QUASAR MAGAZINE
INFORMING AND ADVANCING OUR MEMBERS
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QUASAR MAGAZINE
BOARD UPDATE
THE RQA MANAGEMENT COMMITTEE The RQA Management Committee was formed in June 2015 as part of the major remodelling of the Association’s Board and management structure. The Committee comprises of the chairs of each of the RQA Committees – AVPC, DIGIT, GCP, GLP, GMP, GPvP and Medical Devices, with input and support from the Volunteer Programme Lead.
P
rior to June 2015, the RQA Committee Chairs had been Board members and Company Directors; a role that required them to attend all Committee meetings and all Board meetings. That arrangement, while providing direct contact between Board and Committees, mainly dealt with operational issues which forced the Board to set up other Committees to deal with Board-related matters such as Finance, Strategy and so on. The Management Committee meets face-to-face twice yearly – in January to formulate the strategy for the coming year and in August to review the progress of the strategic objectives. Those meetings are held with the RQA Board to facilitate the development and delivery of a strategy which will fulfil RQA’s Mission: 1. To develop and promote quality standards in scientific research. 2. To facilitate knowledge sharing and transfer through discussion, training, seminars, forums, conferences, publications, partnership and co-operation. 3. To liaise with regulatory agencies in the development and interpretation of regulations and guidance.
Interim teleconferences are held to bring all the Committee Chairs up-to-speed with any changes and significant updates. The Management Committee meetings foster effective communication between committees and promote collaboration, which often leads to projects and assignments, such as data integrity, which are cross-committee initiatives. All new product development activity is captured and monitored in the RQA product pipeline. A simple Gantt chart is used to map each new product and the progress of its development. The Management Committee reviews the chart quarterly to ensure that new products remain on-schedule for delivery. New products are essential to the Association and its members, they add value to RQA membership and allow the Association to grow; the new and increasing value keeps the organisation ahead of its competitors. The Volunteer Programme has provided an additional pool of resources for the RQA Committees. Whether it’s a one-off task or a continuing role, the Committees often look to the Volunteer Programme for any additional resource. Without the input and support from RQA Committees and the Management Committee, the Association wouldn’t operate effectively. The Management Committee is a vital link between the Board, the committees and the members.
APRIL 2019 | QUASAR | 5
INTERNATIONAL EDITION
Matthew Emmerson
RE-EVALUATING GOOD CLINICAL PRACTICE (GCP) FOR THE MODERN ENVIRONMENT DOES GCP NEED UPDATING IN RESPONSE TO CLIMATE CHANGE?
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INTERNATIONAL EDITION
I
t might seem like an odd question to ask, after all what do clinical trials have to do with global warming? 23 years ago when GCP was first published, the link was distant as conceptually modern trials and climate change were both in their infancy. However, since then, they have become progressively more intertwined. As clinical trials have expanded in size, both in terms of patient numbers and global scale, their carbon footprint has significantly increased. At the same time, evidence is mounting that climate change is a significant threat to future and present global health 1, with the WHO projecting 250,000 extra deaths per year as a direct result 2. The focus of GCP has always been primarily introspective, looking at protecting the patient within the trial above the rest of society. However, as trials now contribute to a global health problem from which the whole of society is at risk, perhaps we need to look at updating GCP to protect not only those within the trial but those outside and require that trials are designed and conducted with the environment in mind.
WHY DOES IT MATTER? Why make trials eco-friendly? What is the value in this? There are two main areas of benefit to making trials better for the environment – ethical and economic.
ETHICAL From their first inception, the purpose of clinical trials and the design behind them has been to enhance and advance human health and treatment. The aim of the modern trial process takes this to a global level, allowing people worldwide to share the benefits of drug and intervention development, irrespective of location. With growing evidence that climate change will cause further health problems1, if we do nothing to curb our contribution to energy use and atmospheric emissions, and thus a growing health threat, can we really claim to fulfil this original mission?
