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Oncology clinical trials regulations & benefits

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A brief awareness presentation about Oncology Clinical Trials and how the current regulatory scenario is affecting it. The oncology patients are the greatest losers.

A brief awareness presentation about Oncology Clinical Trials and how the current regulatory scenario is affecting it. The oncology patients are the greatest losers.

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  • 1. 1 Oncology Clinical Trials- Regulations & Benefits Dr.Harsha Doddihal Associate Medical Director Quintiles Disclaimer: The views expressed here are in personal capacity and do not represent that of Quintiles.
  • 2. 2 Objective • Understanding Regulatory Scenario in India • How this affects Oncology community and patients • Brief Mention about Oncology Phase 1 and 2 trials • Remarkable Story! • Disclosure: Apart from being an Oncophysician, I also work as Associate Medical Director at Quintiles an have the responsibility of working with pharmaceutical companies, advising them on clinical research.
  • 3. 3 Need For Regulations • Moral & Ethical Challenges International: 1. Nuremberg Code 2. Tuskegee Syphilis Experiments 3. Beecher Article in NEJM 1966 4. Belmont Report 5. ICH-GCP 1990 http://www.hhs.gov/ohrp/archive/documents/BeecherArticle.pdf http://www.wemos.nl/files/Documenten%20Informatief/Bestanden%20voor%20'Medicijnen'/examples_of_unethical_trials_feb_2008.pdf http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121689/ National: 1. Letrozole Trial For Ovulation-2004 2. Streptokinase Trial-2003, 8 deaths 3. John Hopkins Scientist & RCC Trivandrum-26 oral cancer pts 4. HPV Vaccine Trial-Khammam district 5. Indore Story Image Courtesy http://crfocus.wordpress.com/tag/clinical-trials/
  • 4. 4
  • 5. 5 Regulations Today • In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required. • Financial compensation above that of medical management • Failure of investigational product to provide intended therapeutic effect will be considered as trial related injury. • Injury or death resulting due to placebo in a placebo controlled trial will be considered as trial related and will require compensation. • Adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; • Drugs and Cosmetics (First Amendment) Rules, 2013
  • 6. 6 Impact On Oncology 39,767 studies listed on clinical trial site of US 526 studies listed on clinical trial site of India No trials approved this year!
  • 7. 7 Why Does It Matter? • Patients are the greatest sufferers, being denied the chance, hope of research therapy and paving way for future • Personalized medicine demands need for local trials. Era of extrapolating data will gradually change • Lack of bio banks and local epidemiology, pathology data • Academic studies have come to a halt • Students facing problem in doing thesis • WHO, NIH funded trials have been withdrawn or stalled • MNCs and Indian companies are doing trials in other countries
  • 8. 8 Phase 1 and Phase 2 in Oncology • Phase 1 trials in Oncology are done in patients suffering from malignancy. In other therapeutic areas phase 1 is done on healthy volunteers. • Phase 2 Oncology trials can be randomized and accelerated to provide both safety, efficacy results. • Personalized Medicine requires more innovative thinking. We need better trial designs, adaptive trials etc.
  • 9. 9 An Inspiring Story • An example…. At age 44 (1992) diagnosed of CML- Started on Hydroxyurea- only short duration response She received Busulphan-Not effective Started on Interferon-alpha while being considered for Bone Marrow 1994- For Autologous BMT Stem cells were harvested at St Vincents Australia With Interferon she did well and was on it from 1994 to 2000 2000- Decided to participate in Imatinib trial at Singapore She went into accelerated phase on Imatinib in 2002 and received 3 cycles of chemotherapy and received Imatinib again 2005- The resistance to Imatinib was full blown and she was found to have T315I mutation. She also developed Parkinson in 2005 She did not fit for the Nilotinib trial in 2005 MK0457 a pahse1/2 trial for T315I mutation, they could not participate because of logistic reasons Imatinib dose increase did not help and she was put back on interferon, after 9 months she deteriorated New trial of inject able drug called Omacetaxine- side effects of losing teeth, skin- the intensity decreased For 2 years she was on Omacetaxine before moving to a new trail involving Ponatinib She is doing well on Ponatinib
  • 10. 10 An Inspiring Story • An example…. At age 44 (1992) diagnosed of CML- Started on Hydroxyurea- only short duration response She received Busulphan-Not effective Started on Interferon-alpha while being considered for Bone Marrow 1994- For Autologous BMT Stem cells were harvested at St Vincents Australia With Interferon she did well and was on it from 1994 to 2000 2000- Decided to participate in Imatinib trial at Singapore She went into accelerated phase on Imatinib in 2002 and received 3 cycles of chemotherapy and received Imatinib again 2005- The resistance to Imatinib was full blown and she was found to have T315I mutation. She also developed Parkinson in 2005 She did not fit for the Nilotinib trial in 2005 MK0457 a pahse1/2 trial for T315I mutation, they could not participate because of logistic reasons Imatinib dose increase did not help and she was put back on interferon, after 9 months she deteriorated New trial of inject able drug called Omacetaxine- side effects of losing teeth, skin- the intensity decreased For 2 years she was on Omacetaxine before moving to a new trial involving Ponatinib She is doing well on Ponatinib
  • 11. 11 • What can you do about it? > Being aware helps patients, physician and society! > Ignorance harms. Being aware of ethical concerns empowers and enhances. Allows one to ensure adherence of guidelines and SOPs > CDSCO invites people to comment on new rules and regulations!! We need to log on to their site and provide our comments. > Currently comments are being accepted for taking informed consent under video. Thank You!! Questions???? Curates Egg………Something good, something bad…….

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