#KeepingPatientsFirst

Welcome to the #KeepingPatientsFirst Integrated Research Platform for Patients and Physicians!

#KeepingPatientsFirst is a unique real-world study that will help us better understand the COVID-19 illness, how people are affected by the virus, how the disease progresses, and how people respond to the treatments that are provided. Your participation in this easy-to-follow study will help doctors and researchers learn more about the novel Coronavirus and COVID-19 and will provide real-time information to physicians and patients with a goal to support effective treatment decisions, help identify important promising new treatments, and benefit patients with this illness. The #KeepingPatientsFirst research platform is powered by Microsoft Azure and is designed to provide critical and rapid access to pooled real-time evidence for physicians and patients describing: 

  • COVID-19’s ‘natural history’ – up-to-date information on the course the disease takes as it affects people
  • Reported effectiveness of multiple COVID-19 therapies being used today, and of new treatments as they emerge
  • Patients’ reported outcomes (with appropriate privacy limitations) as they progress through their illness and treatment

Thank you for your interest in this unique and important program – your time and input will make a difference in this pandemic!

To access #KeepingPatientsFirst, please visit the following links:

For Patients

For Physicians

 

Questions and Answers about #KeepingPatientsFirst:

What is the #KeepingPatientsFirst platform?
The #KeepingPatientsFirst platform is an integrated Real-World Evidence (RWE) research platform developed by Parexel, a leading clinical research organization (CRO), and powered by Microsoft cloud technology that allows for the collection and analysis of data directly from patients and healthcare professionals. The platform provides patients and physicians a single source for rapid access to pooled real-time data and analyses on the COVID-19 illness, and on multiple COVID-19 therapies in use. It is our goal that physicians will find this information informative and help them in developing individualized treatment decisions and accelerating the identification of promising therapies.   

What is the benefit of the platform?
The platform is designed to gather both patient and physician information on their experiences with COVID-19 and accelerate identification of promising therapies in the context of the COVID-19 pandemic where innovative approaches are required. Data will be appropriately key-coded and/or deidentified to address privacy concerns. These data will then be analyzed and surfaced for patients and physicians to view throughout the study, providing insights into the evolution of the illness and patient outcomes.  Researchers and scientists will also be able to access these data in efforts to gain information to help characterize the real-world patient disease journey - from awareness to testing to diagnosis to disease resolution. 

Who can use the platform? Is there a restriction on who can participate?
All eligible patients and physicians, regardless of COVID-19 condition, are invited to share data on the #KeepingPatientsFirst platform. Patients must be 18 years or older and residents of the U.S.. Physicians within the U.S. can use the platform should their patient develop COVID-19 illness and receive treatment.  Physicians entering data regarding their patients’ responses to given treatments will be important in helping researchers understand how best to treat COVID-19. There is no fee for patients or physicians to use the platform or receive the results. 

What is the process for getting involved in #KeepingPatientsFirst? 
Participants answer questions through an application (“WebApp”) accessed via a compatible and internet-connected mobile device/telephone, tablet, or computer. Once collected, the data are analyzed on the #KeepingPatientsFirst data platform. Upon enrollment, patients will be asked to complete weekly 10-minute surveys for eight weeks; physicians will complete a baseline and a closure survey for each patient they are following in the platform.

What personal information is collected? 
Individuals will be asked to provide:

  • Personal contact details including first and last name, email address and mobile phone number
  • Demographic information related to age and race 
  • Coronavirus test dates and results (if any) 
  • Brief medical history
  • Medications (if any) taken for the treatment of COVID-19 or other relevant conditions
  • Any hospitalization for the treatment of COVID-19, and details related to the hospitalization
  • Details related to the course of illness, including symptoms, treatments, and outcomes
  • Participation in a COVID-19 clinical trial
  • Patient outcomes at the end of their hospitalization/COVID-19 illness

How are patient data being stored and protected? 
The protection and privacy of patient data is our top priority. Received data will be encrypted and then de-identified or key-coded to protect patient privacy according to applicable laws and regulations. Contact information such as a participant’s name, email address, and mobile number will be used only for communication about the study and will not be shared outside of those personnel engaged by Parexel for this study. All contact information will be stored separately from demographic, geographic, and healthcare information. Demographic, geographic and healthcare information will be held in a key-coded or pseudonymized format and will only be used for analysis of this and other approved research studies. 

Who is funding this study?
Parexel International Corporation, an independent Clinical Research Organization, is funding this study.

How do I remove myself from the study?
A participant may withdraw consent at any time by emailing their request to covid19patient@parexel.com. A request to withdraw consent from the study at any time, or a decision not to agree, will not affect any decision a patient’s physician chooses to make regarding the medical care the patient receives.

As a physician, how can I learn about broader results and trends reported in the platform?
Physicians will have access through the study WebApp to study data and insights, throughout the study, that Parexel makes available to enrolled physicians. Participating physicians may also submit analytic and publication concepts to the study for review and consideration. If approved by Parexel, these analyses can be carried forward by Parexel to develop further insights and findings from this important study.

Who can see the data I enter? 
All study data entered by participants will be tokenized and included in the aggregated data pool for analysis. The tokenization method assigns a unique code (a “token”) to a participant’s data to obscure that person’s personal information in a given data set, and then uses that token to combine those data with data from other datasets that have been similarly tokenized. Your individual data will not be visible or accessible to any third party (other than your physician, as applicable). 

Who should I contact if I have questions?
Any questions about the study, the rights as a participant, or complaints about the study may be emailed to covid19patient@parexel.com or covid19physician@parexel.com. Please do not put sensitive medical or personal information into that email.

We are always available for a conversation.

*