Social Media and Clinical Trials: Patient-Physician Interactions, Patient-Patient Interactions

Duration: 60 Minutes
This webinar will discuss the best practices, and do's and don'ts for using social media in clinical trials. Common issues, misconceptions, perceptions, and possible solutions will be discussed. Issues such as role of online patient communities in creating new information repositories, educational tools, information management, crisis management, public relations, and technological consistency will be discussed. Crowd-sourcing of creation, updating, selection, and management of clinical trial information will be discussed using examples for the presenter's extensive experience in the field. The webinar will provide tips and suggestions for addressing potential issues related to individual, institutional, and regulatory obstacles to using social media in the current research landscape.
Instructor: Mukesh Kumar
Product ID: 501107
Objectives of the Presentation
  • Best practices for using social media for patient-investigator interactions
  • Issues related to patient-patient interactions such as "Patientslikeme"
  • Common ways companies are currently using social media in clinical trials
  • FDA rules for using social media in clinical trials
  • Crowd-sourcing, Wiki-creating, data-mining, and other social media practices for clinical trials
  • Recent trends in FDA enforcement actions involving social media.
Why Should you Attend
Social media could be a great resource to clinical trials by highlighting specific issues, addressing concerns, educating patients and doctors alike, and engaging multiple other groups such as patient support groups, families, public policy makers, politicians, and general public. Social media can be a valuable tool to create awareness about a given trial, disease, patients, and developers. Social media is increasingly used to provide all information about the products being tested, the scientific background, and in general, educating all stakeholders. It makes it easy, accessible, timely and broadly available. While a lot of discussion has been conducted in using social media as a recruitment tool, the impact of social media goes much beyond recruitment of patients but goes into ongoing discussion between patients and investigators, investigators and sponsors, patients with other patients, and sponsor and patients.

This webinar will discuss numerous ways in which social media led patient-patient, patient-investigators, investigator-sponsor, and sponsor-patient interactions and data-mining can be conducted for a better, efficient and productive clinical trial. There are also concerns about maintaining trial integrity, logistical affability, and financial feasibility of using social media in clinical trials. FDA rules and industry practices will be discussed in light of the technological challenges with using social media in clinical trials.

Who can Benefit
  • Clinical Project Managers
  • Clinical Research Associates
  • Clinical Coordinators
  • Principle Investigators
  • Compliance Managers
  • Regulatory Vice Presidents, Directors and Managers
  • Attorneys - In-house or Outside Counsel
  • Senior executives of Pharmaceutical and Device Firms
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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