Situated just 1,200 miles from the mainland US, a hotspot of clinical trial activity is being established on a small island paradise. If you haven’t heard of the Puerto Rico Consortium for Clinical Investigation (PRCCI), you should. What this organization is doing in clinical research trials for international drug development companies is huge.
The PRCCI is a not-for-profit consortium of high-quality research sites invested in increasing the speed and quality of clinical trials. To put that into context, the PRCCI acts as the single point of contact for sponsor organizations, mainly pharma companies and CROs, to connect with pre-qualified research sites and clinical investigators, thus ensuring the quality of the clinical trial overall. According to Kosmas Kretsos, PhD, MBA, Executive Director of PRCCI, “The PRCCI makes life easier for sponsors, in that they can rely on high quality standards for their clinical trials enforced for each and every clinical trials unit (CTU) in this consortium.”
And this strategy, implemented only in November last year, bears fruit: five study rewards were granted already, among them a first trial in Zika, and a total of sixty-four study opportunities are being pursued across all therapeutic areas.
A CRITICAL ROLE IN DRUG DEVELOPMENT
Clinical trials are huge investments for pharma, and trying to manage them can be, well, nearly unmanageable. From finding the right target population to administrative bottlenecks, patient drop-out rates, data integrity, and subject recruitment, the process can be overwhelming.
At the same time, for small CTUs, the administrative crush is very time consuming. They often juggle several studies concurrently, including the resultant paperwork and finances, and often no capacities are left for marketing and communication.
PRCCI creates an advantage for CTUs and sponsors alike, by creating fast and efficient processes and a single point of entry. As well, PRCCI’s “one entry, one stop shopping” philosophy ensures consistent quality.
“One important aspect is the quality. I think that is the key selling point,” said Dieter Falkenburg, PhD, of FalCon Bio Life Science Consulting who works closely with the PRCCI. “The PRCCI is like a membership. If you decide to become a member, you have to meet standards that control quality and rigor.”
Kretsos echoes this sentiment. “Our primary concern is to ensure quality and speed of execution for the sponsor or CRO. We carry out quality and performance monitoring and improvement working with an external partner, so that the monitoring requirements are less and the sponsor develops the drug candidate faster.”
There are many advantages of operating in Puerto Rico, yet many pharma companies are not aware of Puerto Rico’s clinical research capabilities and unique status. These advantages include operating under FDA jurisdiction and standards as well as expertise in disease areas where there is a global research focus such as cancer and infectious diseases. Among other things, the Puerto Rico Science, Research and Technology Trust, the parent entity of PRCCI, has established the Tropical Diseases Brain Trust which provides scientific leadership and enables advancements on diagnosis and prevention of diseases such as Zika, Dengue and Chikungunya.
Access to patients is another key differentiator. Puerto Rico has a population with high chronic disease prevalence that is similar in makeup to the US. In particular, Puerto Rico has high prevalence in diseases such as cancer, arthritis, depression, asthma, diabetes and cardiovascular diseases.
For CTUs the advantages are many. In addition to the key processes of study startup operations and quality, PRCCI takes on tasks CTUs are overburdened with, such as invoicing, marketing and public relations, and administrative work. These conditions allow many major CTUs to focus on what they have been doing best: conducting clinical trials for large pharma companies for years, resulting in outstanding expertise. “These relationships would not have held so long if there wasn’t a consistent high performance level,” said Falkenburg. “The relationship CTUs have with patients is excellent, both on the scientific side and on a personal level. This is perceived by pharma as beneficial.”
“The CTUs really want to grow and compete with the rest of the world instead of with each other,” said Kretsos. “We enable them to not only fulfill the prerequisites but also to get on the radar of sponsor companies and CROs.”
“Sometimes you have only one shot,” echoed Falkenburg. “This is why the PRCCI puts emphasis on quality and execution. You have to ensure what you promote you can also fulfill. This is the mission of the PRCCI.”
A PERFECT SETTING
Of particular interest is Puerto Rico’s predominantly Hispanic population. Hispanics are forecasted to make up to 25% of US population by 2030 from the current 17% (2013). At the same time, they are currently estimated to represent only 7.6% of clinical trials participants in the US. This is highly attractive for sponsors and CROs in need of ensuring fair representation in clinical trials and ultimately better patient outcomes. “Patient recruitment is easy, as well,” said Falkenburg. “And patients are extremely loyal; we have seen fast recruitment and great retention with sometimes a minimal 2% dropout rate.”
Clinical trials have helped to improve the life of many patients in Puerto Rico. The PRCCI has received positive feedback from patient advocacy groups such as Asociación Puertorriqueña de Ayuda al Paciente de Psoriasis and VOCES – Coalición Vacunación de Puerto Rico, as well as directly from patients. In response, the PRCCI has just announced plans to invest in and create a patient-centric platform, to empower patients to be informed, interact and share clinical trial experiences to increase awareness of clinical trials in Puerto Rico. The platform is intended to enable patients to volunteer for trials to advance science, help others, and gain access to new, innovative treatments.
IF YOU BUILD IT, THEY WILL COME
“A major benefit of working with PRCCI is the direct connection between CTUs and sponsors,” said Kretsos. “The PRCCI helps to get these connections started and grow, by matching the right drug candidates with the right CTUs and patients.”
BARDA and CDC have increased their presence on the island in working on clinical trials. Large global pharma companies such as AbbVie, Amgen, GlaxoSmithKline, Johnson & Johnson and Lilly, to name a few, are doing trials in Puerto Rico. And they are regulated by FDA, just like in the mainland US. The FDA has a satellite office in Puerto Rico and works very closely with sponsor companies to guarantee the quality in the registration and adherence to FDA-regulated study protocols.
A TRANSFORMATIVE VISION
All these factors in combination have set the PRCCI well on its way. The consortium has become a major pillar for Puerto Rico in achieving its vision to transform the island into a globally recognized innovation hub that develops, attracts, and retains scientists, technology entrepreneurs, and enterprises to unlock world class creativity and competitiveness by 2022.
Meet Kretsos and Falkenburg at Biolatam® 2016 taking place in San Juan, Puerto Rico, November 29–30. Biolatam is EBD Group’s fast-growing life sciences partnering event that brings executives from Latin America’s vibrant life science hubs together with global dealmakers. To find out more or register, click here.