In an era of patient centricity and value based innovation, it is imperative that pharma companies approach drug development holistically with the patient perspective, needs and experience in mind. Historically, clinical trials have been designed with priorities revolving around feasibility and ease with which the sponsor can conduct the study. Similarly with trial design and endpoints, objectives for R&D have focused on seeking regulatory approval – there has been little to no focus on the systematic inclusion of patients, specific vulnerable populations and/or addressing real world unmet needs of the patients. This evidentiary and operational disconnect within R&D and clinical teams has led to costly and extended trials, and ultimately limiting patient access to new medications.
The workshop will focus on in depth discussions, with case studies focusing on business and didactic benefits of adopting a patient-centric drug development ecosystem and fundamentally transforming the way you design your clinical trials. In that regard, several components of developing a patient centric trial will be presented and discussed as follows:
- Strategic overview of the concept of patient centricity and how to relate that to drug development
- Mapping of the patient journey and incorporating learnings from different patient touch points into trial design, conduct and execution
- Case studies and discussions on patient friendly recruitment, consenting and protocol development
- Patient centered protocol trial simulations and refinement of final study conduct
- Understanding of patient reported outcomes and inclusion of “fit for purpose” PROs into trial end point strategy and clinical and regulatory process
- Leveraging patient insights and real world evidence to crystallize trial design, populations and end points towards real world unmet needs of the patients
During the final hour of the workshop, Usman will lead a hands on exercise simulating a hypothetical scenario, where participants will work in groups to translate a traditional trial design into a patient centric one from a clinical, operational and evidentiary standpoint.
Senior Director, Medical Affairs & HEOR
* There is a 15 minute coffee and networking break from 10:45 am - 11:00 am
Genentech Research and Early Development is incorporating the patient voice before a study starts, through a simple mock simulation that includes the patient, coordinator and medical monitor. During this session you will hear real time data and evidence on the impact of patient insight on the protocol design of your clinical trial. Meghan will lay out the challenges and pit falls, providing attendees with best practices and clear take-aways, should they be interested in implementing a similar study in their organizations.
Associate Director, Senior Clinical Program Leader
By recognizing the patients’ essential role in the development of drugs, the patient becomes the center of attention. Organizations must implement processes to incorporate patient insights into each step of the drug development process. In addition to that, It is key to include the right patients within the clinical trial to equally represent the population being examined. By increasing the diversity of patient populations, researchers are promoting the health and safety of minority populations. Through this discussion attendees will walk away with greater knowledge of the efforts the FDA is pushing forward to promote and protect the health of racial and ethnic minorities.
- Transform regulatory processes to become more patient focused
- Include diverse populations within clinical trials
- Improve health and safety communication among minority populations
Director, Extramural Research Program, Office of Minority Health
Recruiting patients for clinical trials remains a large obstacle for clinical research teams. It has become common for industry stakeholders to incorporate patient feedback in clinical trial recruitment and retention strategies. Only through understanding of the needs of the patient, can the industry tackle recruitment and retention challenges. As part of this panel you will hear both a manufacturer’s perspective as well as an advocacy group’s perspective on dealing with patient recruitment and retention issues and ways to work corroboratively to aid with these challenges.
- Enhance the patient experience and increase clinical trial retention rates by tailoring recruitment strategies directly to patients needs
- Develop strategies to embed patient feedback into recruitment processes
National Director, Advocacy and Alliance Development, Respiratory and Professional Affairs
Dr. Grossman will speak about the company’s work to bring an IUD to market in the U.S., specifically designed to address an unmet patient need – access to long-acting reversible contraceptives, or LARCs. She will discuss the decision-making behind bringing an IUD to the U.S., specific challenges her company encountered, and the patient needs they identified that motivated the company to approach clinical trials in a novel way. Dr. Grossman will also discuss the specific patient-centric parameters the research team used to design their pivotal trial to better address the challenges U.S. HCPs and women had in accessing IUDs.
- Innovative pharmaceutical companies will consider a range of unmet needs for patients, including access issues
- HCPs provide critically important perspectives on patient needs to inform clinical trial design, but in gathering their perspectives, it’s key to engage a broad range of HCPs who can represent the true diversity of the affected patient population
- HCPs are demanding clinical trial data that represents the real-world population of patients they treat
Chief Executive Officer