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Project Pre

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This is my project presentation which I did when I was doing my PGD in CR.
The truth which came out through this project was unbelievable

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Project Pre

  1. 1. TO STUDY THE AWARENESS OF ADR REPORTING IN HEALTH PROFESSIONALS IN MUMBAI AND EFFECT OF SOCIAL NETWORKING ON ADR REPORTING TO STUDY THE AWARENESS OF ADR REPORTING IN HEALTH PROFESSIONALS IN MUMBAI AND EFFECT OF SOCIAL NETWORKING ON ADR REPORTING By: Aditi Kamble Clinical Research
  2. 2. Analysis: 24% 15% 60%
  3. 3. Social NetworkingSocial Networking A social network is a description of the social structure between individuals or organizations. It indicates the ways in which they are connected through various social familiarities ranging from casual acquaintance to close familiar bonds. A social network is a description of the social structure between individuals or organizations. It indicates the ways in which they are connected through various social familiarities ranging from casual acquaintance to close familiar bonds.
  4. 4. Features of social networkingFeatures of social networking USER PROFILEUSER PROFILE SENDINGSENDING MESSAGESMESSAGES SEARCH OTHER USERSSEARCH OTHER USERS ADR reporting HOW????
  5. 5. SHARE Patients’ sharing health data is what makes our communities special. Patients learn from each other through sharing of traditionally private data FIND Patients’ find other patients like them to learn what options are available for treatment. Patients then share information with their health care team LEARN Patients learn about treatment options and what to expect from each in our Treatment and Symptom databases
  6. 6. Launched in 2005 by James Haywood and Benjamin Haywood Communities for ALS:3500 MS:11,000 Parkinson’s Disease: 3000 HIV: 2000 Mood Disorder: 8000 Progressive supranuclear palsy Devis Disease Multiple system atrophy 1.PatientsLikeMe is a patient- centered community creating new knowledge derived from the real- world disease experiences of patients 2.Historical private online sharing 3.Improvement in life of patients by sharing new knowledge 4.Regenerate the revenue for Pharma company
  7. 7. "About 300-500 ADRs are reported annually, but more than 95 per cent of them are not drug related." Pfizer's Dr Mukherjee According to FDA- ADR database only 10% of SADR’s and 2-4% of ADR’s are captured HCPsreport AEs on a voluntary* basis to the appropriate source, most often the manufacturer. Patient experiences adverse event (AEs) Manufacturers** receive AEs from patients and HCPs, have mandatory reporting requirements to the FDA Patient HCPs Pharma HCPsreport AEs on a voluntary* basis to the appropriate source, most often the manufacturer.
  8. 8. Will FDA require pharma to collaborate with site on AE reporting? How will physicians react to patients reportingAEs? Patient experiences adverse event (AEs) Pharma HCPs Patient Helps patients submit treatment- related AEs directly to the FDA through their site.
  9. 9. “522 patients are still taking Clonazepam while 62 patients quit the treatment of Clonazepam” PatientsLikeMe 522 patients are taking because 85% of its efficacy 62 left because of 20% of side effects
  10. 10.  Helps into direct reporting to FDA  Medwatch AE Log in Patientslikeme Fill Medwatch Save as part of account and
  11. 11. Open questions….. Severity of ADR Bias Clinical impact Thoughts for Pharma companies…… More online communities: Design monitoring process for extraction of online ADR’s FDA : More stringent rules and regulation More evaluation for both HCP and Pharma
  12. 12. Appreciation from Media
  13. 13. When you're talking deaths in clinical trials, mistakes are not an option. It's just an area where we have to have absolute, foolproof reporting in place. Arthur L(eonard) Caplan THANK YOU

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