Caregivers: An Untapped Resource for Clinical Research

Caregivers: An Untapped Resource for Clinical Research By Hannah Eccard, MA Caregivers provide substantial support to the health and well-being of patients in the US. One of their contributions involves helping patients search for, and participate in, clinical trials. Caregivers turn to Inspire for help finding and accessing clinical trials. My father was diagnosed [date] with stage 4 [type] cancer. He has been on numerous rounds of chemotherapy and last scan showed the cancer has progressed…We are now waiting news of any clinical trial he is eligible for…. He is in stable condition now without any issues... [...]

Merck’s Patient-Centric Clinical Trial Recruiting

Merck’s Patient-Centric Clinical Trial Recruiting By Kathleen Hoffman, PhD MSPH Merck boosts clinical trial recruitment with a patient-centric mindset Everyone in pharma knows that product success depends on the results of clinical trials -- but we don’t usually hear from the people who are involved in running them.  Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process -- a model that affects their trials top to bottom, from design through implementation. Each of [...]

Do Patients Care About What Your Drug Does?

Do Patients Care About What Your Drug Does? By Sara Ray, MA Be sure the trial outcomes echo the patient voice, article says In most randomized pharmaceutical clinical trials, researchers are looking for a statistically significant performance difference between the two courses of therapy. But which is more important to the patient: Statistically significant improvement of a variable, or clinically significant improvement? “The operation was a success, but the patient died” is a succinct example of a misplaced sense of priorities. The patient was probably hoping for a better result than academic satisfaction. Here’s another example. [...]

Clinical Trials and PROs: What Patients with Rare Diseases Say

Clinical Trials and PROs: What Patients with Rare Diseases Say By Kathleen Hoffman, PhD MSPH Challenges to developing clinical trials for rare diseases begin with their rarity – each condition affects fewer than 200,000 Americans. Approximately seventy-five percent of those affected by rare diseases are children. It is estimated that 80 percent of rare diseases are caused by genetic changes. Many rare diseases are progressive and debilitating. One third of the children affected by these conditions do not reach 5 years of age.1 Getting to a rare disease diagnosis can take years. In a way, it [...]

What Members Tell Each Other About Clinical Trials

What Members Tell Each Other About Clinical Trials By Kathleen Hoffman, PhD MSPH "Failing to enroll a sufficient number of subjects in a trial is a long-standing problem"1 but understanding the factors impeding enrollment can be difficult. Public posts on social media are an effective resource for understanding how patients feel and what they understand about clinical trials. On Inspire, “clinical trials” are a popular topic. Close to 58,000 posts mention clinical trials. A cursory search of Inspire postings show the diversity of opinions and understandings: some member posts provide solid information, some members post incorrect [...]

Are You Listening to Patients? Patient Preferences and Clinical Trial Design

Are You Listening to Patients? Patient Preferences and Clinical Trial Design By Kathleen Hoffman, PhD, MSPH Last fall, over 1500 Inspire members living with sarcoidosis, scleroderma, ovarian cancer, prostate cancer, colorectal cancer, arthritis and psoriasis, completed a  survey on exploring patient preferences and insights on clinical trials. Our recent webinar, "A Hopeful Mindset," described preliminary results. Thirty-nine percent of respondents had cancer, 32% had a chronic condition - arthritis or psoriasis - and 29% had a rare disease. Over the next few months we will be sharing more details from the data.  Last week in "5 Benefits [...]

5 Benefits of Patient Focused Drug Development Sponsors Need to Know

The Patient Is Speaking: 5 Benefits of Patient Focused Drug Development Sponsors and CROs Need to Know By Sara Ray, MA Since the 2012 FDASIA reauthorization of the Prescription Drug User Fee Act (PDUFA) and the 21st Century Cures Act ‐‐ Directing and Enabling Patient Focused Drug Development in 2016, integrating the patient perspective has been a priority. Our research team has conducted studies with patient and caregiver Inspire members for a variety of sponsors. I'd like to describe how these research projects produce important patient insights that inform and can improve clinical trials. Patient focused drug [...]

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018 “Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don't have brain mets, who don't have other diseases like diabetes or high blood pressure,” Dr. Kelly Shanahan, an obstetrician-gynecologist, activist, consumer reviewer for the Department of Defense Cancer Research Program and patient with stage 4 breast cancer said in an interview via email.1 Dr. Shanahan’s description matches many of the concerns [...]

Introducing Inspire Recruit

Introducing Inspire Recruit Commonly discussed statistics on patient enrollment and retention in clinical research paint a bleak picture. Clinical trial on-time completion rates are low--only around 20%. This is due in part to the fact that 85% of clinical trials fail to retain enough patients.1 The causes may lie in the low levels of knowledge about clinical trials. A recent survey found that only 19% of the public felt very informed about clinical trials.2 The actions of Inspire’s 1.3 million members reflect this uncertainty.  Searching Inspire for “clinical trials” yields over 50,000 unique discussions. “Looking for clinical [...]

Finding Patients With Rare Cancers Quickly

Finding Patients with Rare Cancers Quickly Almost one-third of all cancer deaths are caused by rare cancers but rare cancers represent only between 23.4% and 27% of all cancer cases.1 Between 25 and 30 million Americans and around 30 million people in the European Union live with rare diseases.2 Rare cancers are classified under rare diseases and are defined by the EU Society of Medical Oncology as having an incidence of less than six occurring per 100,000 persons per year.3 The National Cancer Institutes define the incidence of rare cancers as 15 per 100,000 persons per year.4 [...]