Study Startup Archives

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Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial

Case Study, News article / By Ashley Stufano

At a Glance

No trial is ever easy. But with the continued effects of the global pandemic and the war in Ukraine, the sponsor had larger than average challenges. Nonetheless, PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. In the end the study completed enrollment of nearly 900 patients on time at as many as 370 sites all around the world. Italy and Australia showed up as the top enrolling countries.

Patient Enrollment Numbers

Sponsor Challenges

Enrolling over 900 patients and in a clinical trial of this complexity would pose a challenge even in the most mundane of years. Add to that continual pandemic consequences and a global conflict, the stage is set for every possible delay and communication breakdown. The sponsor needed a CRO willing to tackle an aggressive recruitment plan and provide a solid partnership in order for the trial to succeed.

Start-Up in Sync

Staying on time means starting on time. Working closely with sites to understand how the pandemic affected their ability to meet site activation, PSI offered them several technical options that allowed for remote site selection visits. PSI managed to identify over 3000 sites and select about 500 sites 3 months ahead of schedule.

Additionally, feasibility projections were actually reflected in enrollment, not merely a best-case scenario or wishful thinking. This is due in large part to knowing the sites. Today, PSI would have also added machine-learning-powered tool, VISIONAL™, to generate the most optimal enrollment scenarios that could potentially further reduce the study time and cost.

Racalibrating the Geo-mix

Not every CRO can offer flexibility and adaptability, especially in a short amount of time. During enrollment, a change of strategy on the sponsor side called for more sites, and swiftly. In order to do this, countries with initially smaller projected sites and patients had to ramp up with little to no interruption. The only way this could be accomplished was with previously established solid global site relationships and coordination and stellar communication on every level of the study team.

Managing Motivation, Staffing, & Velocity

To motivate teams on a country level, PSI staff focused on maintaining a sense of competition between teams. This helped create a friendly sense of excitement as countries saw their recruitment numbers grow.

Continuity of the study team also played an enormous role in the study’s success. This not only helped keep the study on track when the client had changes to their own staff but provided a sense of consistency and reliability throughout the course of the trial at every level. Key roles project supervisor, project manager and other key staff stayed on for the whole of two years of study duration, something almost unheard of in this ever-changing industry. They are still with PSI running the trial as we write these lines.

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI CRO Announces Launch Of VISIONAL™ Study Modeling Tool

Leave a Comment / Press Release / By Paul Mirek

ZUG, SWITZERLAND, September 29, 2022 – PSI CRO AG announces the launch of VISIONAL™, a study modeling tool that is part of the company’s proprietary technology platform, INTELIA™, used for clinical trial planning, budgeting and tracking of clinical trial finances.

“Now, more than ever, biotech sponsors need to see study budgets that are realistic, reliable, and predictable. Sponsors are tired of CROs change-ordering them at every turn, and CROs need to improve their predictions of what it would take to complete a clinical trial on time,” says Alla Smyshlyaeva, PSI’s Senior Director of Proposals. “With the help of leading software development company DataArt, we have created a technology platform that offers a suite of study planning tools and is indispensable to the efficient planning of global pivotal clinical trials.”

VISIONAL™ HELPS ACCURATELY PREDICT STUDY ENROLLMENT TIMELINES

VISIONAL™, the latest addition to PSI’s INTELIA™ platform, is a machine-learning-powered system for data-driven feasibility and enrollment forecast. It models and compares hundreds of country and site combinations, their budgets and probability of success within just a few minutes. In the end, it recommends the most optimal enrollment scenario in line with sponsor key objectives

HOW IT WORKS

VISIONAL™ is a cloud-based module that integrates and processes feasibility data tailored to a specific protocol, taking into consideration local medical practices, available patient populations, clinical trial experience, and other variables.

It collates historical enrollment rates in the given patient population from both internal and external data sources.

VISIONAL™ integrates historical startup timelines across more than fifty countries where PSI operates, as well as specific site knowledge data.