This is particularly pertinent when we consider that the majority of trials are conducted in high-income countries3, but the worst impacts of climate change will be felt by low-income countries such as those in Africa1. This means that those with the least input stand to suffer the most from us not considering the environment. Within the trials themselves, the aims of the regulations and GCP (including its precursors) have been to apply the best ethical standards of the day to protect all those involved and impacted by the trial. It can therefore be argued that if we wish to espouse the best ethical practices of the modern, global era, we need to take a more egalitarian approach. We must consider factors beyond those groups in the specific scope of the trial and assess the impact of the trial on a global level, both in terms of the benefits of the results it will generate and at what cost to the environment those results will come. This will ensure that we continue to fulfil the purpose of clinical trials and GCP in the changing global arena.
OCTOBER 2019 | QUASAR | 13
INTERNATIONAL EDITION ECONOMIC
WHY GCP?
HOW WOULD IT WORK?
Whatever your opinion on environmental policy and the rate at which this progresses in each country, the reality is this: it is not a case of if, but when, clinical trials must become eco-friendly. The UK government aims to outlaw petrol cars by 2040 at the latest 4, there is increased investment in renewable energy 5 and public demand for change grows in many countries. Environmentally friendly ways of working are therefore a requirement of the future, rather than an option.
This is perhaps the most important question to answer in the context of the article – why does GCP itself need to be updated for climate change? Why not do this on a company or country level? The simple answer: this is the only way it will work.
Rationale explained, how could this work? Where would climate change sit within the existing framework of GCP and the regulations, and how could it be implemented?
The closer we get to when change is required, the more difficult and expensive it will become to make it – many might remember the manic rush to compliance in the run up to GDPR becoming live in May 2018, and the price tag associated. In the interim, it will also become more expensive to maintain existing practices, for example the cost of shipping due to rising fuel prices. This increased cost has the potential to be felt in two areas. The first is that it will potentially price out smaller companies from the already competitive market. The work that these companies do can be of vital importance, however if the projected costs for trials spiral, there is the risk that compounds and treatments with the potential to make a significant difference do not get tested, particularly in a process that does not guarantee a favourable outcome or financial return. The other impact is to the cost of the end product. In the commercial pharmaceutical industry, profit is critical and must be to allow further research to be possible. Increasing operational costs of trials therefore have the potential to drive up costs of the interventions which they produce. Proactively mandating that trials are environmentally friendly will ensure that, where possible, the long term financial cost of the trial in response to environmental factors is considered, reducing the overall cost of trials. This in turn can reduce the cost of the end product and would offer further ethical benefits, such as potentially wider access to the end product by those involved in the trial, as required by the Declaration of Helsinki 6. It is therefore imperative that we implement change now to ensure trials are economically viable in the long run.
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In order to have the impact needed, a consideration of the environment in trial decision making cannot be optional or vary from region to region. It needs to be universal, with everyone globally working to the same basic set of harmonised standards, requirements and principles – precisely the aim of GCP. Different locations may choose to implement stricter standards, in the same way that while GCP requires archiving for two years post marketing approval or end of development7, the EU has opted for 258, but the minimum standard is met by all. If there is any degree of option, experience tells us it will not happen. It should be acknowledged that Section 11 of the most recent version of the Declaration of Helsinki does explicitly say that research should be conducted in a manner that minimises possible harm to the environment6, and is therefore included indirectly in the GCP guidelines. However, to have the necessary impact it is arguably needed at the forefront of considerations, in the guidelines themselves. Changes to GCP regarding the environment will also ensure that it is implemented on a systemic trial design level, ensuring greater effectivity. With modern trials, it is easy for companies to have an isolated view of their role in a trial and those below the sponsor/ CRO level will often only have access to the final protocol, acting as instructed after the point when change is possible. The trial itself must therefore be designed to be environmentally friendly at a protocol and regulatory level to have the greatest impact, to ensure that from the top-down the environmental impact is considered. This is the difference between a company sending supplies for a visit in as few shipments as possible, versus needing to send them at all.
'In order to have the impact needed, a consideration of the environment in trial decision making cannot be optional or vary from region to region.'
