Un informe imprescindible: House of Commons – Access to clinical trial information and the stockpiling of Tamiflu – Public Accounts Committee

Access to clinical trial information and the stockpiling of Tamiflu

vía House of Commons – Access to clinical trial information and the stockpiling of Tamiflu – Public Accounts Committee.

Conclusions and recommendations
On clinical trials
1.  We were surprised and concerned to discover that information is routinely withheld from  doctors  and  researchers  about  the  methods  and  results  of  clinical  trials  on treatments  currently  prescribed  in  the  United  Kingdom.  This  problem  has  been noted for many years in the professional academic literature, with many promises given,  but  without  adequate  action  being  taken  by  government,  industry  or
professional bodies. This now presents a serious problem because the medicines in use  today  came  on  to  the  market—and  were  therefore  researched—over  the
preceding  decades.  None  of  the  latest  proposals  from  regulators  or  industry
adequately addresses the issue of access to the results of trials from previous years on the medicines in use today.
Recommendation:  The  Department  should  take  action  to  ensure  that  the  full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed, and should also ensure that there is clear and frequent audit of how much information is available and how much has been withheld.
2.  The  results  of  clinical  trials  on  humans  are  the  key  evidence  used  by  regulators, researchers  and  clinicians  to  assess  whether  a  medicine  works  and  how  safe  it  is.
Medicine manufacturers submit evidence on products they wish to market in the UK
to  the  Medicines  and  Healthcare  Products  Regulatory  Agency  (MHRA)  or  the
European Medicines Agency (EMA).
3.  The scope for independent scrutiny of a medicine’s effectiveness is undermined by the fact that the full methods and results of many clinical trials are not made available to doctors and researchers. The problem of non-publication of clinical trial results has been known since the mid-1980s. We also heard evidence that trials with positive results are about twice as likely to be published as trials with negative results. While several clinical trial registries have been established, none covers all clinical trials on all  uses  of  all  treatments  currently  being  prescribed  worldwide.  There  have  been recent announcements by the EMA, and some manufacturers, to improve access to information  about  clinical  trials  but  none  adequately  addresses  the  issue  of incomplete  disclosure  throughout  medicine.  Opening  up  information  about  all clinical  trials  to  medical  researchers  would  support  the  work  of  regulators  by permitting thorough, independent external review by doctors and researchers .
Recommendation:  The  Department  and  the  MHRA  should  ensure,  both
prospectively  and  retrospectively,  that  clinical  trials  are  registered  on  an
appropriate registry and that the full methods  and  results  of all trials should be
available  for  wider  independent  scrutiny,  beyond  the  work  undertaken  by
regulators during the licensing process.
4.  NICE  and  the  MHRA  do  not  routinely  share  information  provided  by
manufacturers during the process for licensing medicines. When applying for a
licence, manufacturers have a legal obligation to provide all the information on the
safety and efficacy of a medicine that is required by European regulators. However,
NICE does not have statutory powers to demand information from manufacturers,
in  contrast  to  the  Institute  for  Quality  and  Efficiency  in  Healthcare  in  Germany, which performs a similar role to NICE. NICE seeks confirmation from the medicine manufacturer’s UK medical director on the completeness of information, but this may not include all clinical trials in other parts of the world, not least because UK medical directors may themselves not have full information. The MHRA confirmed there  was  no  legal  obstacle  that  would  prevent  it  from  sharing  information  with NICE.  However,  there  is  no  routine  sharing  of  the  information  provided  by manufacturers to regulators as part of the licensing process with NICE. This leads to the risk of omissions and duplication in the collection of evidence.
Recommendation: NICE should ensure that it obtains full methods and results on all trials for all treatments which it reviews, including clinical study reports where necessary;  make  all  this  information  available  to  the  medical  and  academic community for independent scrutiny; and routinely audit the completeness of this information.  NICE  and  the  MHRA  should  put  in  place  a  formal  information-sharing agreement to ensure when NICE appraises medicines it has access to all of the information provided to regulators by the manufacturer during the licensing process.

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