News/Conferences

ZEG Berlin is proud to announce the launch of its Real-World Evidence (RWE) and Safety Data Analytics division. Areas of focus will include Epidemiology, Health Economics and Outcomes Research (HEOR), and Safety, as well as a range of therapy areas. This expansion bridges ZEG Berlin’s classical primary research division with the exciting future of RWE and Real-World Data (RWD).

Dr. Marc Pignot and Dr. Michael Schultze have been appointed to lead the new RWE and Secondary Data division. Dr. Marc Pignot brings more than 20 years of experience in the pharmaceutical and CRO business. He will lead the implementation and development of RWE & Safety Data Analytics. As Chief Strategy Officer, Dr. Pignot will establish a strong secondary data stream to complement and combine with ZEG Berlin’s long-established primary data business. Dr. Michael Schultze is leading the new RWE team focusing on secondary data-driven non-interventional studies. He also leads the development of medical algorithms and the interpreting of big medical data sets. Dr. Schultze’s interdisciplinary experience combines the three essential areas of expertise for secondary data-related studies: medical expertise, advanced project management skills, and a profound understanding of working with RWD.

“By combining decades of expertise and cutting-edge methodology, ZEG Berlin can enrich well-established research approaches with state-of-the-art Real-World Evidence methods. This makes ZEG Berlin a unique bridge-builder between the classical world and the promising future of clinical research,” said Dr. Marc Pignot.

Founded in 1990, ZEG Berlin specializes in the early detection and quantification of safety risks associated with the use of therapeutic, preventative, or diagnostic drugs. ZEG Berlin, part of the Cerner Enviza ecosystem, leverages its many global research associations while continuing to be deeply rooted in the German health sector. ZEG Berlin is best known for the development of the INAS/EURAS direct-to-patient study methodology in the late 1990s that was critical in resolving safety concerns regarding combined oral contraceptives.

“We have assembled a team of scientists and medical specialists at ZEG Berlin who are recognized for their proven achievements in advanced scientific studies and high-level RWE research,” said Dr. Michael Schultze. “The RWE team serves as a trusted advisor to clients, combining scientific research on an academic level with a solid understanding of pharmaceutical business needs.”

ZEG Berlin will build on its long-standing success in classical research methods to combine primary and secondary data in hybrid approaches, offering full services from protocol development to final publication. The design and implementation of innovative RWE tools and services deliver unique access to data and identify new data sources. The integrity of ZEG Berlin’s long history in developing and implementing post-authorization safety studies using primary data remains. However, the addition of sophisticated RWE research and analytics services provides new access to RWD and methodologies essential to meeting the constantly changing requirements, both internally and of regulatory authorities. By this means, ZEG Berlin is very well prepared for the promising future of clinical research and RWE.

• The real world PRO-E2 safety study of over 101,000 women in 12 countries has confirmed that the risk of venous thromboembolism (VTE)^* is at least as low with Zoely▼^® (NOMAC-E2) as with levonorgestrel-containing combined oral contraceptives (COC-LNG)¹
• The study also demonstrated a statistically significant lower risk of unintended pregnancy compared with commonly prescribed COC-LNGs ²
• NOMAC-E2 is the only monophasic combined oral contraceptive (COC) to contain estrogen with an identical structure to the one naturally produced by women^3,4

LONDON, UK – 14 October 2021. Theramex, a global women’s health company, today announced that the safety results from the PRO-E2 real-world safety study for Zoely^® (NOMAC-E2) have been published in The European Journal of Contraception and Reproductive Health Care (EJCRH).¹

The post-authorisation safety study (PASS), known as PRO-E2, was a large, prospective, non-interventional controlled cohort study of over 101,000 women. PRO-E2 compared the risks of using NOMAC-E2 versus COCs containing levonorgestrel (COC-LNG), a commonly prescribed contraceptive.¹

The primary objective of the real-world study was to assess and compare the risk of cardiovascular events* in NOMAC-E2 users with COC-LNG users. For the main clinical outcome, the risk of VTE^† was as least gas low with NOMAC-E2 as with COC-LNG, consistent with findings of previous studies (0.59  Hazard Ratio [HR]† 95% confidence interval [CI], 0.25-1.35).¹

PRO-E2 also demonstrated that contraceptive failure (the risk of unintended pregnancy), a key secondary outcome, was statistically significantly lower with NOMAC-E2 compared with COC-LNG (0.45 HR†, 95% CI, 0.34-0.60, [p<0.0001]). Further analyses showed that the lower rate of unintended pregnancy with NOMAC-E2 was even more pronounced in women under 35 years of age.² The shorter hormone-free interval with NOMAC-E2, its longer half-life, and monophasic regimen may all contribute to fewer unintended pregnancies.^5,6,7  

These results will be published in the EJCRH later this month.

All 14 secondary outcomes of the study were met, with the risk of severe adverse events and depressive disorders or changes in weight or acne score with NOMAC-E2 comparable to COC-LNG.²

PRO-E2 was conducted by ZEG Berlin using an active-surveillance, direct-to-patient study methodology.  Women were recruited by their prescribing physician and followed for up to 2 years to observe the incidence of safety-related events. Self-reported safety events were then verified by medical source documentation.

The safety and efficacy publications were accepted by the EJCRH in September. The publication on safety results is available online:

Results have also been submitted to the European Medicines Agency (EMA) and will be presented at the European Society of Gynecology Congress in November this year.

*Specifically deep venous thrombosis of the lower extremities and pulmonary embolism

†HR adjusted for age, body mass index, current duration of hormonal contraceptive use, family history of VTE

References:

1. Reed S et al. Eur J Contracept Reprod Health Care. Available from: https://www.tandfonline.com/doi/10.1080/13625187.2021.1987410 Accessed October 2021
2. PRO-E2 final report. Available from: http://www.encepp.eu/encepp/openAttachment/studyResult/41498;jsessionid=uW82EciuLgcm015Qta9_pO v1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890
3. Theramex. (2021) Zoely^® SmPC. Available from: https://www.medicines.org.uk/emc/product/3038/smpc. Accessed October 2021
4. Westhoff C et al. Obstet Gynecol 2012; 119(5): 989-99.
5. Christin-Maitre S et al. Womens Health (Lond) 2013; 9(1): 13-23.
6. Van Vliet HAAM, Raps M. Cochrane Database Syst Rev 2011; (11): CD009038.
7. Duijkers IJM et al. Eur J Contracept Reprod Health Care 2010; 15(5): 314-25.

Our most recent INAS-SCORE publication has been selected as a ‘highlighted’ article for this month’s edition of the European Journal of Contraception and Reproductive Health. 

The article will be freely available to download next month (August 2019), via this link: https://doi.org/10.1080/13625187.2019.1629412

You are very welcome to download a full-text personal copy of the article, next month (August 2019) as an open-access article.