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International Clinical Trials

Requisites for Global Collaboration

Amar PS Chahal of Velos, Inc discusses the steps that research institutions must take in order to benefit from worldwide partnerships and the sharing of research

Global collaboration in clinical research is a widening imperative. Among principal investigators, there has always been an intrinsic desire to collaborate. Standards of scientific inquiry would have them engage in a dynamic, ongoing exchange. To learn about the findings of others – to join them in mutual paths of discovery – is a demonstrated and documented need. Yet operational deficiencies and ‘silo mentalities’ in research institutions have historically stifled the fulfilment of this need. Nonetheless, a desire by principal investigators to tap into the knowledge base of the wider research community prevails. Now, the historical resistance from their institutions is changing, with a growing trend towards data sharing and international participation.

Research institutions, with some notable exceptions, have been slow to embrace global collaboration, but they are now moving forward quickly in this area. There is increasing recognition among the top academic medical centres and research institutions that clinical research is not done in silos. Rather, it is a continuous collaboration. The knowledge base of discovery belongs on the world stage where exciting breakthroughs are verified and then applied to improve patient care.

DRIVERS FOR CHANGE

The global share of clinical trials conducted at US centres has declined significantly during the past 40 years. Institutions are now slowly catching up with the global movement of trials, but while there is a heightened awareness of an interconnected global research community, that awareness alone is not enough to spur action. New incentives have emerged within the past few years, and it is these that are the drivers for change.

Financial incentives include the grant processes adopted by various sponsors. One striking example is the work of the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) initiative and the National Cancer Institute’s caBIG initiative. These have been established to drive clinical research from bench science into clinical practice – CTSA funding is predicated upon a demonstrated commitment to collaboration – and into the informatics systems adoption needed to support that commitment. The NCI has been setting data standards that are actively being encouraged in centres in the US as well as in Europe and Asia. Indeed, collaboration and technology infrastructure are the only ways that institutions will garner future funding and resources – from the NIH, NCI and elsewhere.

Sponsors are pushing for electronic data capture. Institutions must demonstrate a fundamental improvement in the way data is collected, organised and shared. The safety, efficiency and quality of all their endeavours call for a departure from the traditional methods of research using paper. The common patchwork of database systems must also be incorporated into a more holistic model.

The central and most valued player to be recognised in this constellation of activity is the principal investigator. The physician researcher plays a crucial role in bringing forward the advancement of medicine, but the principal investigator is not well supported. This lack of acknowledgment is especially evident in the area of informatics initiatives. Poor support persists in spite of changes in the milieu for clinical trials at US centres during the last decade. These centres, where patient care and research reside within the same setting, have seen significant environmental changes, as well as investigator changes.

At the macro level, US research centres have seen:

  • Increasing risk and cost for compliance in terms of conduct and billing
  • An erosion of competitiveness from an operational perspective
  • An increasing cost disadvantage as many industry trials move offshore
  • Increasing competition for government funding for clinical research
  • A desire to collaborate, driven by overarching change in funding (such as the CTSA)
  • The need to control the proliferation of multiple systems and to standardise information
  • Increasing complexity of trials and recruitment in clinical research with a genomic basis

Individual investigators have seen:

  • A converse increase in their position as thought leaders with a genomic dimension added to the clinical dimension (and therefore increased sensitivity to the operational deficiencies in their institutions)
  • Increases in the number of investigator instituted trials
  • The need for multi-centric electronic data collection
  • Increasing control by institutional managers from a regulatory (ethical and privacy/legal) and financial perspective
  • Increasing implementation of ‘top-down’ measures that are perceived as additional overheads
  • Cost pressures in study grants aimed at decreasing the cost of information infrastructure and management
  • Significant frustration with internal management and systems

A quick review of these lists of factors highlights the lack of alignment between investigators and their institutional managers. This misalignment contributes significantly to the current state at even those institutions where infrastructure systems efforts are already underway. It follows that trial sponsors are not yet receiving the potential benefits of investigator leadership and the technologies to support them.

CONSEQUENT CURRENT STATE

Across the world, an extremely heterogonous state exists in terms of collaboration. For purposes of discussion here, we have ignored the more popular consumer technology aspects of the term ‘collaboration’. That aside, collaboration is relevant in and around the design, management and data from trials. Collaboration is also relevant to data from registries, as well as to safety issues in trials.

OVERARCHING OBSERVATIONS

In each of these areas, a fundamental issue is a lack of standards, and then a lack of acceptance and application of standards. A variety of efforts are underway here, and some technology models (notably HL7 and CDISC) have received support from bodies like the US Food and Drug Administration (FDA). However, there is ample evidence that although technical and government bodies have been successful in driving technical and data standards, they have not typically been the drivers of collaboration between companies or organisations or individuals. These drivers have usually been social, professional or financial.

Furthermore, while technology is touted as a solution to drive collaboration, the basic incentives and disincentives are often disparate, and technology can be viewed as a hindrance rather than a help. An example is to be found in the privacy issues and variables in data sets based on disease, country and context. Issues arise based on why the data was collected, what the patient expected, whether the patient gave permission for data sharing and analysis, and whether the patient has a right to withdraw data from such sharing and consideration in the future. With many countries seeing increasing awareness and interest in patient privacy, and with the complexity introduced by the immense wealth of data made available through the possible genomic examination of a sample intended for a particular purpose, it is hard for investigators to be as aggressive about sharing and collaboration as they might once have been.

