Collaborative Clinical Research for Better Patient Outcomes Theme of 11th Annual Conference

Bangalore, January 18, 2018: Collaborative Clinical Research for Better Patient Outcomes is the theme of the 11th Annual Conference of the Indian Society for Clinical Research (ISCR) being held in Bangalore on the 19th and 20th of January, 2018. The two-day event, preceded by pre-conference workshops, will see over 800 clinical research professionals from across India and other countries deliberate on the collaborative role of clinical research stakeholders in a strengthened and improved clinical research regulatory environment.

“Thechallenges of the last few years set back the progress of clinical research inIndia which has impacted patients the most as it has delayed their access tonewer and more advanced treatment,” said Dr. Chirag Trivedi, President, ISCR“Withmore balanced and rational regulations in place, it is important for allstakeholders of clinical research to now discuss and evolve strategies to growthe clinical research environment in the country, while ensuring patient safetyas well as high quality clinical research for better patient outcomes.” Withthe second highest population in the world and a large disease burden (at 20%),less than 1.4% of global clinical research happens in India. “We needto make newer and better treatment options available locally and to patientsglobally. For this, India must proactively participate in conducting clinicalresearch (“Research in and for India”) and assume a leadership role globally sothat we can offer newer treatment options for our patients in India and acrossthe world (“Made for the World”),” added Dr. Trivedi.

 “The11th Annual Conference is being held at a very critical timefor the Indian clinical research industry,” said Dr. RameshJagannathan, Chair, Organising Committee, 11th ISCR Conference.“We have a significant task ahead of us in terms of not just strengthening theoverall infrastructure for and governance of clinical research in the country,but also in empowering patients who are at the core of any clinical researchactivity. Patients First is an important ethos of ISCR and our11th Annual Conference is also a renewal of our pledge to quality, patientsafety and data integrity.” Preceding the Conference are two days ofworkshops on various aspects of clinical research including evidence basedmedicine, pharmacovigilance, risk-based monitoring, clinical pharmacology andcareers in clinical research.

The2017 “India: Health of the Nation's States — The IndiaState-Level Disease Burden Initiative”  report statesthat  the contribution of most major non-communicable disease categoriesto the total disease burden has increased in all Indian states since 1990.These include cardiovascular diseases, diabetes, chronic respiratory diseases,mental health and neurological disorders, musculoskeletal disorders, cancers,and chronic kidney disease. Diarrhoeal diseases, lower respiratory infections,iron-deficiency anaemia, neonatal disorders, and tuberculosis continue to bemajor public health problems in many poorer states of North India.“Clinicalresearch is essential not only for developing medicines for emerging healthconcerns (such as antibiotic resistant pathogens, H1N1, Ebola virus,etc.)  but also for entrenched, tropical diseases (such as diseases suchas malaria, leishmaniasis, etc.) and lifestyle diseases such as diabetes andhypertension. Given our large unmet health needs and limited resources, we needto make newer and better treatment options available to our population in aquick, economical and dependable manner,” said Dr. DenisXavier, Chair Scientific Committee, 11th National Conference and Vice Dean, StJohn’s Medical College.

With theoverarching theme of “Collaborative Clinical Research for better PatientOutcomes”, the topics for the Conference have been deliberately chosen tobe of relevance to sponsor, academia and investigator-initiated research andcover various aspects of clinical research conduct involving multiplestakeholders. Given India’s potential to emerge as a big player in data-drivenclinical research services, two Conference tracks have been planned focusing onClinical Operations as well as Clinical Data Management/Biostatistics/MedicalWriting.

“Thegreat advances in medicine that have occurred over the last 60 years havelargely been the result of clinical research,” said Dr. Prem Pais,Former Dean, St John’s Medical College and an Investigator in severalstudies. “Clinical research has not only identified new and effectivetreatments but has also identified harmful treatments that has saved manylives. As an example, 60 years ago 30 per cent of people who suffered a heartattack died in the first month. Today about 8 per cent do.” Dr. Paisspoke of the need to create more awareness about clinical research so thatpatients are aware of their rights and the value that clinical trials canoffer.

Dr. Trivedisaid that it was imperative that the new and improved regulatory environment inIndia was communicated to the world at large so that more clinical research isconducted in India. A conducive clinical research ecosystem will encourage moreresearch and development and will give an impetus to the Government of India’s‘Make in India’ initiative. “As compared to 2016, close to a two and ahalf to three-fold increase has been observed in the number of global clinicaltrials approved by the DCGI in 2017 which indicates that the recent regulatorychanges have had a positive impact but we still need to do more,” hesaid. He spoke of two major challenges that need to be addressed – the proposedmandatory accreditation of Ethics Committees which if implemented from January2018 could cause huge operational challenges since majority of the EthicsCommittees have not yet applied form accreditation and the need to continueadvocacy efforts to create more awareness amongst various importantstakeholders about the good that clinical research has done for our Indianpatients in fighting their unmet medical needs. “We are as committed tothe DCGI’s commitment to making safe, efficacious, affordable and qualitymedicinal products for our people,” concluded Dr. Trivedi.

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