It should be stated from the start that I don’t have all of the answers, either ethically or operationally. The concept is still in its early stages and to have the required effect would likely need a wholescale change across the industry, from the regulators, to the sites, to the patients, globally. We therefore need time to determine how this can practically be implemented and where the ethical line needs to be drawn between being beneficial to the patient and data, and harmful to the environment. While operationally we determine how this might be achieved, the update would sit best in the GCP principles themselves to allow it to be mandated into decision-making without being too prescriptive and holding companies to potentially unrealistic requirements. What follows are my personal suggestions on how this transition in approaching trials might work. Whether you agree or disagree on the mechanism or need for change is entirely fair; if there was agreement it would be de-facto rather than a debate. The important thing is that this dialogue is happening. There is a trend of regulatory guidance and legislation being behind the curve – think how long computer systems have been used in trials and when ICH E6 R2 came into effect. It is therefore imperative that we start discussing this now as with the critical impact that climate change presents, we cannot afford to wait for a decade after the change was needed before we look to change ourselves.
OPERATIONS GO PAPERLESS Paper is the environmental equivalent of burning the candle at both ends – taking trees out of the environment and generating more pollution in the process. Furthermore, it then needs to be archived in environmentally-controlled conditions for two years minimum, using up further energy. Clinical systems are increasingly computer based, but there is still more that can be done. A full transition to electronic records would have the potential to reduce carbon emissions in the short term and enhance this gain even further in the future when we can afford emissions even less.
INTERNATIONAL EDITION REDUCE TRANSPORT
ARTIFICIAL INTELLIGENCE
The increased levels of transport in trials is the inevitable drawback of them operating on a global level. In 2008, transport accounted for 23% of global CO2 emissions9; in trials this proportion is likely to be higher, as other groups included in the WHO percentages such as agriculture, energy industries and construction do not play a significant factor in clinical trials. However, with technology facilitating remote interaction, it also presents an area which can be made significantly more eco-friendly with relatively minor changes.
With more data at our fingertips than ever before, we must be smarter with how we use it. Artificial Intelligence (AI) has the potential to look at data in ways that people cannot, improving the decisions made and enhancing the overall efficiency of trials. Precisely where AI will be used in the long-term is not certain, however with the number of avenues being explored in new articles and publications, there is no doubt that it has the potential to significantly reduce carbon emissions in trials and that this will only increase with more data available.
This can apply at all levels, including reducing the amount of travel from the patient to the trial centre, increasing remote auditing and minimising the need for events such as investigator meetings where hundreds can be flown to a single location for training purposes.
INTEGRATING TRIALS WITH HEALTHCARE AND EACH OTHER Tied to the drive to reduce transport, perhaps the most ambitious but also the most beneficial way to reduce the carbon footprint of trials is to integrate them with routine healthcare as well as other ongoing and previously conducted studies where possible, rather than often being more stand-alone entities. The best trial is the one which acquires the necessary data with the fewest patients. Each day, thousands of diagnostic tests are run globally, from blood samples, to pain scores, to respiratory tests and there are over 39,000 trials with available results in the WHO database (as of August 2019). We therefore have a largely untapped reservoir of data, increasing daily, on which to base decisions and test hypotheses if it can be accessed. This would allow us to minimise unnecessary testing, reduce patient travel and even reduce the number of new trials overall. Invariably this suggestion raises the question of informed consent – would people be willing to have their medical data accessed? However, in 2019 the law which makes people organ donors on an opt-out basis in England passed parliament with relatively little fuss (a 2017 poll by the British Medical Association suggested 65% of people would approve of such a scheme)10. When combined with research demonstrating people’s generally positive perceptions of clinical research12 this means the precedent is arguably there that, with the right education and security measures in place, people would be willing to help others by participating in research by default.
REFERENCES 1.
Watts, N., Amann, M., Ayeb-Karlsson, S., Belesova, K., Bouley, T., Boykoff, M., Byass, P., Cai, W., Campbell-Lendrum, D., Chambers, J. and Cox, P.M., 2018. The Lancet Countdown on health and climate change: from 25 years of inaction to a global transformation for public health. The Lancet, 391(10120), pp.581-630.
2.
World Health Organisation. Feb 2018. Climate Change and Health. [Online]. [4 August 2019]. Available from: www.who.int/ news-room/fact-sheets/detail/climate-change-and-health
3.
