from the “all or none” approach with strategic partnering relationships with large CROs and going back to more competitive FSP (functional service provider) relationships with smaller, specialty CROs. Betts, who has spent over 20 years in the pharmaceutical industry working for Ipsen, Novartis, and Sandoz, recently shared his views in an interview with me. 

Ed Miseta: What are some of the major trends you think will impact clinical trials in 2016?

George Betts: I believe the competition for patients as well as the continued pressure to increase efficiency and lower costs in R&D will remain as primary concerns for sponsor companies. There will no doubt be continued pressure to drive cost savings in R&D while maintaining quality in clinical trial design and execution. The patient enrollment challenge is further compounded by competing clinical trials in therapeutic areas where there is significant competition.

Miseta: Is there a solution to the recruitment issue?

Betts:  I think we will see more and more of a push toward ever more strategic placement of internationally managed clinical trials. With all the changes in regulations from one country to the next, shifting economies, and a growing global talent pool, there are opportunities to be had with the placement of clinical trials. North America and Germany still remain the top market for clinical trials, but they have seen a decline in activity as companies continue to look at the emerging countries as suitable locations to place trials. 

Miseta: Do you see 2016 being a breakout year for some of the newer technologies?

Betts: It’s no secret that historically the pharmaceutical industry has been late at adopting new technologies in the clinical space. Over the past several years however, several forward-thinking CROs, who focused their resources on gaining the leading edge technology solutions, have helped reverse this trend. Pharma companies have also started adapting these new technologies, sometimes through having their studies managed by those same CROs.

Miseta: Are there any specific technologies you see gaining traction?

Betts: The three big areas that I think will continue to develop nicely are in eTMFs, electronic signatures, and use of social media and smart phone apps for patient reported outcomes and diaries. Social media and smart phone apps have also provided a nice boost to patient recruitment and retention efforts. However, there is still a need for better integration of all the systems and tools used during a clinical trial, such as IVRS, CTMS, eTMF, EDC, Study Portals, and others.   

Miseta: Risk-based monitoring is not new, but seems to have really caught fire since TransCelerate released its guidelines to the market. Will the adoption of RBM continue to grow?

Betts: RBM has certainly been on the minds of almost every clinical trial leader for the past few years. This ties into the emerging trends we are seeing in EDC technology, but it is more involved as it must also take into account the methodology used to incorporate RBM into a clinical program. I also see a need to have clinical trial programs consider "patient-centric" study designs. Far too often, clinical protocols, which are the blueprint of a clinical trial, are developed with in-house clinical medics, clinical operations and biostatistician talent. From time-to-time, protocols are developed with the addition of external thought leader input, but it is still somewhat rare for companies to go to the patient for their perspectives. I think in disease areas where there are strong patient advocacy groups, there may be an opportunity to leverage direct patient feedback with the goal of making studies more patient-focused and patient-friendly.

Miseta: What are some of the things companies are doing to make that happen?

Betts: Some sponsors have tackled this challenge by creating positions (i.e. Chief Patient Officer), and in some cases whole departments, to drive patient centricity. These departments have budgets and the full endorsement of management. Other companies are only now starting to think more strategically about the topic. In fact, I believe there is no common understanding or definition of patient centricity in the pharma industry.  The challenge some companies have is defining what patient centricity means, while also defining the parameters of success to deliver value to patients. Some companies have advanced in this area and have defined areas to measure patient centricity within their organizations. Measurement areas include patient experiences, documented clinical and patient reported outcomes, patient adherence, patient access to medicines and services, patient input into company plans, clinical trials, and other product development and commercialization activities. There is no one set of standards here that one can go to, so I believe there could be an opportunity to align across the pharma industry on a common approach to the assessment of patient value creation.

Miseta: Is the industry continuing to move toward strategic partnerships or are some companies beginning to revert back to FSP models?

Betts: From my view point, I have seen more of a move toward FSP models. Although the traditional strategic partnership model has evolved, it still holds risks to pharma companies when designed with a single partner focus. No one likes the risk of placing all of your eggs in one basket. Those companies that jumped into a sole provider model in the 1990s and 2000’s were ultimately unsuccessful with improving quality and driving down costs. On the other hand, FSP sourcing models have gained appeal due mainly to flexibility and cost. At the same time I have also seen some companies move away from the top five “mega CROs” to smaller and mid-sized specialty CROs. This has been done in an effort to gain better service levels and lower costs. Specialty CROs that are focused on specific therapeutic areas – oncology CROs, for example – are gaining ground. This is also true of CROs that specialize in late-phase studies, such as Phase 4, patient registries, and expanded access programs. I think we will continue to see these specialty CROs gain ground and become more appealing to buyers.