Remove Red Tape

Medicines: Clinical Trials

These regulations affect anyone conducting a Clinical Trial in the UK. The purpose of these regulations is to protect the rights, safety and well being of participants in research and ensure that the results from research are both robust and credible.

The UK legislation is based on the European Clinical Trials Directive which aims to harmonise the regulation of clinical trials across the EU. The European Commission has consulted twice over the last two years on the impact of this directive and proposals to improve it. The plan is to publish the final proposals mid 2012.

However we still want to hear your views on what you would like to see to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections. You can find the regulations that relate to Clinical Trials to the left below.

Tell us what you think should happen to these regulations and why, being specific where possible:

• Should we scrap them altogether?
• Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
• Could they be reformed, simplified or merged? How?
• Can we reduce their bureaucracy through better implementation? How?
• Can we make their enforcement less burdensome? How?
• Should they be left as they are?

44 comments on “Medicines: Clinical Trials”

1. Elizabeth Hooper on April 12, 2012 at 3:13 pm said:

   GCP-RMA Response to the Red Tape Challenge

   On the matter of inspections

   There can be considerable duplication and overlap in inspections conducted by regulatory agencies. For some organisations, especially smaller ones, preparation for- and the hosting of- inspections can place a heavy burden on staffing, finances and resources. Many of regulatory agencies focus on common areas, including (but not limited to) staff CVs and training records, contracts and insurance. Pooling such information as well as inspection reports could be beneficial to both regulatory agencies and inspected organisations alike.

   To illustrate, a UK hospital pathology division might reasonably expect to be inspected by UKAS (for ISO15189/CPA compliance): The Human Tissue Authority (for compliance with the provisions laid down in the Human Tissue Act); the Care Quality Commission; the MHRA (under the Blood Directive); and the MHRA (under the Clinical Trials Directive). Although each inspection will concentrate on a specific area and pre-defined standards, each inspector will invariably review the same ‘quality systems’. If visits were closely scheduled there would be scope for accepting the outcome(s) of near previous audits so reducing the administrative burden and ensuring operational and financial efficiencies.

   In clinical research it is not uncommon for a study to be inspected as part of the contract research organisation’s routine GCP inspection and then inspected by the sponsor following a submission for a marketing licence. If a ‘mutual recognition’ procedure were established, information gathered during inspections could be shared by all relevant UK regulatory agencies inspecting aspects of the same quality system.

   On the matter of records retention

   The question of retention periods for clinical trial documentation can be both contradictory and confusing. There is an anomaly in which medicines legislation refers to specific retention times based on product liability (i.e. life of product) when the majority of other legislation relies on the Limitations Act to define retention periods. Clarification of retention periods based on a defined regulatory need will greatly facilitate sponsors’ determination, implementation and management of retention periods for documentation related to medicinal products.

   -text edited-Comment Tags: GCP-RMA
2. Jim Ballinger on April 12, 2012 at 12:26 pm said:

   The availability of QPs is a limitation for clinical trials in the NHS. In extremely specialised areas such as radiopharmaceuticals the MHRA should relax its interpretation of QP and accept qualified radiopharmaceutical scientists, though that is not yet a recognised title. I have been told that this is being done in some other EU countries.
3. Jim Ballinger on April 12, 2012 at 12:25 pm said:

   The definition what constitutes a clinical trial requiring an IMP must be clearer and applied more consistently. There are instances where the MHRA has given divergent opinions on the same project. Granted, the MHRA is trying to work with researchers, specifically in the area of PET radiopharmaceuticals, but obstacles remain. We are told it is all down to the wording of the research question, but first in human studies will always include basic safety and stating that as an objective automatically makes it a clinical trial rather than a mechanistic study.
4. Jim Ballinger on April 12, 2012 at 12:24 pm said:

   Radiopharmaceuticals should be exempt from the Clinical Trials Directive. Failing that, there should be a relaxation in the application of the CTD to radiopharmaceuticals in the UK. Firstly, there is a very low risk to the patient/volunteer involved in radiotracer studies. The radiotracer is normally administered in the microdose range, particularly for PET tracers. The whole raison d’etre for tracers is that they do not perturb the system they are studying. The subjects are studied with 1 or 2 sub-pharmacological doses delivered to normal volunteers or patients with known disease under medical supervision in hospitals with a known quantifiable risk from the radiation dosimetry. Secondly, most academic trials of radiopharmaceuticals are not being used as part of a drug registration process. This is important because much of the information that has currently to be supplied in a CTA is justified because this is ultimately used to support the final drug registration process.