Drain, P.K., Parker, R.A., Robine, M. and Holmes, K.K., 2018. Global migration of clinical research during the era of trial registration. PloS one, 13(2), p.e0192413.
4.
Harrabin, R. Apr 2019. Climate change: Electric car target 'needs to be sooner'. [Online]. [4 August 2019]. Available from: www.bbc. co.uk/news/science-environment-48097150
5.
Deign, J. Jan 2019. Global Renewable Energy Investment on the Rise. [Online]. [4 August 2019]. Available from: www. greentechmedia.com/articles/read/global-renewable-energyinvestment#gs.tmsd2n
From an ethical perspective, the main balance that will need to be struck is whether the ideas above, or any others that are put forward, can be implemented with sufficient quality systems to ensure that we do not significantly compromise patient safety or data integrity.
6.
World Medical Association, 2013. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Available at: www.wma.net/policies-post/wma-declaration-of-helsinkiethical-principles-for-medical-research-involving-humansubjects/
7.
ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for good clinical practice E6(R2) (2016) Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf
Can we go paperless without losing critical information? Can we develop AI to reliably work within the confines of GCP? Can we expand our data pool without subjecting entire populations to unacceptable risk? Moreover, at what point does a risk to the environment outweigh a benefit to a patient or vice-versa and can this be practically mitigated? These are questions that will need to be answered to ensure a harmonised ethical approach to clinical trials.
8.
Regulation (EU) No 536/2014 of the European Parliament and Of The Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [Online]. [Accessed 03 August 2019]. Available from: http://eurlex.europa.eu/
9.
World health organisation. [no date]. Transport Climate Impacts. [Online]. [4 August 2019]. Available from: www.who.int/ sustainable-development/transport/health-risks/climate-impacts/ en/
ETHICS
Until more precise guidelines can be developed on how to reduce the environmental impact of trial, perhaps the best way to ensure the environment is considered in trial design is by requiring an environmental representative on approval committees and within QA groups. This would ensure that the questions are asked at all stages of the trial to make the trial environmentally friendly where possible and ensure that the impact is properly considered and documented.
CONCLUSION Overall, as the environment changes and puts global health at risk, we must look to change GCP with it and mandate that trials are designed and performed to be environmentally friendly where possible. How this will look practically is uncertain, but what is imperative is that we start the dialogue now to ensure that the benefits can be felt before it is too late. Through this we can look to implement a new generation of trials and a new purpose to GCP; one that protects not only the people within trials, but also those outside.
10. Dyer, C., 2019. Organ donation: England’s opt-out system could save 700 lives a year. Majority Clinical Research 11.
Anderson, A., Borfitz, D. and Getz, K., 2018. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA network open, 1(6), pp.e182969-e182969.
PROFILE Originally obtaining a BSc in archaeology in 2014, Matt has worked as a Quality Assurance Specialist at ACM Global Laboratories since 2017, having previously worked in clinical trial project management. He has a keen interest in the use of technology in clinical trials and the next generation of quality. Away from work Matt enjoys Lego Architecture and all things food-related.
OCTOBER 2019 | QUASAR | 15
THEMED
Matt Emmerson
REINVENTING THE WHEEL IN CLINICAL TRIAL QUALITY MANAGEMENT I often hear the phrase that we shouldn’t reinvent the wheel, but I can’t help but think ‘why not? – it’s what we’ve always done’.
6 | QUASAR | JULY JULY2019 2019
THEMED
I
t’s a situation we’re all familiar with. Sat in a meeting, desperately trying to convince the person across the table to implement a change perceived as a departure from the way things have always been done or significant for what appears to be a small obstacle. Eventually, the phrase ‘don’t reinvent the wheel’ or a derivative of this comes up.
