Study of practices for obtaining assent of pediatric patients in clinical trials just published

The Institute for Pediatric Innovation (IPI) announces that the Journal of Therapeutic Innovation & Regulatory Science has just published the results of a study on practices for obtaining the assent of pediatric patients who are asked to participate in clinical trials.

This study, entitled “Industry and Patient Perspectives on Child Participation in Clinical Trials,” is a result of a collaboration among IPI, biopharmaceutical companies Pfizer and Shire and healthcare communications firm The Medicine Group. Coauthors on the study are Irmgard Eichler, Stephanie Gilstein, Donald Lombardi, Philip Sjostedt, Liza Squires, Charles Thompson and Mark Turner.

The issue of obtaining assent of pediatric patients has long been seen as a challenge in the medical world, especially since the introduction of new regulations in the early 2000s. Although children cannot generally provide legal informed consent until they reach adulthood, they need to be given age-appropriate information and asked to agree to participate in clinical trials.

The study focused on determining how varying stakeholders dealt with ambiguities inherent in the assent requirements and the differences observed among patients from a range of ages and populations, cultures, clinical trial types and regulatory environments.

Launched in 2014, the study centered around digital surveys offered both in the United States and internationally. The first survey polled children, parents and/or caregivers while the second was aimed at clinical trial professionals on their organizations’ experiences and policies regarding pediatric assent.

Forty-five respondents completed the child and parent/caregiver survey. Fifty-seven individuals completed the industry survey. Survey respondents offered their experiences of clinical trials and challenges they encountered to secure assent. Common obstacles included language barriers, cultural issues, disease severity and child maturity.

Respondents also surfaced potential solutions. Both children and parents/caregivers called for visual aids that would clearly explain the procedure while retaining a child’s attention. The study reports that standardized practices and tools would help pediatric patients make well-informed decisions about their participation in clinical trials. Such tools would establish a baseline standard for the assent process.

The results of the surveys indicate that a shift in handling management of child assent can provide relief for parents and children in a hospital setting.

If you are interested in reading the article, visit the online journal.

Participants in IPI’s Catalyst Program Develop Solutions for Unplanned Extubations in Babies and Children

2017 Participants at Shriners Hospitals for Children

2017 Participants at Shriners Hospitals for Children

This year, participants in the Institute for Pediatric Innovation’s (IPI) Clinical Innovation Catalyst program focused on finding product improvements that could reduce the occurrence of unplanned extubations (UEs).

Pediatric patients have tubes placed in their throats when they need help breathing or to provide medication. Sometimes, patient movement can cause unplanned UEs which is when these tubes become dislodged or removed, resulting in situations that can prolong treatment or even become life threatening. In addition to additional treatment time and potential airway trauma, these conditions can add an average of 6.5 days to a hospital stay and up to $37,000 per case in pediatrics.

IPI’s Catalyst program, a professional education experience and training program for nurses and allied health professionals, addresses hospital acquired conditions to improve safety and outcome. Innovation concepts are developed based upon these clinicians’ vast experience, education, practice and input from patients, families and other caregivers to generate new devices and technology for pediatric hospitals. Each year, IPI’s member hospitals choose a new hospital acquired condition on which to focus.

Selected participants from member hospitals— Shriners Hospital for Children Northern California, Stanford Children’s Health, Texas Children’s Hospital and University Hospitals Rainbow Babies & Children’s Hospital—participate in four workshops each focused on a different aspect of the innovation process. Workshop topics include problem identification, content development, concept refinement/selection and business planning. At the conclusion of the four workshops, participants deliver fully developed product concepts.

During this year’s cycle, the team of three respiratory therapists, two nurses and one parent developed three product concepts: ShapeTape, HoldET and Flo-Frame to reduce the outcome of UEs.  

The first product concept presented was ShapeTape, a precut therapeutic kinesiology tape used to stabilize the ET tube. This durable tape, adapted from other healthcare uses, is specially precut to adapt to a baby’s face and withstands patient movement and adverse environments. Participants assessed the business opportunity, noting its lower cost against competitors and potential to decrease UEs by 20%.