   The current highly restrictive system is having a profound effect on academic trials across Europe but especially in the UK (Langstrom et al, EJNMMI). This is particularly evident in radiopharmaceuticals that have been used in one member state but not in another, requiring full justification for a clinical trial and an IMP process (e.g. Fluorocholine, C-11 choline, methionine, FLT etc).

   There is also a need for more biomarker studies using radiotracers (radiopharmaceuticals) to support developments in molecular targeted therapies. These developments are being slowed down and need a shortened application format to fast track agents that have no pharmaceutical activity.

   The application process for academic trials should be greatly reduced to provide a more limited but sufficient justification on the grounds of a) safety (pharmacological, toxicological, and radiological) and b) scientific robustness.

   There is a requirement for transparency and simplification of the process for IMP applications and it would be important to avoid duplication of effort and cost by identifying that an IMP has been approved for certain radiopharmaceuticals such that subsequent research groups would not have to repeat toxicology etc., thus reducing expense for public sector grant funding bodies.
5. Becky Purvis on April 12, 2012 at 10:58 am said:

   The Association of Medical Research Charities (AMRC) is a membership organisation of the leading medical and health research charities in the UK. Charities are part of the UK’s diverse funding landscape. In 2011-12, AMRC’s 124 medical research charities invested over £1 billion in health research . In the same year, over 3000 clinical studies were conducted in the NHS; 37% were funded by AMRC member charities. All our members are focused on benefiting patients and share a commitment to funding the highest quality research and many have a strong patient group allied to them.

   Charities have a strong mandate to ensure their investments deliver better healthcare for patients. Successful commercialisation of research to develop new therapies for patients is key to achieving this. We support measures to incentivise development and accelerate access to innovative drugs for those who need them. These developments must be patient-centred and maintain public confidence.

   We welcome the MHRA’s action to make the improvements recommended by the Academy of Medical Science in 2011 . We welcome steps towards a more proportionate approach to clinical trials regulation . It is vital that the MHRA continues to collect information on the number of studies that have required less bureaucratic assessment, and that continuing information and support is provided to all partners, to ensure that they are aware of this approach. Non-commercial sponsors have previously reported greater difficulty in navigating MHRA regulatory processes than commercial sponsors . The MHRA should involve representatives of smaller, non-commercial sponsors as new approaches and guidance are developed and consider tailored support and communication.

   Effective improvement of the EU regulatory structure depends on revision of the EU Clinical Trials Directive. The MHRA must continue to work closely with stakeholders across the medical research community to reach agreement on what the UK wishes to achieve from the Directive and effectively present this position at the EU level.

   We welcome the government’s announcement that the MHRA will consult on proposals for a new ‘Early Access Scheme’ to increase the speed and efficiency of routes to market approval for innovative, breakthrough therapies.

   Currently a large amount of data is required before a drug can be licensed to allow the majority of patients to gain access. Processes for the post-licensing evaluation of efficacy could be improved to promote the most effective use of treatments. This leads to delays for patients in receiving innovative therapies, slow responsiveness to emerging data on treatment efficacy and risks, and high costs for funders.
   Adaptive licensing models are being developed which may offer solutions, allowing earlier access for those who need it and a more iterative approach to information gathering on the benefits and risks of new therapies .

   We look forward to the proposals in the Early Access Scheme consultation and hope that they will go some way to address some of these issues.