Ironically, the phrase is a perfect exemplifier of why such changes are necessary. Since its first creation, estimated to be at least 5000 years ago1, the development of the wheel has been far from static. It has, and continues to be, regularly reinvented and redeveloped to adapt to the landscape and to reflect the best methods, materials and knowledge available to achieve both its desired purpose, and future needs. The same history can be seen in quality systems and the same approach can be taken in their redesign and reinvention to best cope with the changing landscapes of clinical trials. FIGURE 1: ANALOGY GUIDE
Wheel/Rim = Quality System Tyre = Risk Management Vehicle = Company Mechanic = Auditor Wood/Stone/Leather = Manual/Paper Steel/Carbon Fibre/Rubber = Computer/Automated
increased size and complexity of trials and the introduction of more advanced risk-management processes to brace against foreseeable problems. These changes in design, technology and complexity have been reflected in the vehicle above, fundamentally altering the way we use the wheel. It has evolved from being purely reactive, such as in a horse-drawn cart, to being integrated in how the vehicle moves forward, as in a modern car. The tyre has gone from being arguably a secondary component of the wheel, to being integral to how the vehicle operates, and having specific requirements by law. This pattern is mirrored by the role of quality systems in clinical trials and the development in significance of risk management and its requirement under ICH E6 R22.
CHOOSING YOUR WHEEL Historical and present parallels drawn, how can we use this idea of a wheel to evaluate current systems? There are four major areas where the analogy can be applied, although this is far from exhaustive. These are: design, size, materials and feedback.
DESIGN – ONE MODEL DOESN’T FIT ALL Whatever the vehicle, it is vital you pick the right wheel design. There are several places that you can turn to for this, including the ISOs, regulatory guidelines or guidelines from other groups including the RQA.
BACKGROUND
However, don’t just go for the first one you see in the shop or the one that looks fancy. Different blueprints have different purposes in mind and one type will not necessarily fit all.
When talking about the first wheel, the image that may spring to mind is something out of ‘The Flintstones’, complete with a fat caveman in a spotted outfit. Regrettably, the reality was likely more mundane, with competing theories and evidence suggesting potentially multiple origins depending on its use.
For standard roads you may want an all-purpose, everyday wheel. Potential designs for this might be based on ISO 90013 or the MHRA Grey Guide4; both will support vehicles of a variety of sizes, on most road types. They therefore provide an excellent starting point for how to structure a quality system in most organisations.
In the millennia that have followed, the materials for the body of the wheel have progressed from stone and wood, to steel and carbon fibre to better support the increasing weight of the vehicle above. Relatively late, we see updates to the tyre from leather and iron to rubber, to more effectively cushion against bumps in the road.
By contrast, if navigating a specialised landscape or driving an uncommon vehicle, it may be better to pick a similarly specialised wheel; the QA equivalent of the wheel on a Formula 1 car, for example Good Clinical Laboratory Practice5 for central lab testing. Such a design will enable you to effectively navigate the immediate landscape in front, but may struggle if expanded to more varied terrains or applied to a different mode of transport.
Passenger = Patient.
In the same way, the basis for quality systems in clinical trials have multiple origins, converging to the same purpose of protecting the patient and the data taken from them. As time has progressed we’ve seen the transition from manual, paper-based systems to automated and electronic where technology has allowed, to support the 8 | QUASAR | JULY 2019
With the wheel design selected, it is also vital to pick a suitable tyre. When designing quality systems there can be a temptation to cover all possible risks, however unlikely, but it can be unnecessary and expensive.
Fitting all-terrain tyres on a hatchback may enable it to drive across desert, snow, bogs and steep hills, but unless this is likely in the foreseeable future, it will only serve to slow you down on a daily basis and put a large dent in your bank balance. At the same time however, a tyre with minimal tread will struggle to gain traction on even a slightly uneven road. The other option is creating your own design. Inevitably this can be a little more work, but in the long run it might be a worthwhile investment. This can be entirely custom made, incorporating the principles of GCP and the regulatory guidelines into a brand-new design. Alternatively, it could be a combination of pre-existing blueprints, taking the best practices and interlinking to create a specialised overall system. For example, with data integrity being an increasingly important aspect of trials, it may be beneficial to incorporate the best practice of ISO 154896 to steer operations and keep the vehicle on the best track, while being driven by a separate design – a proverbial quality systems tractor setup. Overall, whatever the design of the wheel, it needs to match both the landscape below, and the vehicle above. Pick the wrong design and you can find yourself spinning in the mud or out of pocket for an elaborate yet unrequired system.
