ASCO Annual Meeting 2022
During the first week of June, we witnessed the opening of the annual meeting of the American Society of Clinical Oncology (ASCO) for the first time since 2019.
ASCO is known as the world’s leading Oncology event that brings together leaders in the cancer care field and becomes a scene where the most advanced discoveries and innovations are being presented and discussed.
To put the importance and scale of this event into perspective, the number of study abstracts submitted to the ASCO Congress this year was 7000 and the number of registered attendees was 36 000 people.
Clinscience’s Contribution to ”Best of ASCO”
Clinscience, majority shareholder in Exom Group, earned an honorable place in this year’s Congress. The results of the ATLAS Clinical Trial sponsored by the Polish Myeloma Consortium and managed by Clinscience were selected for an oral presentation at the ASCO 2022 and were qualified for the elite group of the most interesting abstracts “Best of ASCO”.
In the following lines, we will introduce you to the behind-the-scenes overview of what made this Clinical Trail an achievement.
Alicja Mazurkiewicz, Associate Project Director at Clinscience, tells us more about the challenges they met along the way and the best practices and solutions that led the Team to success.
The ATLAS Clinical trial
What was the purpose of the Study?
Alicja: ATLAS is the first Polish Myeloma Consortium’s (PMC) Clinical Trial. This phase 3 randomized trial recruited newly-diagnosed Multiple Myeloma Patients who received any induction therapy for up to 12 months followed by a single ASCT. Patients were randomized to receive either KRd or R, stratified by the post-transplant response. The primary objective was to make a comparison of disease progression-free survival time in the two treatment arms.
What was Clinscience’s role in the Study?
Alicja: As the Sponsor did not have particular experience in Clinical Trials, we provided extensive support and guidance throughout the way. From the very beginning, Clinscience was involved in the organization of the whole study in Poland, including: the preparation of study documentation, development of procedures for ordering and delivering investigational products, logistics of biological material, submitting an application to EC and RA, contracting vendors and sites, monitoring, study management and much more.
I’d say that Clinscience was managing the organization of the entire project from start to finish, and we can tell the results were successful – the necessary number of Patients was recruited in an effective manner.
The Challenges of a Non-Commercial Clinical Trial
What would you say was the biggest challenge?
Alicja: We faced more than one challenge. The biggest was that the Sponsor had no prior experience in Clinical Trials and was a non-commercial Sponsor, thus there was a need for him to be introduced to all his obligations under the ICH-GCP. All documents were supposed to be prepared by Clinscience, and in some cases, we had to make the Sponsor familiar with the exact documentation required in relation to the procedure of regulatory approval obtaining and study conducting requirements.
Also, there were challenges regarding RA approvals. Non-commercial Trials were very rare at that time (2016). In 2016, 458 Clinical Trial applications were submitted to polish RA and only 16 of them were concerning Non-commercial Clinical Trials.
We had to manage carefully the Sites contracting as well. Again due to the fact of the non-commercial nature of this trial, sites were not eager to participate. To address this as CRO we developed a 3-party agreement template tailored to the non-commercial character of the Clinical Trial. We were visiting Site’s administration departments personally. Thanks to this organization everything went smoothly.
The whole organization of the study was another challenge by itself – creating all the procedures, including the preparation of the entire logistics. Contracting Sites – Sites were concerned about the non-commercial character of the trial, due to the recruitment of Patients with Multiple Myeloma.
What contributed to the success of the Trial?
Alicja: Excellent regular communication with Sponsor through various channels and formats made the whole communication process very effective. Also, the precise organization and management of the ATLAS study by Clinscience greatly contributed to the overall success. This achievement won’t be possible without great Clinscience Teamwork. The work alignment between our Teams and experts allowed us to recruit 180 Patients 159 in Poland and another 21 – in the USA.
I have to say that we are honored that our Partner, PMC, has trusted us and we are providing our smart Solutions to the other Studies sponsored by them (OBI-1, PREDATOR, COBRA). This is perhaps the biggest award for our success – the trust of the Partner.
Why do you think the ATLAS study abstract was awarded?
Alicja: The result of this study is groundbreaking and may represent a new standard of care for Multiple Myeloma. We are proud to be a part of the life-changing therapies development and new standards of care setting.
Read our Article at Fiercebiotech: https://www.fiercebiotech.com/cro/non-commercial-sponsors-need-more-support-says-asco-winner-clinscience
Read more on our Technology Platform Genius Suite and how we can improve your clinical trials. For non-commercial and investigator initiated trials Exom offers Pentalpha, a dedicated version of Genius Suite. Want to learn more? Contact us.
Clinscience is a global CRO company offering smart CRO Services, from protocol creation to final study report development. The Company has offices in Poland, Spain, Italy, Germany, and the US and provides its services in 6 European countries. More than 150 Biotechnology companies across Europe and the US trust the Clinscience brand. The Company’s procedures and Data-driven approach, harnessed with the Genius Suite™ technology, work together to give the Clients power and flexibility to address even the most unique needs. Clinscience is part of a publicly-traded parent company, Neuca Plc, an organization in the pharmaceutical wholesaling and healthcare industry that provides the structure to meet the needs of commercial and non-commercial studies.
Visit www.clinscience.com for more information.
About Neuca Group:
The Neuca Group has been operating around healthcare over 30 years, synergistically combining the needs of pharmacists, manufacturers, and Patients. It is the market leader in the wholesale distribution of pharmaceuticals in Poland. The key partners for the NEUCA Group are independent pharmacists, whom the Group supports in their daily operation of pharmacies, providing tools to build competitiveness and profitability.
The Neuca Group cares for its patients’ health by developing a network of medical clinics. It is an expert in the clinical research segment, executes ambitious telemedicine projects, and successfully operates in e-commerce and health insurance industry. It is also an experienced producer of medicines and pharmacy preparations.
Since 2004, Neuca has been a public company listed on the Warsaw Stock Exchange, perpetually improving its financial results.
Visit www.neuca.pl for more information.