   There are several areas of medicine development where the current regulatory structures pose challenges including:

   • Orphan conditions – classic drug trial designs including randomised control trials (RCTs) present a significant obstacle for rare disorders where it may be difficult or impossible to gather sufficient numbers of patients and generate the necessary levels of statistical significance. There are also difficulties in trialling drugs for conditions affecting children due to limitations of trials involving children and few adult participants to conduct sufficient research .
   • Biopharmaceuticals – increasingly drug development focuses on biopharmaceuticals. However with this comes an increased stratification of medicines as drugs are targeted to benefit smaller patient groups with specific variants of conditions. This brings difficulties in assembling sufficient patient populations for trials. This is exacerbated by the need for diagnostics to identify those that with variants of a condition that might benefit from the treatment. Without these diagnostics, trials may show lower than expected success rates as all variants – including those for whom the therapy will be ineffective – are enrolled introducing delays in an innovative treatment reaching those that may benefit from it.
   • Trials of regenerative medicine therapies – clinical trials of cell therapies pose unique challenges to classic drug trial designs. They have a high level of uncertainty as there are particular difficulties in predicting potency for cells which – unlike drugs – have the potential to multiply. Due to their specific targeting to conditions, they effectively focus on ultra-orphan conditions bringing difficulties in accessing suitable patient populations, as discussed above. This specificity also raises questions over the appropriateness of testing in animal models .
   A move to a more adaptive licensing model could address some of these challenges and prevent regulation from becoming a barrier to medical advances. This will require a strategic change to how we regulate; future regulation must have the flexibility to evolve to suit innovative technologies. We welcome the government’s plan to establish a group of experts ‘drawn from government, regulators, the NHS, industry, and the academic and third sector communities’ to discuss healthcare regulation issues including the development of new initiatives and innovations .
   The group should consider:

   • The acceptable risk-benefit balance – adaptive licensing models offer earlier access but place a greater emphasis on post-marketing evaluation of safety and effectiveness. In assessing the acceptable risk-benefit balance it is important that both patient views and ethical discussion of acceptable and proportionate risk are taken into account. More sensitive systems providing information on the risks and potential clinical benefits will need to be developed and an agreed format to model this to enable informed decisions and allow us to move to a system of benefit-risk management.
   • Access to patient data – as the management of NHS information evolves, including the creation of the Clinical Practice Research Datalink (CPRD), there is an opportunity to develop a more responsive system which can allow real-time reporting of efficacy by clinicians. This would allow for the level of scrutiny and surveillance data about new treatments and therapies that is needed to support effective post-marketing evaluation of therapies. It is important that this new system is developed safely and securely with the protection of patient data at its core.
   • Development of diagnostics and devices – to support trials and uptake of targeted medicines, companion diagnostics and devices must be developed at the same time. To achieve this it is important that the regulation of medicines is not viewed in a vacuum but links are made throughout development to the diagnostic and devices regulatory pathway. The NHS workforce, including commissioners and prescribers, must be supported to use new diagnostics, medicines and devices, and the benefits of doing so articulated clearly.
   • Communication of changes and maintaining public confidence – public confidence is central to a successful regulatory system. Individuals may welcome a more flexible approach to the balance of benefit and risk but such a move must be clearly communicated and developed jointly with researchers, funders and the public.
   Adaptive licensing approaches have the potential to change the drug development model, and we are keen to see the MHRA take a leading role in discussions with the European Medicines Agency (EMA) on the possibility of introducing adaptive licensing. Central to developing this system is patient and clinician confidence in the managed risks and uncertainties involved. Patient and public views must be central to the evolution of regulation. We look forward to being part of this conversation.Comment Tags: Clinical Trials Directive, medical research charities, patient organisation
6. David Ryner on April 12, 2012 at 10:18 am said:

   My comments reflect my position as a Trustee of a rare cancer patient group, which is in turn a member of several rare cancers/diseases group coalitions.

   We welcome the clear shift in MHRA policy, evident since the spring of last year, towards a proportionate and risk adapted approach, just as we do the streamlining of processes to ensure a timely, efficient and productive regulatory system.

