{Reference Type}: Journal Article
{Title}: Emphasizing Patient-Centricity Through a Tailored Training Program to Empower Patients, Advocates, and Ethics Committees in Good Clinical Practice.
{Author}: Bagai P;Sharma P;Ansari A;Singh N;Sharma S;Singh P;Chougule D;Singh MK;Singh G;Singh S;
{Journal}: Cureus
{Volume}: 16
{Issue}: 7
{Year}: 2024 Jul
暂无{DOI}: 10.7759/cureus.64042
{Abstract}: <B>OBJECTIVE: </B>Good Clinical Practices (GCP) are essential for patient-centric research. The standard bioethics and GCP training emphasizing a "one-size-fits-all" approach may not adequately equip ethics committee members, especially the lay and social scientist members, towards their critical role in reviewing clinical trials and related documentation. This article explores a patient-centered, patient advocates-driven training program focused on raising awareness about research ethics and GCP among patients, advocates and ethics committee members.<BR><B>METHODS: </B>A patient advocates-driven program called Patient Advocates for Clinical Research (PACER) conducted trainings focused on GCP for patient-centric research for patients, advocates and ethics committee members. Pre- and post-workshop questionnaires were used to assess the participants' knowledge of GCP.<BR><B>RESULTS: </B>The workshop was attended by 116 participants. Of these 91 consented to participate in questionnaire evaluation that assessed participants' knowledge on ethics committee (EC) functionality, research ethics and data confidentiality. Pre-workshop evaluations highlighted knowledge gaps. Only 16.5% were familiar with the primary ethical consideration for vulnerable populations and 69.2% were knowledgeable about data governance. Post-workshop evaluations demonstrated significant overall response improvement of 5.4% (𝜒2=13.890; p<0.001). The understanding of ethical considerations for vulnerable populations rose by 15.4% (p=0.007), and knowledge of data privacy regulations improved by 11.0% (p=0.041).<BR><B>CONCLUSIONS: </B>The workshop under PACER initiative highlighted the knowledge gaps in understanding the EC functionality, research ethics and data confidentiality. The workshop effectively fostered participants' understanding of ethical research practices.