Updates

1
Updates

• Johanna Piper,
• Research Governance GCP Manager.
• Barts the London NHS Trust
• 7th July 2005

2
First International Clinical Trials Day

• May 20th now International Clinical Trials Day.
• Date agreed at European Clinical Research
  Infrastructures Network (ECRIN www.ecrin.org).
• Date will be an international focal point for
  communication events meetings from 2006.
• Aim to focus attention on importance of clinical
  research, foster discussion and debate.
• Increase awareness amongst patients and public
  regarding methods / challenges of clinical
  research

3
Why May 20th?

• May 20th - date in 1747 when James Lind started
  the first ever clinical trial into scurvy
  treatment.
• Scottish naval physician, James Lind was on board
  a ship, the Salisbury and compared six treatments
  for scurvy in twelve patients.
• Patients had similar symptoms, lived in same room
  and shared the same meals.
• Patients divided into six groups (2 patients in
  each) and gave each group a different
  treatment.

4
The first ever clinical trial?

• Groups received the following treatments -
• Group 1 Cider
• Group 2 Elixir vitriol
• Group 3 Vinegar
• Group 4 Sea water
• Group 5 Spices/garlic/mustard seed mixture
• Group 6 Oranges and lemons
• After 6 days, one patient in group 6 was fit
  enough for duty, the other was well enough to be
  appointed as a nurse to other patients.

5
The first ever clinical trial?

• Lind reported this experiment in 1753 in the The
  treatise of the scurvy.
• Realised the efficacy of oranges and lemons in
  treatment of scurvy, although until vitamins were
  discovered, the actual effects were understood.
• Lind established foundations of evidence-based
  medicine, now a cornerstone of health research.
• Lind designed first comparative trial as at the
  time mostly observational/experimental methods
  used.

6
Survey assessing the impact of the Clinical
Trial Regulations(2004) on non-commercial
trialsMRC Clinical Trials UnitMay 2005
7
MRC Clinical Trials Unit Survey

• Survey of trialists and trial managers involved
  in non-commercial trials in the UK
  questionnaire.
• UK Trial Managers Network, UK Clinical Trials
  Forum, National Cancer Research Network (NCRN)
  were groups involved.
• 96 responses, described main problems had
  encountered with Clinical Trials Regulations.
• Issues around increased paperwork and delays to
  getting trials started.

8
Main problems encountered

• Sponsorship 60 reported this as problematic.
• Trust RD approval 46
• MHRA approval 42
• Ethics committee approval 32
• Pharmacovigilance 27
• Sponsorship
• Difficulties identifying and securing
• sponsorship, delays in written confirmation.
• Some Universities / Trusts unwilling to take on
  sponsorship role, hard to agree in some cases.

9
Main problems encountered

• Identification of sponsor delays starting
  trials.
• Delays in sponsorship agreements being written.
• MHRA
• Delays getting approval DDX/CTA rollover
• Lack of response, inconsistent answers !
• Ethics Committee approval
• Most problems with introduction of new form.
• Confusion around protocol amendments.
• Issues with Site Specific assessments and
  communication between MREC LRECs.

10
Main problems encountered

• NHS Trust RD approval
• Delays giving approval paperwork variations
• Honorary contracts inconsistencies in advice
• Pharmacovigilance
• Problems reporting, unsure of mechanisms
• Concerns regarding academic sponsors reporting
• Other issues international trials
• Sponsorship in other member states, single
  sponsor?
• Insurance / indemnity issues differ outside EU

11
Summary

• Expressed concerns regarding lack of clear
  guidance and mis-interpretation of Regulations.
• Concerns regarding impact on small scale studies
  and trials on rare conditions extra paperwork.
• Survey - done in first 6 months of
  implementation.
• Introduction of the Clinical Trials Toolkit
• (www.ct-toolkit.ac.uk) and further guidance
  introduced should have made a difference.