   However, we remain concerned at the possibility for local R&D approval to act as a reverse gear to the forward momentum built up elsewhere for reform.

   There is no reason why similar streamlining, centralizing reforms that have been suggested could not be enacted to resolve this issue.

   Save for this issue we believe the current reforms serve as a showcase worthy of emulation by those EU Member States hampered by sclerotic regulatory regimes.

   The EU Commission also seems to be moving their position significantly with Commissioner Dalli stating in a speech last month that their view is that the revised legislation should be adopted as a Regulation rather than a Directive.

   Provided its contents are robust, fit for purpose and address the known deficiencies of the current Directive, we hope support will be given to secure a successful legislative outcome.

   Whilst we expect patient safety concerns to be addressed, we do not wish this to become a fetish.

   Proportionate risk, as patient surveys have demonstrated, is a principle well understood and accepted by patients themselves.

   This especially applies to patients with malignant disease facing a lack of efficacious therapeutic options.

   For them the certainty of death, should they not act, is a massively powerful incentive to enter a clinical trial. Our hope is for a future where patients do not have to migrate out of EU27 to become clinical trial participants as a result of policy makers and legislators failure to act appropriately and responsibly.

   Finally, we welcome the Prime Minister’s visionary thinking when discussing clinical trials and personalised medicine in his Council for Science & Technology paper ‘The NHS as a Driver for Growth’.

   In particular we agree with the statement that “we need to find new ways to trial new treatments” and that this might mean “the elimination of the requirement for extensive phase 3 studies in drugs with outstanding efficacy that provide the results expected from stratification.”Comment Tags: Clinical Trials Directive, patient organisation
7. William LaChenal on April 8, 2012 at 11:13 pm said:

   The Placebo

   From time to time there are innovations in the design of trials, and the science of investigating phenomena.

   Legislation must be flexible enough to keep purveyors of trial results honest (and accountable), without stifling innovation.

   Thus any innovation in the scientific method must statutorily be honestly reported.

   One such recent innovation is so-called “placebo washing”, where a target population is first tested with an accepted placebo, and those who respond are removed from the trial.
   It is an interesting development, I have no doubt it would not have become commonplace if it did not seem to enhance trial results.

   I do not object to this innovation per se, but again I think it is important that where placebo washing is part of an investigation, it must be honestly reported, & not vanish from the record.

   I also believe that far more attention should be paid the the exact placebo used in a PCT, and it should be a requirement to state precisely the specification of the placebo in any report.

   The same thought applies to excipients, casings, bases etc.
   If it is not a requirement to state the precise descriptions of these, valuable information may be lost.

   I rather hope that EBM will expand and fulfil its purpose rather than further narrowing its approach to faulty meta-analyses & often poorly-designed (and poorly-understood) RCTs. This will mean returning to other elements of EBM using real-world clinical observation, such as cohort studies, collation of case reports, case series, case control studies, etc. etc.
   It should be understood that such adjunct studies could make or break the profitability of a commercial medicine, and as such it will no doubt be necessary to legislate to keep these processes honest!Comment Tags: honest reporting, placebo, placebo records, placebo washing
8. William LaChenal on April 8, 2012 at 10:23 pm said:

   All trials are “interesting”, in the sense that every positive integer is an “interesting number”, but it should be remembered that they show exactly what they show & no more. The tendency to fanciful interpretation and extrapolation is unfortunate.

   I am concerned about the quantity & quality of clinical trials which appear designed to fail, or designed to be misinterpreted, or designed to show dangers which are unlikely in practice to arise.
   These are what I might call knocking trials, designed to discredit a competing product.

   I would like to see this practice discouraged, but without wishing to stop investigations which are genuinely inquisitive.
   Ideally, one would like to be able to trust the various reserch committees to exercise good, unbiased judgement, but I fear it can be demonstrated that this is not the case.

   I regret I do not have a clear statement of desirable requirements to contain this problem; I have no doubt there are very able civil servant who can do this.

