MEDSIR Leads a New Era in Oncology with Smarter Clinical Trials

Drug Development and Real-world Clinical Needs Establish a New Era in Oncology

Image Credits: MEDSIR

Concern

The United States, till now, has completed 321.4% of phase 2/3 clinical trials. The percentage is less than compared of other regions' clinical trials. The patient recruitment and protocol design challenges hamper the performance of clinical trials. The protocol design is intricate due to its study procedures, number of endpoints, and eligibility criteria. Around 90% of protocols need one substantial amendment. These are the scientific complications that further form into operational challenges, like sites in competitive areas and the coordination of several countries. Oncology holds the highest variable values of protocols in comparison to non-oncology protocols. Also, it consists of planned visits, investigative sites, and the average number of countries. Patient recruitment is another hurdle in clinical trials. Due to late or limited early patient-centered planning, there is difficulty in protocol duration and enrollment.

MEDSIR

MEDSIR was introduced as a new-model company in 2012. The company, known for its end-to-end management of clinical trials in oncology. MEDSIR’s concept is sorted and strong. The transition in drug development strategies and the oncologists’ intuitive ideas will lead to the quality performance of clinical trials. MEDSIR’s clinical trials are mainly based on the investigators' ideas, along with the partnership with healthcare companies. This will accelerate patient-centered strategy and drug development. Every trial is initiated by the guidance of an investigator and supported by a team of experts who are part of the process. Protocol design combines clinical trial expertise from its initial stages, which helps to prevent common pitfalls which is related to the study and recruitment process. The operational team of MEDSIR focuses on the performance of patient recruitment, covering all countries and sites within a timeline. After the completion of the study, a data scientist team performs statistical analysis of the collected data.

Results are circulated by a scientific team via presentations at publications and international congresses. This will reward and enhance the investigators' teamwork. The recent studies of the company showcased investigator-initiated trials and their positive results for cancer patients. The trial involves therapy de-escalation strategies as demonstrated in the PHERGain study. This has enhanced treatment tolerance as seen in PRIMED and METALLICA trials.

PHERGain Study

The PHERGain study has addressed the chances of safely skipping chemotherapy in a listed group of patients. Further, it specifies two groups of participants and their respective findings that contribute highest to the personalized treatment strategies for HER2+ breast cancer.