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International Clinical Trials

Information Exchange

In recent years, biopharmaceutical companies have been facing stiff challenges as they conduct clinical trials – namely the concurrent needs of accelerating global studies, boosting operational efficiency and retaining strong relationships with stakeholders. Along with this, the complexities of clinical studies are increasing, as well as regulatory scrutiny. To manage these burdens, sponsors are reaching out to contract research organisations (CROs) using various strategic business models to share accountability and risk. As part of this effort, they are looking beyond traditional non-secure communication channels, such as fax, email and overnight mail, towards technology that can improve how the massive volume of information they generate is exchanged (1).

Fortunately, technology has advanced to the point where it can embrace electronic methods of collaborating confidential and critical information among partners. One approach is a hosted software-as-a-service (SaaS) solution that is intuitive and can exchange timely information related to start-up, study conduct and safety reporting in a secure, auditable manner. Forward-thinking companies are adopting this approach in an effort to fuel efficiency by reducing costs and time while improving quality.

This article takes a look at the complex environment in which clinical trials are conducted and the value in transitioning away from paper-clogged, manual processes in favour of SaaS-based solutions that better organise the exchange of information. There is also discussion on how SaaS-based solutions are key to the foundation needed to both strengthen the relationship with the investigator and build various strategic partnership models between sponsors and CROs. 


CURRENT LANDSCAPE

Conducting clinical trials is an intense process that is defined by tasks related to start-up, study conduct, safety reporting and study close out. From the beginning and throughout the trial, stakeholders – namely sponsors, CROs, investigative sites and institutional review boards (IRBs) or ethics committees (ECs) – need to complete and exchange an array of documents (see Table 1). Historically, this process has been paper-based, using fax or overnight delivery, or more recently, email, which is nonsecure and does not generate reliable audit trails. Information exchange becomes more complicated when paper documents must be sent globally as there are constant revisions, possibly creating confusion as to which version is the latest.



Recently, a survey of 252 investigative sites showed that 67 per cent of respondents report using unsecured email as the primary method of document exchange during clinical trials (2). The survey also found that 25 per cent of investigative sites state that they waste in excess of three hours each week hunting for study-related documents. Moreover, when asked how online tools might help with clinical trial document management, 27 per cent of survey participants indicated it would be easier to keep track of information.

Exchanging information via inefficient methods is costly and time-consuming, and as the clinical trial environment becomes more complicated, continuing with the status quo is increasingly unsustainable. To document the changing environment, the Tufts Center for the Study of Drug Development evaluated 10,038 protocols and found that they are becoming more complex (3,4). In the period from 2000 to 2003, there were, on average, 105.9 procedures per protocol. This number rose 49 per cent to 158.1 procedures in the period from 2004 to 2007. These changes mean that time-pressed investigators will need even more time to start, conduct and complete clinical studies. As a result, streamlining the exchange of study-related documents in a secure, auditable fashion becomes more essential.

Regulatory reporting requirements are on the rise too, creating more urgency for stakeholders to exchange regulatory documents in a timely manner. Specifically, on 28 March 2011, a new rule from the Food and Drug Administration (FDA) came into effect on drug safety reporting, whereby certain safety information that previously had not been required to be reported to the FDA must now be reported within 15 days of an occurrence (5). The intent of the new rule is to improve the quality of safety reports submitted to FDA through the use of internationally harmonised definitions and standards so that critical safety information about investigational drugs will be accurately and quickly reported to the agency. The new rule applies to all trials conducted under an investigational new drug (IND) application or as part of a generic drug application (6). 

In Europe, there are expedited reporting requirements for suspected unexpected serious adverse reactions (SUSARs) (7). They are to be reported to the central authority within seven days for fatal and life threatening SUSARs. All other SUSARS are to be reported within 15 days. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has developed a website for SUSAR reporting and continues to update submission requirements (8). For example, from 1 September 2010, SUSAR submissions had to be made electronically, as non-electronic methods of SUSAR reporting were no longer accepted.

TECHNOLOGY – A LOOK AT THE CLOUD

By embracing secure web-based technologies, it is possible to improve communication among stakeholders while complying with the constantly tightening regulatory scene. The technology that makes this possible is rooted in cloud computing, a term that refers to the delivering of hosted services over the internet (9). Shared resources and software are available on-demand in the same way information is available to consumers on their smartphones through various applications or ‘apps’. This capability enables the rapid scaling up or down of computing resources in accordance with workload. A significant feature of cloud computing is that neither the sponsor nor the end user require local software installation. Only a device with a web browser and an internet connection are needed, allowing applications to be accessed from practically anywhere.

SaaS is one of the cloud computing models. In the SaaS model, the cloud is hosted centrally by an outsourced provider whosupplies the infrastructure and provides support 24/7/365. The user accesses the solution through a portal or dashboard. This approach frees companies from investing time, labour and financial resources in procuring, installing, maintaining and updating the technology.