   I give a short selection of a few of the sorts of trial to which I refer, examples of each of which can be found:

   Supplementation of, say, a specific vitamin for a general population not all of whom are deficient or out of balance in that vitamin.
   Supplementation of a specific vitamin (say) for a correctly selected population at dosage levels unlikely to be therapeutic, or of a faulty chemical analogue of the “headline” vitamin.
   A trial using wildly excessive doses which is marked as an effectiveness trial & not as a toxicity trial.
   A trial of a remedy plus excipients, where the excipient mix is not separately tested & compared.
   A trial against a selected placebo which may not be as inactive as supposed.
   A trial against an population which is clearly inappropriate.
   A trial in circumstances which are clearly inappropriate.
   (I am thinking of the clinical trial of non-penicillin resistant probiotics given at the same time as courses of oral penicillin antibiotic treatment. This was blatantly close to fraud, attempting to prove that probiotics are ineffective by deception, but nevertheless interesting in its own right. The correct & obvious clinical practice is instead to supplement probiotics after finishing antibiotic treatment.)

   And (an area in which I am particularly interested) any ill-conditioned trial of individualised therapies, where a remedy is asked to work against a specific disease in a general population regardless of correct individualisation. One sees many of these ill-conceived knocking trials in areas of holistic “alternative” medicine; nevertheless, with advances in individually genetically-based therapies, this may become a significant problem for innovative conventional approaches, too.Comment Tags: bad science, discrediting competition, knocking trials
9. William LaChenal on April 8, 2012 at 9:32 pm said:

   One specific point, regarding:

   The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
   No. 1928
   Insertion of regulation 31A of the principal Regulations
   31A.
   (7) The sponsor and the chief investigator shall ensure that the documents contained, or which have been contained, in the trial master file are retained for at least 5 years …

   It is, I believe, generally accepted that it takes at least ten (10) years for a new syndrome to be recognised, or for significant undesirable effects of a marketed pharmaceutical to be noted & acted upon.

   This is particularly so with fashionable super-remedies, such as synthetic plant statins, Vioxx, Prozac (etc.), the daily aspirin, oral sodium flouride, the list goes on.
   Even after serious adverse effects are recognised, there is often resistance to full acceptance of the facts (it’s a cultural thing).

   In view of this, there should be further research into what I may call “the mean time to recognition of adverse effects”. Based on this, the time for which master files should be retained should be increased to at least that period plus, say, an arbitrary 50%.

   I am unhappy that by the time a serious side-effect becomes properly recognised, any documentation which may either through light on the seeds of the problem, or may demostrate innocence, would legally have been destroyed or lost.
   I am puzzled, therefore that current statutory retention time is limited to only five years.

   As an interim measure, I believe the public, and pharmaceutical science, would be well served by having the standard retention time increased to at least fifteen (15) years.Comment Tags: evidence, Records, retention time, side-effects
10. Linda Pollard on April 4, 2012 at 8:04 pm said:

    All clinical trial data must be pre-registered and published, whether favourable or not.
11. Sarah Rickard on April 4, 2012 at 12:43 pm said:

    Response from Greater Manchester, Lancashire & South Cumbria Medicines for Children Research Network

    Lack of detail in MHRA approval letters: The lack of any reference to the documents assessed by the MHRA as part of their review can mean it is very difficult to establish exactly which documents relate to a particular approval letter. A recent MHRA inspection conducted at our Trust resulted in a major finding which could have been avoided if version numbers and dates of documents reviewed were included on the MHRA letters. For this particular study, the MHRA did not approve the original version of the protocol but requested some minor changes and approved version 2. The REC however did approve the original version. Our R&D department issued approval of the original version protocol as they were under the impression that the MHRA letter did cover the original version of the protocol as no version number or date was evident on the letter.

    Issues with communication: The standard email response of ‘we endeavour to provide a response to all enquiries as quickly as possible, within the Agency’s target response time of 20 working days from the date of receipt your enquiry.’ is not particularly helpful when attempting to work to tight timelines (often demanded by industry). Also, the MHRA website is not particularly easy to navigate. For example, the fees relating to assessments of medical devices differ according to the class of the device. It was however extremely difficult to locate the section of the website which defined the class of device – it would be much easier if there was a link in the same section as the fees.