HoldET reinvents an existing ETT holder by adding adjustable straps to securely fit pediatric patients. The product will decrease UEs by an estimated 10%.

The final product concept, Flo-Frame, included improved fixation of the tubes to the patients, a re-invention of current tube holder design, and system to more easily move with the patient. It is estimated that the device will decrease UEs by as much as 10%.  

IPI is currently seeking commercialization partners to continue ongoing product development and commercialization of these concepts.

 “This program enables bedside providers to make smart, significant and most of all, useful changes to well-known healthcare problems,” said Catalyst participant Jennifer Michals.

The final product concepts highlight participant dedication to finding effective solutions to the many challenges encountered in pediatric hospitals.


IPI Awarded Grant for New Alcohol Wipe Development

Catalyst participants visit Shriners Hospital for Children - Northern California.

Catalyst participants visit Shriners Hospital for Children - Northern California.

Huge thank you to the New England Pediatric Device Consortium for awarding IPI a grant to develop a new alcohol wipe. Participants from our four consortium hospitals designed four products in last year's Catalyst Program.

The 2015-2016 catalyst program cycle focused on the reduction of central line-associated bloodstream infections (CLABSIs) in pediatric hospital settings. These occur when a patient develops a bloodstream infection after receiving a catheter, or central line, run through a vein into the vena cava. CLABSIs are among the most common hospital-acquired conditions and cost hospitals billions of dollars each year.

For more information, check out our press release on PRWeb.

Executive Assistant Position Available!

Would you like to support the mission and vision of IPI? We have a job opening for an executive assistant/office manager at our Boston office, and we're hoping to fill it as soon as possible!

The position will report directly to our president and CEO, and will provide administrative and clerical support to keep the office running smoothly. Specific job functions include:

  • Providing administrative support for management staff, including communications with the Board and partner committees, correspondence and mailings, and coordinating travel arrangements;
  • Coordinating and scheduling weekly and monthly meetings;
  • Maintaining Board of Governors records and preparing for Board meetings, including scheduling, booking conference rooms, preparing agenda, and recording minutes;
  • Managing and maintaining timelines and files for all operations projects, contracts, grants, intellectual property, etc. in accordance with HIPPA regulations;
  • Preparing correspondence and mailings for executive staff, such as for fundraisers, to donors, or to IPI stakeholders;
  • Coordinating administrative responsibilities associated with fundraising events; and
  • Other responsibilities as required

Candidates should possess the following skills:

  • Strong written and verbal English communication skills required; English fluency preferred
  • Strong editing skills, with attention to detail and the ability to meet deadlines
  • Knowledge and familiarity with fundraising research techniques
  • Familiarity with database management and social media; website design preferred
  • Fluency with Microsoft Office Suite, especially Excel, PowerPoint, and Word

Qualifications for this position include:

  • Bachelor's degree required; preferred in English, Public Health, Journalism, or Technical Writing
  • Experience working in deadline-driven environments
  • Ability to work well as part of team, to handle multiple assignments at once, and to meet deadlines
  • Ability to self-manage workload
  • Previous experience with non-profit fundraising preferred

This position is full time and FLSA exempt. Hours will be Monday-Friday, 8:30 am - 4:30 pm.

If this sounds like you, send your resume and CV along with a cover letter to Gail Campbell at

Challenge Produces Innovative Pediatric Medication Dispensing Devices

IPI recently partnered with Pfizer to hold an open innovation challenge to solicit and support innovative ideas to administer a new drug formulation. Pfizer has developed a solid multiparticulate drug formulated specifically for children.

Twenty-five applicants submitted designs for the challenge. In the end, two companies were chosen as winners, with grants from Pfizer of $50,000 each. One company was Balda C. Brewer, of the Balda Group, who has extensive experience in creating plastic solutions for the healthcare industry. The other was HS Design, a recognized leader in user-centered medical design.

We look forward to continued collaboration with both companies on developing their designs into useable products. For more information, see our press release at