SIZE – BIGGER IS NOT ALWAYS BETTER The size of the wheel needs to be consummate to the size of the vehicle; big enough to support the weight above, but still allow it to manoeuvre and travel fast. A bicycle wheel is light and agile, but will warp under the weight of a car. However if I were to put 3ft coach wheels on my partner’s Fiat 500, while it would certainly support the weight, I doubt they would be thanking me as it would make it practically undriveable. Similarly, a quality system needs to be strong enough and large enough to support the weight of the company’s activities without buckling and to stop the passengers feeling any bump in the road. However, it must also allow the company to move fast when needed, should the patient’s safety be at risk. If the company size increases, the quality system must support the added weight or be modified accordingly, either with new materials, more wheels or increasing the level of risk management. However, applying a disproportionately large system, such as that designed for a bigger company, can also cause problems as it can slow processes down when they need to be fast.
THEMED MATERIALS – BE SMART
THE FUTURE
CONCLUSION
It goes without saying that where possible, the best technology should be used to build a system as this will better support the vehicle – why use a wooden wheel when steel is available? However, caution needs to be taken when assessing the materials of the wheel in terms of compatibility and impact.
With everything considered, how can we use the model of a wheel to drive future improvement (pun intended)?
To summarise, as the landscapes of clinical trials continually shift, it is imperative that we ensure we have a quality system that can manage them. Key to this is the continual assessment and evaluation of the current performance and the landscape ahead, and picking a different design or reinventing entirely where necessary. This approach will ensure both the safety of the vehicle, but more importantly the passengers, both now and in the future.
There can be the propensity when assessing or updating a system, to try to upgrade to the most advanced technology in a single step, or use technology as a panacea. However this can be ineffective if the vehicle above is not being similarly upgraded imminently (think carbon fibre wheels on a horse and cart). The best solution to a gap in a manual process is not always to replace it with an automated system, but to reinforce the existing system, for example with a manual QC check, as this can have a more significant impact, at least in the short-term, until the linked components are ready to be modified too. Also assess whether the technology adds anything – change for change’s sake can be a recipe for disaster. I could put the same carbon fibre wheels on a Smart car but for the financial investment, the impact on day-to-day performance would likely be negligible compared to say a new engine or better suspension.
FEEDBACK – LISTEN WELL AND RESPOND CAREFULLY Listening to feedback can often be the best way to work out where improvements are needed, whether it’s a warning light showing up on the dashboard or the mechanic discussing the tyres you’re using. Similarly with systems, listen to others in the company about how they feel the system is performing and take on board feedback from auditors to ensure the system is in the best state if a regulator asks to inspect. However, do not take others feedback as gospel or reactively update based on an individual’s opinion; trust your instincts. You know your vehicle, what it needs and how it functions. If something feels wrong with the tyres, don’t wait for an auditor to tell you to get it fixed. Likewise, if they tell you that you need to upgrade your wheels based on their opinion, do some research on whether it is actually necessary. It may be that it is their opinion only or there is a financial bias behind the information, so do not be afraid to question or push back if you disagree.
Ultimately, don’t be afraid to try something new, to reinvent the wheel. People have a tendency to stick to what they know, replicating what they have done in the past. Quality professionals are no different; we keep the classic, reliable system we have consistently used, even as it gets more expensive to maintain and replace. Experience has its place in progress – we need to learn from lessons of the past and revisit old ideas which may be more viable now (the MHRA released a blog in February 2019 which discusses the importance of experience wonderfully7). However, we cannot always rely on experience to design a wheel of the future; the landscapes are simply too different and by the time you see what is ahead, it may be too late to change your wheels. Perhaps the most critical aspect to this progress is embracing new technology. As discussed earlier, while the concept of a wheel has not altered for millennia, the materials used to build them have. We have continuously modified and improved to reflect technological advances all to best facilitate how we traverse the landscape ahead. But what comes next for quality systems? Some prototypes for 'next generation' wheels have in-wheel motors attached to automatic, driverless cars8 and perhaps this is where we will go in the future, with quality actively driving otherwise automated trials. Both are concepts unlikely to have been envisaged by the creators of the original based on the sheer technological gap, but achieve the same fundamental purpose. Technology may also change the way the wheel not only interacts with the vehicle and the road, but the responsible authorities. With the UK parliament pushing for increased transparency in clinical trials9, this may be something the wheel could be reinvented to address if the technology allows. Fundamentally, quality systems in clinical trials need to be designed to protect patients and a level of transparency in performance over which the vehicle above has no control is something that technology could both enable and drive.