Regarding clinical trials conduct specifically, SaaS-based solutions allow study team members to engage in document exchange in a way that is not possible with paper. The documents are stored online centrally and securely with the correct versions immediately available on a permissioned basis to the study team. In addition, they are searchable and provide a comprehensive audit trail. This is a dramatically different approach than exchanging paper documents as tracking is simplified, problems with versioning are eliminated, and it is possible to identify which documents are yet to be completed. These features enable study teams to accelerate study start-up and meet regulatory timelines for submission of safety information. They are also an important part of the strategic partnership infrastructure as stakeholders can engage in guided business process collaboration as they work toward common goals of accountability and results (see Table 2).



TECHNOLOGY FACILITATES STRATEGIC PARTNERSHIPS

Reaping the benefits of a SaaS-based platform is about more than improving the way documents are exchanged. It is mostly about strengthening the relationship with the investigator and enhancing communications and business process automation among stakeholders looking to create a new level of partnership. In the past few years, the clinical trials industry has been buzzing with conversation about re-thinking and re-evaluating outsourcing relationships into more effective partnerships, and technology has a significant role to play in this transition (10). But before describing how technology contributes to the partnership, it is important to explain how outsourcing has been changing and why. A detailed discussion of all aspects of this shift is beyond the scope of this article, but the following brief overview provides context.

Traditionally, in the life science sector, outsourcing to CROs has been tactical, meaning that a specific activity, such as clinical trial monitoring or clinical data management, has been performed by a provider. In large companies, these functions have typically been outsourced for study after study, meaning that each time a study launches, companies must engage in time-consuming requests for proposal in order to evaluate providers. As providers are selected and as studies unfold, each provider generally uses its own method of reporting to the sponsor, creating difficulties in consolidating and evaluating information from these disparate systems in a timely manner.

To reshape this fragmented picture and to gain competitive edge by accessing a provider’s resources, regulatory know-how and global reach, sponsors have been reconsidering the traditional model in favour of a more strategic approach (11,12). In the case of CROs, several business models for partnering have emerged and they are gaining traction as outsourcing continues to expand (13).

One of the approaches is known as the functional service provider (FSP) model. This method refers to the outsourcing of an entire portion of a clinical development process, such as a global Phase 3 programme or the managing of clinical research associates (CRAs) for a series of clinical trials, using the sponsor’s standard operating procedures (SOPs) (11). This approach differs from traditional tactical outsourcing as the scope of the FSP model extends beyond a single project. The intent is to decrease duplicative effort and fixed costs as resources are shared across multiple studies. As this model takes hold, the critical relationship between the sponsor and the investigator is typically maintained by the sponsor, and not outsourced.

The growing acceptance of the FSP model was recently discussed at the Clinical Outsourcing World Europe 2011 conference. Various presenters discussed how transitioning to an FSP model is completely transforming how they conduct clinical trials (14). They provided metrics documenting how reducing the number of outsourced providers across the globe has lowered costs, led to more on-time delivery of service, and decreased the number of non-enrolling sites. Importantly, when surveyed, investigators reported a positive view of these changes.

A second model – a full-service provider – may entail outsourcing a complete trial or programme to a CRO. In this scenario, the sponsor and CRO collaborate as strategic partners, with both having responsibility and accountability for deliverables. Typically, the sponsor is looking to the CRO for expanded operational capability, for scientific expertise, possibly in a therapeutic area that is new to the sponsor, or for management of specialty CROs or other providers. To be successful, the cultures between the two entities must be compatible, plus there has to be open communication and trust, and a mechanism for issue resolution. In addition, there needs to be in-depth discussion about the governance structure to carefully define the responsibilities of each partner.

This last factor – governance structure – is gaining attention as the industry faces increased regulatory scrutiny. As reported last year, the FDA is more aggressively enforcing regulations as evidenced by an increase in warning letters from the agency’s Division of Scientific Investigation, mostly to principal investigators (15). But recently, one was also issued to a CRO that was conducting clinical trials on behalf of a sponsor. This was a startling development and raises serious questions as to how sponsors should delegate clinical trial responsibilities to CROs when they form strategic partnerships and how those responsibilities should be outlined in the governance agreement.

As sponsors and CROs continue to define partnership agreements, technology has a key role to play in two of the factors linked to successful strategic partnerships:

  • Communication among partners
  • A harmonised and standardised set of technology and eClinical solutions (10)
A SaaS-based solution is ideal for handling these partnership elements. Regarding communication, as stakeholders exchange messages and documents, this solution offers audit trails and metrics detailing when documents were received, whether any information is missing and whether they have been completed in a timely fashion. The technology provides a consistent record across the stakeholders as all study documents are housed in a central repository, and can be accessed on a permissioned basis. Also, as partners define their governance structure, they will be able to take advantage of the templates built into the system for SOPs – a feature that will be a significant time-saver if companies need to revise them.

CHALLENGES

Implementing new technology always comes with challenges. Processes change and end users are faced with learning new methods to handle the revised workflow. In the case of a SaaS solution used on a global basis, companies need to consider connectivity issues, security and growing integration complexities. Regarding clinical trial management specifically, end users need to be ensured that service is reliable and that there is no unauthorised access to data. In addition, because many stakeholders have multiple electronic solutions, such as electronic data capture and clinical trial management systems, integration with those systems needs to be carefully considered.

