FDA’s Post

Do you have a patient with a serious or immediately life-threatening disease or condition? Expanded access, sometimes called compassionate use, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to try an investigational medical product for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Patients should meet the following criteria:    ☑️ There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.  ☑️ Patient enrollment in a clinical trial is not possible.  ☑️ Potential patient benefit justifies the potential risks of treatment.  ☑️ Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.   Learn more about expanded access resources for patients & health care professionals ➡️ https://lnkd.in/eCDqQUDD   Check out this guidance document featuring questions and answers regarding expanded access ➡️ https://lnkd.in/gXmZ-Gpr

Do you have a patient with a serious or immediately life-threatening disease or condition? Expanded access, sometimes called compassionate use, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to try an investigational medical product for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Patients should meet the following criteria: ☑️ There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. ☑️ Patient enrollment in a clinical trial is not possible. ☑️ Potential patient benefit justifies the potential risks of treatment. ☑️ Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication. Learn more about expanded access resources for patients & health care professionals ➡️ https://lnkd.in/eCDqQUDD Check out this guidance document featuring questions and answers regarding expanded access ➡️ https://lnkd.in/gXmZ-Gpr

Clinical trials play an important part in helping to find out if new medicines are safe and effective. Yet a lack of awareness and feelings of hesitancy about joining one persist. Hear from a former clinical trial participant and a doctor who share why they think it’s important for others to consider participation.

Participants are the MOST important aspect of any #clinicaltrial. Having a large, diverse group is important, but many companies struggle to find participants. If you have ever considered becoming a participant and have questions, check out this conversation with our friends at Merck:

Clinical trials play an important part in helping to find out if new medicines are safe and effective. Yet a lack of awareness and feelings of hesitancy about joining one persist. Hear from a former clinical trial participant and a doctor who share why they think it’s important for others to consider participation.

Patients are more likely to express interest in clinical trial participation - if they are asked about their specific condition vs. a generic clinical trial. Our marketplace has tens of millions of patients with known conditions. Let SubjectWell ask specific patients about your specific clinical trial. Learn more at https://lnkd.in/gtPmM-_v #clinicalresearch #patientrecruitment

Pivotal trials that stand on their own could help biopharma manufacturers communicate the clinical value of medicines to payers and implement market access restrictions that allow patient access and result in better commercial performance. Embeding a patient access mindset and demonstrating total value to payers are ways to earn patient access through clinical trials.

🔍🌟 Did you know that patient-centered clinical trials can significantly improve recruitment and retention rates? It's a fact! A staggering 80% of delays in clinical trials are attributed to recruitment and retention challenges. At PPD we have the solutions to help you overcome these hurdles and maximize your trial participation. Here's how: 🔎 Screening for multiple trials within the sponsor: Our streamlined process allows us to efficiently screen patients for multiple trials within your organization. Greatly reducing the time and effort needed to identify eligible participants. 💡 Increasing patient satisfaction and removing barriers: Our solutions empower patients, remove barriers and provide resources for patients to make informed decisions. Reach out to us today and let's collaborate to make a meaningful impact in clinical trial success! 🤝🌍 #ClinicalTrialRecruitment #PatientRetention #PatientCentricity #ClinicalResearch 

Pivotal trials that stand on their own could help biopharma manufacturers communicate the clinical value of medicines to payers and implement market access restrictions that allow patient access and result in better commercial performance. Embeding a patient access mindset and demonstrating total value to payers are ways to earn patient access through clinical trials.

Pivotal trials that stand on their own could help biopharma manufacturers communicate the clinical value of medicines to payers and implement market access restrictions that allow patient access and result in better commercial performance. Embeding a patient access mindset and demonstrating total value to payers are ways to earn patient access through clinical trials.