Patient Advisory Committee for Clinical Trials (PACCT) +

PACCT+ is a two year demonstration project to develop and test a program to train patients in basic clinical and health services research concepts, with the goal of enabling them to serve on a council to evaluate research proposals.

PACCT+ is available to researchers in academia and industry. A panel of 15-20 trained patients and caregivers are ready to provide researchers with non-binding recommendations, demonstrating inclusion of meaningful patient input in design and implementation of clinical and health services research.

Sharing this experience to benefit study design required patients to become familiar with clinical science research, in order to be in a position to offer meaningful feedback related to the impact of a study.

Good for Patients - 

Patients with rare bone marrow failure diseases such as myelodysplastic syndromes (MDS), aplastic anemia and paroxysmal nocturnal hemoglobinuria (PNH), are eager to propel research towards mitigation or elimination of their disease(s).

As ‘experts’ on the impact of and quality of life bone marrow failure, patients can provide early and meaningful input to guide the development of protocol for clinical studies in these rare diseases.

Good for Researchers - 

Patient feedback early in a study’s design, can contribute valuable insight into the patient experience in clinical trials.

Attention to this authentic patient participation and input can aid researchers in eliminating perceived and real barriers to patient recruitment and retention in clinical trials.

In collaboration with industry and clinical researchers, PACCT+ offers an opportunity to shape research with recommendations from actual patients and caregivers.

Involving patients early in the research process vocalizes the patient experience to develop patient centered studies that increase recruitment and retention, and ultimately improve outcomes.

Timeline - 

  • October 2015 – AAMDSIF receives a funding award from PCORI for this project
  • December 2015 – AAMDSIF held the first ‘PACCT+ management team meeting that included patients, academia and industry representatives along with staff. This group has guided development of the project so far with monthly meetings.
  • April 2016 - The first project report was submitted to PCORI
  • June 2016 – Patient recruitment publicity went out to select up to 20 patients and caregivers from the aplastic anemia, MDS and PNH communities to participate.
  • September 24th, 2016 - Selected participants attended the in-person training to learn about clinical trial research processes.

What’s next?

  • View the archived version of the PACCT+ Seminar training. Phillip Page, PhD. presents the basics of clinical research, and Leslie Pettiford, RN. MS.harm, CCRC discusses clinical research in bone marrow failure.
  • Outreach to academic and pharmaceutical researchers who could benefit from patient insight into the early stages of proposal development in clinical and health services research.
  • Designing an interactive process for proposal review, and collaboration between patient reviewers and researchers.
  • Offering a second round of training in 2017, based on feedback from the first session.

Want more information?

Contact Matthew Lesser, Program Support Specialist at lesser@aamds.org or Ellen Salkeld, Senior Director of Research at salkeld@aamds.org.