News from 08. Oktober 2021

Review: Global SCRS Summit 2021 | October 01.-03.

Our Learnings from the SCRS Summit

After the special permission arrived just on time, Helena Sigal and Kathleen Peters were able to attend the SCRS Summit in Hollywood, Florida. They were grateful for personal conversations with old and new colleagues, intensive exchange of experiences and the overall organization. They drew the following conclusions from the comprehensive and specific content of the summit:

​1. There are too many supporting IT systems, that don´t communicate with each other

Study sites are overwhelmed with the various platforms required by their respective sponsors, CROs, regulatory agencies, or local and national authorities. Study site staff must be taught and trained for each tool. In addition to time and cost issues, another challenge is that the desired software bandwidth is not always available. Working with many different sponsors and CROs is therefore almost impossible for some study centers. What is the practial solution of our network study centers? Some of them already work with the same study software, which combines several IT systems. For example, the IT system ECRS is a tool that is required by sponsors. The study software we use aims to interface with this system. Double-entry bookkeeping and errors can thus be avoided. the daily study routine will be much more effective thanks to the study software.

2. Big hype about decentralized studies

Many patients benefit from participating in trials of innovative therapeutic approaches, that are not yet available in their markets. What should be done when patients are too sick, old or infectious for a study visit? There are already solutions such as decentralized or hybrid clinical trials or home visits to make the world of clinical research more patient-centered. Study physicians or study nurses are increasingly visiting their patients at home. The enormous costs and time involved are problematic. In addition, the regulatory authorities are still reaching their limits due to non finalized guidelines. Decentralized studies certainly offer advantages to certain participants. Nevertheless, the industry still needs to sort itself out. Decentralized studies will certainly continue to have their place in study implementation in the future - but they will not replace classic studies.

3. COVID and the impact on the entire industry

The pharmaceutical industry has also clearly felt the effects since March 2020. Some clinical trials have been canceled or postponed. For pure study centers, this resulted in extreme financial problems or study holdups. Fear of the virus or changes in their personal situation also caused many participants to drop out, making recruitment for ongoing trials more difficult. Nevertheless, the pandemic also awakened a change in society's thinking, as the enormous technical, research and time pressures meant that some vaccines could be developed and approved in record time. The perception of clinical research was clearly positively influenced and a greater awareness of our industry was created.