    Over classification of CTIMPs: Investigators are put off developing important studies involving products such as honey and fish oil that are deemed Investigational Medicinal Products by the MHRA. A CTIMP is far more expensive and onerous to run and so classifying this type of product which are often low risk in this way deters many researchers from embarking upon trials for treatments that could be both efficacious and more cost effective for the NHS.Comment Tags: Research Network
12. Roy Taylor on April 2, 2012 at 4:31 pm said:

    To remove unnecessary and inhibitory regulation from non-pharmaceutical medical and physiological research.
    1. The decision within the UK to extend the heavy-duty regulation needed for pharmaceutical trials to studies of pathophysiology has led to enormous disbenefit. Important research on the pathophysiology of disease has been delayed or prevented.
    2. Specifically, use of already licensed drugs as part of academically led clinical research must be recognised as not requiring the regulation appropriate for novel and potentially dangerous agents. One example would be use of lipid lowering drugs to change metabolic conditions so that inter-relationships of metabolism can be tested. Such basic clinical science is of enormous importance, and is an area in which the UK used to excel.
    3. Consideration should be given to releasing from MRHA regulation all studies not involving new drugs or not primarily led by pharmaceutical companies. Ethics permission and NHS R&D permissions will still be required, and these layers provide very adequate controls.Comment Tags: clinical research
13. Professor Colin Garner on April 2, 2012 at 11:15 am said:

    The introduciton of the European Clinical Trials Directive has severely impacted the conduct of human trials such that these are very difficult to conduct. The Directive has caused academic and commercial clinical trials to be substantially reduced in number in the UK severely impacting our ability to develop new medicines. The Directive has caused a vast increase in bureaucracy, expense anbd time to udertake trials. Itr has introduced new barriers between EU countries as each interprets the Directive differently. The Directive has led the UK to move from being a good environment to conduct clinical research to one which lags behind not only other EU countries such as The Netherlands but also the USA. The result has been that clinical trial business has been lost overseas. The Directive needs substantial modification by a) reducing the paperwork for trial submissions to the MHRA b) altering the drug manufacturing quality requirements for early phase trials to reflect the fact that experimental drugs are being evaluated c) a reduction in the costs of trial submssions for academic investigator led research d) a clearer distinction between what consitutes a clinical trial for drug development and what constitutes advancement of clinical knowledge. The [Text deleted] incident in the UK has caused an over reaction in the cliical trial approval process. Incidents like [Text Deleted] are very rare and we must balance the risk of conducting trials against the benefit of finding new medicines.Comment Tags: Clinical Trials Directive, Exploratory Clinical Trials
14. Fran Percival, on March 30, 2012 at 2:54 pm said:

    Recognition of the need to understand the impact that medicines have outside the constraints of a clinical trial has led to a recent growth in the number of non-interventional, “real-world” studies. These fall outside of the UK Clinical Trial regulations where the medicine is licensed and used within its marketing authorisation, allowing pragmatic research to be undertaken.
    We believe that it would also be helpful to be able to gather some data on the patterns of use and outcomes in normal clinical practice, of medicines that have completed their clinical trial programme, but are awaiting licensing, either in the UK or worldwide. Some of these medicines are made available to patients at the request of clinicians via ‘compassionate access ‘ schemes, and collecting data on how these patients respond to treatment could provide a valuable ‘real-world’ supplement to the clincal trial data. However, currently any such data collection would be classed as an interventional study, requiring full review by the MHRA, because the drug is not yet licensed. The burden of documentation required for this review makes such small-scale pragmatic data collection infeasible and we would support the adoption of a risk-based approach to the regulatory scrutiny of such data collection exercises, if they cannot be reclassified entirely as non-interventional studies.Comment Tags: non-interventional studies, real-world studies
15. Jonathan Grigg on March 29, 2012 at 1:08 pm said:

    I am doing independent clinical trials supported by national grants. The MHRA initial approvals process I found good and not too burdensome. However, the inspection process has lead to a culture of sclerosis in NHS R&D departments. I thought that this was a problem with R&D – until I was recently targeted for inspection by the MHRA. The inspection of my trial – which uses a licensed medication in its licensed indication – but in a slightly different way – was disproportionate and wasteful. In the 4 hr interview – the issue for the inspector appeared not to be one of safety – but every miniscule aspect of the EU legislation related to record keeping, contracts, and filing. It seemed more important to the inspector that we had not got a formal contract with an academic group in continental Europe who were kindly doing an exploratory urine analysis – or that I had not filed one of the first letters from the MHRA requesting additional information (I had filed the final approval letter). Although the MHRA has now made a half-hearted attempt to introduce “light touch” oversight – this was certainly not apparent for my trial. I suspect that input by a clinician into the oversight process would have produced a more balanced inspection. My view -the current inspection process is highly wasteful – its obsession with minutiae has increased significantly the costs of performing independent trials. Overall this discourages academic asking important questions – questions that may be of little interest to industry since IMPs are often off patent- but of major importance to patients.Comment Tags: Trial inspection
16. Fiona Maggs on March 27, 2012 at 3:06 pm said:

    I have found the change last year from the annual safety report to the DSUR has created an enormous increase in the paperwork. A lot of this form is irrelevant to the particular study I was reporting on and it is not straightforward to complete. Other health professionals have also reported to me that they have found it a difficult form to complete.
    Also why in our current electronic era do we have to send reports on CD to MHRA and not via email. We have to gain specific permission to put any information on CD at the trust I work in and again this creates more form filling.Comment Tags: Increased paperwork
17. Douglas Adamson on March 26, 2012 at 2:13 pm said:

    As a doctor, the amount of paper-work and hoops to jump through has increased in recent years. Some of my collegaues have stopped doing trials because of this and I certainly am going to reduce the number I do in the future for the same reason. An example would be the excessively detailed adverse events reports that pour in with numerous signatures demanded for all. There is no attempt to filter this information and it seems to be given so that if anything goes wrong, someone can claim “we were told”. It’s entirely unhelpful, and if it’s not enshired in the law, huge numbers of people seem to believe it is. Unless the trials process can be made less complicated, we simply won’t be able to continuing doing the number of trials that we are currently doing.Comment Tags: Excessive paperwork
18. Donald Grosset on March 25, 2012 at 9:20 am said:

    There is a duplicative bureaucracy in the setting up of clinical trials in the UK. Central ethics approval for multi central studies is followed by central research and development review in lead sites and is followed by local review by yet more research and development offices. Minor changes then follow the same pathway. This causes delay and is a huge waste of resources.Comment Tags: clinical trials, ethics, research and development
19. Salman Razvi on March 21, 2012 at 12:39 pm said:

    I understand that research governance is required for undertaking clinical research as it is for all forms of ethical research. However, the system, as it is currently designed, is vague, confusing, and delays research. My main issues are:
    1. The area of when a clinical trial is a CTIMP is very confusing and ad-hoc. In one trial of levothyroxine assessing fatigue, this was classed as a non CTIMP whereas another trial assessing appropriate doses was classed as a CTIMP. For the latter trial, the cost of the project has increased by at least 50% and has delayed it by a good few months. And to think, that we were assessing a licensed medication in licensed conditions (hypothyroidism).
    2. The regulations,as they currently stand, make interventional trials cumbersome and require a significant amount of bureuacratic paperwork even for interventions that are straight forward.

    I worry that if this does not change then performing high quality research by academics is going to be unsustainable. Patients and society will suffer as a result.
20. Michael Bowden on March 20, 2012 at 5:45 pm said:

    In general, the regulation of medicines is proportionate. One area where improvement can be made is to avoid duplication at the national level where EU legislation is already appropriate, and to avoid “gold-plating” EU legislation. An example is the extra mechanism over and above Eudravigilance for reporting clinical trial SUSARs.Comment Tags: duplication, gold-plating, pharmacovigilance