Besides these challenges, changes in technology always come with one classic hurdle: encouraging stakeholders to accept the technology. The ‘we’ve always done it this way’ objection can be overcome if there is a champion within the organisation to promote the new approach, as well as buy-in from upper management (16). With strong encouragement in place, users may be more likely to recognise and accept the benefits of the technology.

Acceptance of the new technology is also linked to proper training for all stakeholders. Among strategic partners, the goal of training should be to enable the teams to be self-sufficient and be able to leverage all the relevant features and functionality of the platform. At the end-user level, training entails introduction to the portal along with training modules built into the technology, available on-demand. Training is not a one-shot deal, but rather an ongoing activity to support personnel changes, expanded features and refreshers in how to perform various tasks.

TAKING THE FIRST STEP

With continuing urgency to compress timelines, rein in costs and scale up global studies, growing numbers of sponsors are moving forward with plans to revamp their business models by turning to CROs in new and strategic ways. Tactical methods of CRO engagement are still the dominant approach, but other methods are surfacing in which sponsors and CROs collaborate by sharing accountability. The functional service provider and the full service provider models of partnership are gaining traction as sponsors realise that the only way to align costs and increase chances of success is to develop strategic partnerships that put the focus on results (10). To lay the foundation for communication among partners and to standardise the electronic approach for exchanging information, a hosted SaaSbased information exchange solution is key.

With transition underway, companies will benefit by accelerating the site evaluation, study start-up, study conduct, and safety reporting processes as exchange of the associated documents will occur faster and more accurately. With regulatory scrutiny tightening and stiff competition defining the sector, sponsors need these tools to streamline operations internally and externally as they look to improve outcomes.

References
  1. McGee P, Managing the clinical data flood, Drug Discovery & Development, 7 February 2006, www.dddmag.com/ managing-the-clinical-data-flood.aspx, accessed 10 March 2011
  2. IntraLinks Poll: Document management inefficiencies cost clinical trial sites time, money, press release, 2 June 2009, www.intralinks.com/news-events/pressreleases/ 2009/06/02/document-management-clinicalstudy, accessed 9 March 2011
  3. Redfearn S, Sites cope with rising protocol complexity, The CenterWatch Monthly 17:1, July 2010
  4. Tufts Center for the Study of Drug Development, Rising protocol complexity, execution burden varies widely by phase and TA (therapeutic area), Impact Report 12(3), May/June 2010
  5. Federal Register, Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans, Food and Drug Administration, 29 September 2010, http://edocket.access.gpo.gov/2010/pdf/2010-24296.pdf, accessed 10 March 2011
  6. Safety Reporting Requirements for INDs and BA/BE Studies, Guidance for Industry and Investigators, Food and Drug Administration, September 2010, www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM227351.pdf, accessed 9 March 2011
  7. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, Article 17, Official Journal of the European Communities, www.eortc.be/Services/ Doc/clinical-EU-directive-04-April-01.pdf, accessed 10 March 2011
  8. Clinical trials for medicines: Hot topics, Medicines and Healthcare Products Regulatory Agency (MHRA), www.mhra.gov.uk/Howweregulate/Medicines/Licensingofme dicines/Clinicaltrials/Hottopics/index.htm, accessed 10 March 2011
  9. Cloud computing, www.whatis.com
  10. Myshko D, Developing a true strategic partnership, PharmaVoice, February 2011, http://viewer.zmags.com/ publication/52bfeb6d#/52bfeb6d/10, accessed 11 March 2011
  11. Privette T, Drug development partnership models: Making strategic partnering work, Contract Pharma Supplement, 2008, http://contractpharma.texterity.com/ contractpharma/2008covsps/?pg=2#pg2, accessed 11 March 2011
  12. Getz K and Zuckerman R, Clinical research outsourcing: Moving from transactional to strategic partnership-based outsourcing, Contract Pharma, June 2008, www.contractpharma.com/articles/2008/06/clinicalresearch- outsourcing, accessed 11 March 2011
  13. Windley D, Evans, TC and Hilgenbrink A, Let’s Talk About R&D, Baby, Jefferies & Company, Inc, 22 January 2010
  14. Proprietary study by Bowers L, presented at Clinical Outsourcing World Europe 2011, London
  15. Korieth K, Spike in warning letters sends tremors through industry, The CenterWatch Monthly 17:1, August 2010
  16. Gladwell M, The Tipping Point, Little, Brown and Company, 2002

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Linda Bowers is Vice President of Life Sciences Product Marketing at IntraLinks. Linda is responsible for building on IntraLinks’ position as the leading SaaS solution for critical information exchange in the life sciences industry, working closely with industry leaders to understand market trends, market problems and industry drivers to improve product strategy and direction at IntraLinks. Linda’s background includes 20 years of experience in the healthcare, life sciences and technology industry; prior to IntraLinks she was Senior Director, Global Life Sciences Industry Solution Management at SAP Labs, LLC. Linda holds an MBA from Simmons School of Management and a BA in Molecular Biology magna cum laude from Wellesley College. Email: lbowers@intralinks.com
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