Clinical Contract Development and Trial Oversight - Online Training ReportClinical Contract Development and Trial Oversight - Industry Report 2011

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Contract Development Online Training Industry Overview. Published by Pharma IQ Sector Report & Resources July 2011 …

Contract Development Online Training Industry Overview. Published by Pharma IQ Sector Report & Resources July 2011


+ Increasing transparency in clinical outsourcing
+ Balancing Ethics with Economy in
+ Outsourced Clinical Trials
+ India Looks to a Future in Clinical Trials
+ Additional Resources
+ Contract Development Online Training

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  • 1. Contract Development Online Training Industry Overview Pharma IQ Sector Report & Resources July 2011 Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 2. Contents 3. Increasing transparency in clinical outsourcing 5. Balancing Ethics with Economy in Outsourced Clinical Trials 7. India Looks to a Future in Clinical Trials 9. Additional Resources 11. Contract Development Online Training Authors: Andrea Charles | Cristina Falcao| Helen Winsor Pharma IQ 2010 - 2011 Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 3. Increasing transparency in clinical outsourcing In the pharmaceutical industry, the majority of companies now outsource the clinical trial process, with a massive 67 per cent of pharma and bio organisations outsourcing more than half of their trials. Companies recognise that clinical development is both unpredictable and timeconsuming, and it is estimated that inefficiencies in the process lead to seven out of ten trials being delayed or cancelled, at a cost of $1.1 million (£680,000) in daily prescription revenues. As a result, many organisations are focusing on establishing contract research organisation (CRO) accountability, running trials in emerging markets and entering into risk-sharing partnerships as potential, albeit risky, means of smoothing this process. However, an obstacle for many is a lack of transparency and consistency in the global clinical outsourcing process – an issue recently addressed by SOMO, a Dutch nonprofit organisation. A recent article in Outsourcing Pharma highlighted how SOMO is calling for a global compulsory register of all contractors and subcontractors involved in each clinical trial to be created for this purpose. This is because the evolution of the outsourcing and offshoring of clinical trials has led to concerns that regulators have failed to keep up with changes and has increased the focus on the efforts made by CROs and sponsors to self-regulate conduct in these trials. The SOMO report explained: "It remains an area of grave concern that the parties that earn most money with the trials - CROs and sponsors - seem to be the most important monitors in non-traditional trial regions". In order to make the process more transparent, the organisation recommends the creation of a worldwide compulsory trial register, in which all parties involved in the trial are disclosed, including any contractors and subcontractors. Such a measure would help to build on national and international trial registry initiatives and explain any grey areas, the firm claims. In particular, including subcontractors in the register would address concerns about the impact of CRO outsourcing work, as SOMO claims that CRO "fragments clinical trial-related tasks further" and could lead to "a lack of comprehension of the full trial process". A survey of sponsors carried out by the organisation found that CROs need to inform them when subcontractors are used, as in many instances prior consent is required, while concerns about regulators are also lingering. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 4. The SOMO study noted that there was a distinct unwillingness to share informationand the company expressed its concern at the "extreme lack of transparency of CROsin particular and of the pharmaceutical sector in general".Some of the other recommendations in the report included increasing overseasinspections and including participants views in inspections and audits, as well asmaking independent verification of Declaration of Helsinki compliance part ofmarketing authorisation applications.According to the Dutch firm, it began research on the report expecting to findpharmaceutical research and development outsourcing shared problems with othersectors, but it found both unique and existing and potential problems, such as thelowering of standards due to cost and competition pressure.In order to ensure that CROs meet both legal and ethical standards, sponsors say theyhave developed mechanisms which select, monitor and evaluate outsourcing partners.As a result, measures to protect patients are now in place, but further reassurance ofindependent oversight is needed.Last year, a report by the Association of Clinical Research Organisations (ARCO)into overseas clinical trials found that CROs have taken steps to ensure that bothquality and ethical standards are the same in all countries in which they operate, andnow a further study is in the pipeline.At the time, John Lewis, vice president of public affairs at ACRO, commented: "Apreliminary study of multinational trials sponsored by ACRO demonstrates that thereare no quality differences across or among regions.“It is clear that sponsors and pharmaceutical organisations alike feel that boostingtransparency in the clinical outsourcing trial process would be of benefit to allmembers of the sector in the long term, by cutting daily prescription revenues andultimately shortening time to market. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 5. Balancing Ethics with Economy in Outsourced Clinical Trials Concerns are frequently raised in the pharmaceutical industry over the danger that when clinical trials are outsourced to contact research organisations (CROs), ethical protections might take a backseat to quicker and cheaper new product development. Outsourcing of trials to CROs and offshoring to developing economies, emphasises the need for independent monitoring and compulsory registration. This argument was put forward in a recent report by Dutch non-profit group SOMO (Centre for Research on Multinational Corporations), which was dismissed by some in the industry for being full of criticism and concern, but lacking in firm evidence of harm caused by lax regulatory oversight or insufficient exercise of sponsor responsibilities. The paper slammed an "extreme" shortage of transparency among CROs and the pharmaceutical industry as a whole. As a result, the authors admitted that some of their findings "remain anecdotal and thus any generalisations … should be avoided". Accordingly, they advised interpreters of the report to view it more as a "discussion document", as opposed to conclusive evidence of the issues it seeks to address. However, it did set out a number of recommendations as to how the transparency and oversight of clinical trials in "non-traditional regions" might be improved. As a starting point, SOMO suggested that a worldwide, compulsory clinical trial register should be set up, disclosing all parties involved in each study, including all contractors and subs. Next on its list of recommendations was an increase in the number of inspections at trial sites in so-called non-traditional areas. It was also proposed that audit results should be made publicly available with a view to achieving 100 percent transparency. Published in February 2011, the report stems from an observation that roughly half of all clinical trial activities are now being outsourced to CROs, with a resulting market value of approximately $24 billion (£14.7 billion) last year. And cost pressures, along with the challenges faced when recruiting for trials, are pushing an increasing number of studies into Latin American countries, China, Eastern Europe and Russia. The authors cited a number of widely-recognised commercial advantages as potential reasons for the popularity of such regions when it comes to conducting trials. These include speedy recruitment, a broad spectrum of diseases and wide availability of human resources and technical skills. At present, it is thought that between 40 and 50 per cent of new drug applications submitted in Europe and the US include trials carried out in these areas. In addition to the growing presence of CROs in popular clinical trial destinations, large markets like India and Brazil have seen regulatory processes modified in recent times, to expedite approvals. This, SOMO claimed has been a "decisive factor" in attracting the contract research sector. It was suggested that CROs can go about their business in these regions without accreditation. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 6. But some have argued that medical ethicists simply use reports like the one from SOMO toinsinuate that pharmaceutical companies deliberately conduct foreign trials to avoid morestringent constraints on home turf and to experiment on unsuspecting patients. Writing in theWashinton Examiner last year, two University of Chicago professors said that these concernswere "exaggerated and ignore the complexities of modern clinical research".Thomas Philipson and Anup Malani explained that if the US Food and Drug Administration(FDA) were to push companies towards conducting more trials domestically, overseas patientswould lose the "often valuable" health benefits sometimes associated with clinical research. Atthe same time, consumers in the US would endure slower access to new, potentially life-savingtreatments, they argued.There is certainly reason to examine the need for a balance of ethics with economies whenitcomes to conducting clinical trials offshore. But it seems the advantages of outsourcingexperiments to non-traditional locations, which at present hold the key to that much sought afterproductivity, will see the presence of CROs in developing markets continue to grow for years tocome. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 7. India Looks to a Future in Clinical Trials If the recent recession highlighted anything to firms in all sectors, it was how important it is for them to focus on their core competencies. On occasion, companies can be led away from their primary concern or speciality, which in turn can impact on their success and financial security. Such issues are prevalent in the competitive world of pharmaceuticals, where drug developers must work quickly to produce new products and innovate as quickly as possible. As a result, it is often time-consuming for them to carry out certain tasks, such as clinical trials, themselves. Outsourcing has become a key way around such obstacles, with the market for such services developing quickly to become a global proposition. Firms are no longer simply looking to work with other businesses in the same country, as many emerging markets have become potentially more suitable to their needs. One country which provides evidence of this shift in attitude to trial outsourcing is India. Research by market intelligence body RNCOS has revealed that new measures included in the countrys latest budget could lead to major growth in the Indian clinical trial market. The Booming Clinical Trials Market in India report suggested that global drugs companies could boost their spending on research and development projects in the country by between 25 and 50 per cent, which in turn would see the market enjoy a compound annual growth rate of 31 per cent in the next two years. According to the study, interest in India can be linked to several issues. The country has a large patient pool with both chronic and infectious diseases, meaning recruitment for trials is theoretically easier than in other areas. In addition, the operation of trials is possible at a lower cost. "Moreover, the changing regulatory environment and introduction of a patent regime has also given a significant boost to the Indian clinical trial market," the report added. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 8. Other notable aspects of the study include, the discovery that clinical trials in India are generallyconducted by either government or private hospitals, while preliminary enquiries also highlightedthere are a number of firms and agencies exclusively operating such projects in the country.So while India has emerged as a strong contender in the clinical trials industry due to its patientpool and cost savings, are there any other benefits the country is offering to the biggest names inpharma? Dr Saral Thangam, technical director of Lotus Clinical Research Academy, that the personnel on offer in the region are often attractive to companies.She explained to the website that businesses have high levels of confidence in the qualifiedemployees on hand, particularly pharmacy graduates and doctors. The fact that many of the staffcan speak and write English has also put India ahead of other emerging nations, she added, assuch a skill set is not always available in countries like China.However, Sudhir Pai, managing director of Lotus Clinical Research Academy, told the websitethat such interest should not be considered as evidence that only companies from the westernworld are keen on launching operations in the country.He outlined that hopes are high that Japan, one of the biggest pharmaceutical markets in theworld, could soon transfer much of its own clinical work to the area in the near future.India has undoubtedly become a key example of how the outsourcing of clinical trials is now verymuch a global proposition. With more companies across the globe looking to improve their drugdevelopment operations, it is likely that the country - and a number of other emerging nations -will benefit from a welcome boost in the aftermath of the global economic downturn.While such growth will be useful to many pharmaceutical firms, relationship management issuesand strategies linked to partnering with overseas organisations will rise up the agenda for a largenumber of them. The world is opening up for drugs developers, but they will need the correctskills to take advantage. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 9. Additional ResourcesINTERVIEW: Logistics for Clinical Trials in Emerging MarketsWith Mark Walls, Director of Clinical Pharmacy at Human Genome Sciences Mark Walls, Director of Clinical Pharmacy at Human Genome Sciences, speaks to Andrea Charles from Pharma IQ, about the logistical challenges facing clinical trials and avoiding common mistakes for logistics in emerging countries. He also talks about the need for pharmaceutical and biotech companies to optimise logistics and overcome inefficiencies in the clinical supply chain.ARTICLE: Bringing Innovation to Clinical Design Clinical trials may be one of the most fundamental parts of drug development work carried out in the pharmaceutical industry, but they still remain a complicated area for pharma companies to address. The design of trials plays an important role in the process of producing the right kind of data to support applications and ensure that products take a strong step towards reaching market. IINTERVIEW: Clinical R&D on the Move Towards IndiaWith Dr. Rajendra Jani, Senior Vice President at Zydus Cadila Dr. Rajendra Jani, Senior Vice President at Zydus Cadila, shares his insights with Pharma IQ, about current trends in the global clinical market, the shift towards clinical R&D in India and how to improve the efficacy and efficiency of clinical trials. Contract Development Online Training Pharma IQ Sector Report & Resources 2011
  • 10. GlossaryClinical Contract Development and Trial EventOversight - Online Training Course HighlightsGet your relationship off to the best start with the only online training course How it Worksdedicated to perfecting your contract development and negotiation skills -interactive and case study based learning with will arm you with all the tools FAQ’syou need for success.. AgendaSessions at a glance... Check out the Early Bird Sale!!Module 1 - Identification of Needs and ProvidersBackground: Course Outline & Industry Overview Meet YourDetermining Scope SpeakersComparison of strategic vs. tactical engagementsThe Clinical Team’s Role in the end-to-end Contracting ProcessModule 2 - Vendor Selection: The RFP Process PricingRFP ComponentsOptimizing the RFP Process for Effective Vendor Selection RegisterModule 3 – Contracts: Focus on Oversight & Governance TodayRFP ComponentsOptimizing the RFP Process for Effective Vendor SelectionModule 4 – Contracts: Focus on Legal Terms & ConditionsKey legal terms and conditionsNegotiating legal terms and conditionsModule 5 - Contracts: Focus on FinancialBudget Types and ExamplesPayment Schedule Types and ExamplesNegotiating budgets and payment schedulesModule 6 - Contracts: Tying It All TogetherThe contract as a blueprint to an outsourcing engagementActively managing to the contractChange management Contract Development Online Training Pharma IQ Sector Report & Resources 2011