REFERENCES 1.
Bulliet, R.W (2016). The Wheel: Inventions and Reinventions. USA: Colombia University Press.
2. ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for good clinical practice E6(R2 (2016) Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf 3. ISO 9001:2015 Quality Management Systems – Requirements 4. Medicines and Healthcare Products Regulatory Agency: Good Clinical Practice Guide (2012) ISBN 978-0117081079 5. WHO. Good Clinical Laboratory Practice (GCLP). WHO, Geneva, Switzerland (2009) 28 pp. ISBN 978 92 4 159785 2 [DOI: 10.2471/TDR.09.978-924-1597852] 6. ISO 15489-1:2016 Information and documentation – Records Management 7. Churchward, D. (Feb 2019). Quality Culture: Learning from History. (MHRA Inspectorate Blog) [online]. Available at: https://mhrainspectorate.blog.gov.uk/2019/02/28/qualityculture-learning-from-history/ (Last accessed 28th April 2019) 8. Elaphe (Mar 2019). Technology should be felt but not seen: The next generation of cars enabled by Elaphe in-wheel technology (Elaphe News) [online]. Available at: https://in-wheel.com/ technology-should-be-felt-but-not-seen-the-next-generationof-cars-enabled-by-elaphe-in-wheel-technology/ (Last accessed 28th April 2019) 9. House of Commons Science and Technology Committee. (2018). Research integrity: Clinical trials transparency; Tenth Report of Session 2017–19, HC 1480, 30th October 2018.
PROFILE Originally obtaining a BSc in archaeology in 2014, Matt has worked as a Quality Assurance Specialist at ACM Global Laboratories since 2017, having previously worked in clinical trial project management. He has a keen interest in the use of technology in clinical trials and the next generation of quality systems. Away from work Matt enjoys Lego Architecture and all things food-related.
Alternatively, it could be something else entirely which may or may not yet exist in another field, the irony is we may not know until someone tries it and finds it works, but the key is to keep trying. In the modern era, a trial cannot function without a suitable quality system in place from the start, so the onus is arguably on us to pre-emptively design the system which will allow trials to cover new ground.
JULY 2019 | QUASAR | 9
VIEWPOINT
CREATING SOPS IN AN INNOVATIVE ENVIRONMENT
I
have worked in a surprising array of scientific environments. One of the most notable, required me to autonomously create a quality framework focussing primarily on SOPs, in an innovative yet already functioning department. The existing SOPs were complex and difficult to read. Following one particular audit, we had a finding that required a compliance sign-off system. However, staff refused to sign to say they would carry out a process documented in SOP that they hadn’t written. The purpose of my role was dismissed as ‘document administration’, but I needed to implement a suite of SOPs somewhere it wasn’t entirely welcome. Everybody thought they wanted it, but only on their terms. In order to be able to implement it properly, I had to really understand what was needed. Then, once I understood, I had to explain to everyone else and get them onboard. It surprised me because everyone knows what an SOP is, right? It’s there for reference and every few years it gets reviewed, it gets signed-off and then everyone’s notified there’s a new version. Simples.
