Insight

Initiatives on Global Clinical Trials

  • 7th September, 2016
GCT, CDSCO, RCGM, DCGI, GCP, India, CliniExperts, Form 44, Form 12, CTRI, Ethics committee

 

India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India.

To utilize its full potential with respect to the trained GCP professionals, trained investigators as well as infrastructure, Indian Government has undertaken few positive initiatives, which has relaxed the norms and regulations of conducting Clinical Trial in India which we shall discuss below in this article. The initiatives taken by Indian Regulatory Agencies might make India a favourable destination for conducting good clinical trials and help in creating a favourable environment for the pharmaceutical sector to advance.

 

 

New Initiatives Taken by CDSCO:

  1. Number of Trials performed by the Investigator
    • Initially, Investigators were not allowed to conduct more than three clinical trials at any given period of time
    • New amendment has removed the capping limit
    • Thus, an investigator can carry out more than three clinical trials, but first risk and complexities will be examined by the Ethics Committee

 

  1. Requirement of beds in Hospitals
    • Initially, trials have to be carried out at a Hospital having 50 or more than 50 beds
    • New amendment has removed this restriction
    • It means that, any trial can be carried out at any hospital (not necessarily having at least 50 beds), but these hospitals must have all emergency care facilities required for carrying out the trial
    • Thus, the Ethics Committee will take a final call with regard to whether the hospital is suitable for a particular clinical trial or not, irrespective of the number of beds

 

  1. Addition of a new clinical site or Investigator
    • Initially, it was mandatory to submit a “No Objection Certificate” of higher authority (DCGI) for adding a new hospital as a new trial site or for adding a new investigator
    • The new amendment has altered this requirement
    • Now, it is not necessary to provide such a No Objection Certificate, but compulsory to inform and take an approval of the Ethics Committee is sufficient (regarding adding a new hospital as a site of clinical trial or adding a new investigator)
    • While it is approved, the proposal of addition of a new hospital or investigator has to be notified to DCGI; if DCGI does not raise any objection, the proposal is approved

 

  1. Parallel submission of applications in RCGM and CDSCO for their Approval
    • A new rule, regarding drugs prepared from r-DNA (re-combinant DNA technique), for example Insulin, Monoclonal antibodies, etc., are to be first approved by the supreme authority, i.e., RCGM
    • After the approval of RCGM, another authority DCG(I) can grant permission for conducting the trial
    • However, an applicant can apply for both these places simultaneously, so that the procedure of approval is relatively faster

 

 

Huge patient database and trained GCP professionals makes India an outreach.

 

Benefits of Conducting Clinical Trials in India

  • Large patient pool with diverse ethnicity
  • Extensive network of laboratories and hospitals
  • Low operational cost as well as low per-patient trial cost
  • High quality medical expertise and care at low costs
  • Enables large scale trials due to high population density
  • Easy policies and approval processes

 

 

Global Clinical Trial Definition:

Global clinical trials are large scale trials conducted across populations from multiple countries to enable high quality, unbiased outcomes.

 

 

Documents Required To Be Submitted To Conduct A Global Clinical Trial

  • Clinical Trial Application letter
  • DCGI Approval letter
  • Authorization Letter from Sponsor
  • Form 44 and Form 12
  • Product Details
  • Study Protocol- Phase of Study
  • Investigator undertaking
  • Patient Information Sheet/ Informed consent form
  • Undertaking by the Sponsor
  • Justification for conducting the study in India
  • Export NOC for biological samples
  • List of investigators
  • Ethics Committee approval and notification to CDSCO
  • Investigator’s brochure
  • Undertaking by sponsor for marketing authorization in India
  • Pre-Clinical and Clinical data
  • Pre-Clinical data
  • Animal Pharmacological Data

 

 

Some of the crucial steps in Conducting a Clinical Trial

  1. Registration of the trial with CTRI
  2. Taking approval from DCGI and Ethics committee
  3. Public declaration and identification of

– Investigator

– Sponsors

– Interventions

– Patient population

– Trial size and Target sample size

– Date of enrolment

  1. Conducting the clinical trial
  2. Recording the trial results

– Documenting results

– Audio-visual recording

  1. Reporting the trial-data to CTRI (Reporting of data under following categories)

– Positive outcomes

– Unfavourable outcomes

– Adverse events

  1. Publication of the trial data

 

 

Challenges faced in India for conducting Clinical Trials

  • Increased reported clinical mishaps
  • Negative media coverage
  • Protests by activists
  • Stagnant regulatory process
  • Limited number of qualified Investigators
  • Limited number of clinical trial centres, hospitals, and investigation laboratories
  • Lack of enforced regulations and limit approvals to regulators are discouraging investigators and sponsors from conducting clinical trials

 

 

Impact of Challenges

  • Sponsors are shying away from conducting clinical trials in India
  • International companies (multinational companies) are turning away
  • Indian developers are conducting clinical trials in other countries for drugs made in India

 

 

Mission and Vision of New Initiatives

  • To improve transparency and accountability of Clinical trials
  • To improve the quality of clinical trials
  • To conform the accepted ethical standards
  • To report all relevant results of the registered trials

 

 

 Summary of New Initiatives taken by CDSCO

  • To make India a favourable destination for conducting good clinical trials
  • To create a helpful and active environment for the Pharmaceutical sector for developing new drugs for fighting against prevalent and emerging diseases
  • To make a clinical trial hassle-free
  • To make the entire procedure streamlined and faster
  • To provide patients with safe, efficacious, and high quality medical products at relatively affordable prices

 

 

Abbreviations

  • CDSCO – Central Drugs Standard Control Organisation
  • DCGI – Drug Controller General of India
  • RCGM – Review Committee of Genetic Manipulation
  • CTRI – Clinical Trial Registry – India

 

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