Evolving our approach to clinical trials
18.05.18
According to the World Health Organization, more than 3.7 million Europeans are diagnosed with cancer every year. Another 1.9 million will die each year, making cancer the second most important cause of death and morbidity in Europe. We have taken great steps in tackling some types of cancer: according to the latest statistics, 80% of patients diagnosed with breast cancer are still alive after 5 years. Yet we are not moving quickly enough: for ovarian cancer the same 5-year survival rate is less than 50%.
As an industry, we want to dramatically speed up the process of bringing new treatments to patients, in particular by looking at how we can make clinical studies more efficient and more patient-friendly. This feeds our broader ambition to make Europe the leading global centre for clinical studies as we develop the next generation of breakthrough treatments.
Our action plan seeks to involve all the stakeholders critical to drug development. Finding ways to involve patients across the entire development spectrum can help us ensure that what matters most to them drives our actions from day one. We want to work with regulators to find ways to harness the power of big data. For the scientific community, we have put procedures in place to enable them to access raw data from our studies to conduct research. And for healthcare professionals, our commitment to publish full results of all clinical studies for all our products is being systematically implemented by all EFPIA member companies.
Beyond these activities, we also want to take tangible steps to address some of the key bottlenecks in clinical studies.
Precision medicine, which relies on biomarkers to diagnose and treat cancer, opens the way for truly transformative treatments in the years to come. One particular challenge is recruiting the right patient for the right study at the right time.
To be considered for a specific study, patients today are screened after they have had tissue removed and sent for a biopsy. In a typical case no more than 5% of people with a given cancer possess the biomarker that would make them eligible for that specific study. The remaining patients have few options. They could be screened for another study, but many patients with severe and life-threatening diseases do not have the time for a long and complex process involving a different screening for each individual study.
That is why we are working with partners on a project called the Integrative Patient Screening Initiative, IPSI for short. Bringing together pharmaceutical companies, investigators, regulators and patients, IPSI would establish a common platform for sharing of screening and biomarker results. This would allow patients considering participating in a clinical study to know that results from a single screening will be evaluated across multiple studies, increasing their chances of finding one that matches their personal medical profile.
IPSI addresses the needs of patients who are increasingly keen to participate in a clinical study as a potential treatment option but whose chances of qualifying for a given study are extremely low in precision medicine. IPSI also addresses the needs of investigators who can become discouraged when they participate in precision medicine clinical studies and screen a high number of patients without any patient being enrolled. Lastly, IPSI addresses the needs of pharmaceutical companies, for whom increasing the rate and speed of recruitment into studies to ensure the viability of development programs in difficult-to-recruit diseases is critical.
To be successful, an initiative like IPSI will need to bring a varied set of stakeholders together. While we all bring different perspectives, what unites us is a commitment to making our quest for new cancer treatments faster and more efficient, so that we can deliver on the promises of the next generation of cancer treatment.