Actually, I noticed that people actively shy away from SOPs. They don’t want the responsibility of updating; hate sitting on the review committee; signing compliance statements is a tedious tick-box exercise. For me the opposite is true. Clear communication is one of the hardest things to get right in a complex and changing environment, yet it is so crucial. An SOP is the ideal way to ensure that the information you are trying to convey is being understood; an excellent starting point to get a dialogue flowing; stimulating debate and allowing all areas of an organisation who have input in a process to have that understood. This, in turn, can ensure that everyone is confident in what is expected from them. Writing the first draft of an SOP is daunting, what information to write, being reprimanded for writing something incorrect, having your work picked apart. The unfortunate reality is that in many organisations, you are reprimanded for inaccuracies in a draft SOP. I’ve experienced it. It’s nonsensical to me. There surely couldn’t be a better learning opportunity than documenting your own understanding and then discussing it with your peers?
It is tedious and protracted when you have a million conflicting priorities, but surely it is better to ensure that all staff are clear on their expectations? Then, when one person understands, it can be communicated to everybody else. And when it no longer fulfils its purpose, there is a clear process in place to ensure an amended procedure meets all requirements. No judgement, just discussion. I coordinated the creation of a suite of 32 SOPs by the time I left that job. Some colleagues were more amenable than others but despite the resistance, the SOP Committee meetings I chaired were enjoyable. The Committee experienced a sense of fulfilment (and relief ) when they could finally say “I think that process works”. And there was ultimately a genuine sense of achievement for each author when I circulated a notification that their SOP had been signed off. An awful lot of work goes into an SOP in an evolving environment, but the effort really can and should be worthwhile. HEATHER DORRICOTT Freelance JANUARY 2020 | QUASAR | 39
BOOK REVIEW
BOOK REVIEW
A REFRESHED PERSPECTIVE ON THE IMPLEMENTATION OF WELL-ESTABLISHED QUALITY IMPROVEMENT INITIATIVES BY JENNIFER BELL
S
tatistical Process Control (7th Edition) by John Oakland and Robert Oakland applies to industry, academia and the public sector, including drug and medical device development processes. Both authors are consultants with decades of industry experience. Indeed, John Oakland wrote the first edition of this book in the mid-eighties. Effective implementation of statistical process control contributes to market competitiveness and increased profitability for many successful organisations. For those interested in process control for quality management and process improvement, the book is informative and not intimidating. The content allows for self-instruction by those unfamiliar with statistical process control. Statistical Process Control gives examples for implementing quality management and business excellence systems and lean and six-sigma initiatives. Each chapter outlines learning objectives at the start, provides case studies and refers to appendices as applicable for supporting information in the body and summarises chapter highlights at the end including references for the reader to follow-up on if desired. Each chapter ends with discussion questions and worked examples to promote group interaction. The appendices, glossary of terms and the index provide further clarity to the reader. Additionally, the publisher’s website www.routledge.com provides supporting Excel spreadsheets of data tables and corresponding assessments in the book to ease data transfer into statistical software packages to conduct analyses. Overall, the book gives a refreshed perspective on the implementation of well-established quality improvement initiatives. It contributes to driving cultural improvement by helping departmental perspectives to blend and align to reach the common goal of producing fit for purpose process outputs. It highlights common behaviour found in companies attempting to manage out-of-control processes, remove waste and redesign business activities. The book presents questions that ask whether to replace detection strategies with prevention strategies.
In focusing on prevention strategies, the emphasis is on activity at the front end of the process, e.g. quality by design (QbD). This approach saves effort, time and money spent on detection of issues near the end of processing activity. Statistical Process Control outlines quality design and conformance costs. The described quality costs contribute to understanding approaches for right first time, meeting specifications and avoiding the cost of getting it wrong. As variability decreases, quality and productivity increase and statistical methods of quality control help visualise this at various time points in relation to the whole. Processes are the central theme running throughout the book; processes require understanding, have variation, must be controlled, have a capability and need improvement – these form the five sections of this valuable textbook.
In summary, Statistical Process Control presents approaches for those wanting to understand and apply controls to the total quality strategy of their company to enhance profitability. Statistical Process Control (7th Edition) by John Oakland and Robert Oakland is available from all leading booksellers and online retailers.
PROFILE Jennifer holds a PhD Molecular Microbiology and an MSc in Pharmaceutical Manufacturing Technology. She has worked in QA roles in medical device and pharmaceutical manufacturing and clinical trial sectors since 2010.
APRIL 2019 | QUASAR | 35
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