Sophisticated constraint-based algorithms are then applied to these data sets to model hundreds of country- and site-specific enrollment combinations to find the ideal scenario. Within minutes, clients have access to:

the fastest possible patient enrollment scenario
cost-effective enrollment options
optimal patient enrollment scenarios that balance out associated costs and study duration

VISIONAL™ can also be used to validate the client’s requested specifications, to estimate probability of success for the expected scenarios, and to recommend alternatives.

IMMEDIATE AND LONG-TERM BENEFITS

Modeling Beyond Human Abilities VISIONAL™ is extremely fast: it has the capacity to model and compare hundreds of possible enrollment scenarios and suggest the most optimal scenario within only a few minutes

Predictions without Human Errors and Bias VISIONAL™ de-biases enrollment projections: scenarios are automated and data-driven

Probability Projections VISIONAL™ estimates the probability of enrollment projections using historical data

Up-to-date Algorithms VISIONAL™ is up to date: the algorithms are based on the latest data and are being “retrained” on an ongoing basis to capture the latest insights

Live Budget Simulations VISIONAL™ incorporates costs in the decision-making process

“We are very excited about VISIONAL™,” says Kasia Moscicka, Global Head of Feasibility Department at PSI. “Reliable planning of clinical trials has always been PSI’s core expertise. Now, with the addition of this powerful tool, we are fully equipped to produce highly dependable, protocol-specific enrollment scenarios that consider the many intrinsic strategic needs of our customers.”

ABOUT PSI’S INTELIA™

INTELIA™ is PSI’s proprietary cloud-based platform created with the help of a leading global software development company DataArt.

The platform brings together a suite of clinical trial planning tools:

VISIONAL™, study modeling tool

CLARITY™, study budgeting and forecasting tool

CADENCE™, study budget tracking tool

INSITE™, investigator grant calculator

ABOUT PSI CRO

PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors.

Global headquarters are based Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com

For Media Inquiries:

Ashley Stufano, Marketing Specialist

919-972-9572 | ashley.stufano@psi-cro.com

Strategies for Expediting Study Startup in Australia With Barrie Koh

Leave a Comment / Case Study, Video / By Paul Mirek

Did you know that Phase 2 and 3 study startup times in Australia can be expedited with the right site relationships? In order to accelerate the first patient in, PSI engages private sites and medical centers to ensure an average startup timeline of only five months. Learn more about study startup in Australia with Barrie Koh, Country Manager.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, I’m Barrie. Did you know that Australia is quick to start up?

Everyone in the industry knows that it is easy to get an approval for an early-phase study in Australia. It is supported by streamlined regulatory processes, and you just need fewer documents for submissions. What most don’t realize is that startup in Phase 2 and Phase 3 isn’t that different.

The challenge is that most clients have a habit of going back to the same key opinion leaders or the huge institutions. they have lots of studies and they are heavily bureaucratic. To get to the first patient in quickly, PSI has been engaging the private sites, which are much more agile, only working with four to five huge private medical centers and a dozen more smaller sites.

With this particular approach, five months is feasible and it is consistent across all phases, all therapeutic areas and drugs classes. To cite you an example, in a recent microbiome study, we actually managed to achieve the first patient in in five and a half months at a private site down in Sunshine Coast. And this came in two weeks ahead of our planned first patient in.

Another example is a gene therapy study that we’re currently running. We were the first CRO to apply for a gene therapy license (in Australia). So we actually worked with each other to try to move this forward and this was done under four months itself and ever since then, we’ve completed four more gene therapy studies.

How to Apply for Phase 1 and Phase 3 Studies in China at the Same Time With Lisa Lu

Leave a Comment / Case Study, Video / By Paul Mirek

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Hear Lisa Lu, PSI CRO’s Country Manager in China, discuss how to determine if your study may qualify and how PSI’s local experts can help.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hello, my name is Lisa Lu. I’m the country manager for PSI in China and I’m located in Shanghai. Let me share with you some relevant aspects for running clinical trials in China.