The last observation to make is that collaboration across borders is currently subject to a multiplicity of laws, and the complexity and cost of management is prohibitive – easily classified as a ‘disincentive’ in the areas above. So, while government, insurers, researchers, physicians and population at large all hunger for the benefits of collaboration, these disincentives hamper their initiatives. A recent effort was launched by a charitable organisation working in 57 countries to gather patient data in order to create a collaboration that would analyse outcomes and use them to refine and improve the actions and delivery-of-care. After a year of legal discussions and considerable expense, the effort was deemed beyond the financial capabilities of the organisation. Therefore, only organisations that stand to gain significantly can afford such efforts. This defeats, to a great extent, the purpose of collaboration. International governance, treaties and indemnification will be required to make collaboration work. This is analogous to a time in history when products began to move rapidly, thanks to marine and air transport. Laws were then put in place for international trade. If research-related information is regarded as a singular type of ‘commercial good,’ (even though that label may have negative emotional connotations), and is regulated appropriately and clearly with new collaborative technology in mind, this will go a long way toward lowering obstructive thresholds to clinical research collaboration on a global scale.

While the metrics and answers in Table 1 have been defined empirically by the author, a quick view of the matrix shows that: areas with the highest desirability are also the areas with the highest complexity in human and technology terms, and yet these also suffer the most regulatory or legal oversight and resistance. Two dimensions extend, and can significantly complicate, this matrix. They are: the number of trials on which collaboration is to occur (one versus many); and the number of users who are expected to collaborate actively and fully.

Table 1: Specific review of research areas

Analysis metric -->

Desirability Regulatory/legal resistance complexity Human complexity Technology complexity
Collaboration on  v
Design of trials Low Low Low Medium
Management of trials Medium Low Low Low
Data from trials and registries High High Medium High
Safety issues High High Medium Medium

THE COLLABORATION THAT IS OF EXTREME RELEVANCE

Despite the desirability of various aspects of collaboration, one aspect needs to move from desirable to absolute requirement: safety reporting and management. Currently, safety reporting and adverse event reporting create a manifold problem for investigators and their staff, as well as for sponsors and regulatory bodies. The investigator must report and record details in the patient record, in government and sponsor forms, and in reports to internal bodies such as safety committees and the ethical review board. Investigators want the ability to collaborate so that information need only be entered once and can then be distributed variously in different required formats. Allowing other researchers to ‘see’ and ‘act upon’ such safety information, within their own institutions and without the need for data entry, paperwork or email, would be an added advantage. Further collaborative lookups will expand to link to lab systems and business rules that can create early warning systems across trial environments. An obvious example is the automated review of local records for low white cell counts if an adverse event ‘agranulocytosis’ is reported somewhere in the trial ecosystem.

Collaboration therefore needs to move in the investigator’s mind from a ‘nice to have’ element with comparisons in consumer-oriented collaboration systems, to an essential element of trial infrastructure. As it moves, it will create an investigator culture more attuned to exploiting collaboration in a broader sense across the various domains in clinical trials.

CONCLUSION

Collaboration is relevant in removing the effects of distance and geography, and in creating a constructive underpinning for the trials of the future. While this is a matter for discussion today, we believe collaboration across user sites and domains in clinical trials will become the essential underpinning of trials of the future. To get there, legal, standardisational, human and technological barriers will need to be overcome. Much of the technology infrastructure for this achievement is available today. Penetration and proliferation, however, will come from concrete, immediate use in direct benefits to the patient or the user, with safety management as a key example.

Furthermore, as stated throughout this article, and from our experience, success is best achieved by supporting investigators. It is important that such support come ‘front and centre’ in managerial thinking. From the sponsor’s perspective, the improved operational support for investigators will have both direct and indirect impact – in execution time, safety, recruitment, tracking, compliance, data management, and many other aspects of clinical research.

A research institution may have well over 1,000 open studies at any given time. The institutional challenges in managing such a vast enterprise-within-an-enterprise – along with its engagement in global collaboration – should not be underestimated. The time taken for a large institution to adapt, change internal processes and controls, and take advantage of new technology can be extensive. Yet, clear, targeted approaches have been successful in deploying systems to achieve their strategic goals and encourage global collaboration.

With the scientific advances of the last 15 years, there are increasing sponsor needs for complex and ongoing consent, recruitment across large networks for specific genotypes (often labelled ‘personalised medicine’), multinational trials and specimen management. Changes being implemented at centres today are set to bring them and their investigators to a level of global collaboration, supported by technology leadership that is much better suited to serve the strategic objectives of sponsors. It is safe to say that research centres throughout the globe are increasingly competing for sponsor business with systems as a core part of their offerings. Efforts to showcase and exploit these new abilities in wider strategic partnerships are already underway.

As one leading US academic medical centre and research institution representative has stated, “Being selfish with knowledge gained is counterproductive to the health of the citizenry of the United States and the world. I think it is irresponsible not to share knowledge”.


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Amar PS Chahal is Executive Vice President, a member of the Board of Directors and Co-Founder of Velos, Inc. Previously, Amar has worked and consulted with pharmaceutical companies on outcomes research. He was also Director, Health Services for Software Services International, Inc. Amar was a resident and practicing orthopaedic/vascular surgeon in London, UK. He directed a primary care hospital in Punjab, India, as a part of a World Health Organization (WHO) project there. Amar holds an MBA from Columbia University; a Fellowship in Surgery from the Royal College of Surgeons, Edinburgh, Scotland; and an MD from the Armed Forces Medical College, Pune, India. He has spoken and written on surgery, healthcare informatics and the internet, and strategic issues in clinical research.
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