Did you know that for new drugs coming to China, it is needed to conduct a PK study in a Chinese population locally? One can apply for an IND for Phase 1 and Phase 3 studies at the same time.

Based on NMPA’s feedback, you can potentially run Phase 1 and Phase 3 studies in parallel. Urgent medical needs like hematology studies, and lethal diseases without any drugs available at the moment, have a higher chance in running Phase 1 and 3 studies at the same time.

Usually, a PK study needs 20 to 30 healthy volunteer subjects or patients, depending on the different indication and medicine.

How Do India Study Startup Timelines Compare? With Radhika Bobba

Leave a Comment / Case Study, Video / By Paul Mirek

How did we achieve site activation for a radiopharmaceutical study in India in less than 5 months? It turns out India study startup timelines are faster than many European countries.

Learn more in this video with Radhika Bobba, PSI CRO’s Regional Director, India and Far East Country Management.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

India startup timelines are always discussed. “India is so slow, it’s so difficult to set up a study, it’s so difficult to start a study.” Let me give you a recent example.

We submitted a dossier for a radiopharmaceutical molecule in oncology on the 3rd of August, 2021. We received approval for this particular dossier on the 2nd of December, 2021 from a regulatory authority, the DCGI. It took us five months. The first site was initiated on the 14th of December, 2021, and the same site was activated on the 28th of December, 2021.

5 months, is it so long?

Yes, we are definitely not the fastest. We are definitely not the slowest. We can be compared to other countries in Europe. We can be compared to France, Italy, Germany, Switzerland. We are faster than Romania.

Debunking Latin American Study Startup Myths With Oscar Podesta

Leave a Comment / Case Study, Video / By Paul Mirek

Did you know that startup timelines for some countries in Latin America are comparable to those of many in Europe?

Hear from Oscar Podesta, PSI’s Head of Latin America, as he shares insights debunking some of the common myths about startup duration in the region.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, my name is Oscar Podesta. I’ve been responsible for the Latin American region at PSI for almost 10 years now, and I wanted to briefly address one of the most frequent comments I receive about my countries here that is related to the startup timelines.

I think that these days we can call it a myth around Latin American countries being too slow to get started in clinical research trials, but I do remember those years where this was true—I mean when Latin American countries used to take just too long to get activated, but that’s not the case anymore, and it has not been the case for quite some time already.

These days, if you look only at statutory timelines, we can say that countries like Panama or Chile can be activated in less than six months, which is comparable in line with many countries in Europe. And even looking at bigger countries, like Argentina, for instance, our statutory timelines there are comparable with Germany, actually could be even shorter than the UK.

So, looking at overall just First Site Activated in countries in the region, our timelines are not longer than the rest of the world in general. But I think we have to look at that in more detail. And if we look at the data we have at PSI, our track record and metrics, and we actually look at the average time to activate all sites in a country—not just the first site activated, but all sites—that provides even more interesting information.

At the end of the day, we need all sites activated to make the enrollment for the study, so it is important to have the whole country active. And looking at those data at PSI, we find out that countries like Argentina, Chile, Panama, and Peru are actually shorter than several western European countries.

And let’s take another step into that and look at the bigger countries in the region, like Brazil or Mexico. Brazil right now is hitting more than 200 million people living there. So it’s huge, as everybody knows. And historically, everybody would say, “No, I wouldn’t go with the study to Brazil because it takes too long”—and it’s not the case. It’s not the case.

Right now there are a lot of indications, especially rare diseases, that are branded fast-track review by the authorities in Brazil, and a rare disease study can easily be activated in Brazil, maybe in six months, which puts the country in direct competition to pretty much any country in the world. So, the myth or the statement about Latin American countries being too slow, I don’t think it’s anymore not even fair to say.