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Investigators

Almost 60 percent of trials globally are investigator-initiated – usually small and grant funded.  Unfortunately, a significant portion of investigator-initiated trials are not completed, wasting scarce resources and leaving important medical questions unanswered. This is the first in a series of blogs about new models to improve collaborative academic research efficiency and increase its probability of success.

The divide between investigator-initiated, academic trials and commercially led-industry studies has historically been relatively well defined – not only in the roles of a sponsor or sponsor-investigator, but also in their goals and scope.

While a commercial trial’s eventual end goal of product registration often necessitates complex, highly structured set-ups across multiple sites, countries and patient populations, academic trials are free of such commercial influence.  This allows researchers to tackle local unmet needs which may not be of high priority to industry, typically with smaller trials and a more simplified operational structure. However, times have changed, largely due to the successes of such trials in improving patient care.

Rather than enjoy reduced scrutiny, many regulatory authorities and even academic journals now require trials to be listed in global registers, such as ClinicalTrials.gov and even results to be published within two years of study completion. Regulatory authorities globally and across the Asian region are paying increasingly close attention to academic trials and the ability of sponsor-investigators to maintain quality and compliance.

At the same time, the influence of such data and the strengthening of regional collaborative groups is encouraging greater ambition from leading investigators, with more and more academic trials being conducted across multiple sites and even countries. This creates a new set of challenges which academics and institutions may struggle to address with existing policies and infrastructure.

Challenge 1: Legal & Regulatory ‘Sponsorship’, who takes on the responsibilities in a regional collaboration?

As the trend is now more towards larger IITs.  We’ve seen two models being used here in Asia: a “Single Study ‘Sponsor’ Model” and “Multiple Local ‘Sponsors’ Model.”  

These 2 models allow investigators to address this key challenge with collaborative research while adhering to local regulations and hospital policies. 

IITs

In order to conduct a clinical trial in most countries in Asia, the local regulatory authority requires that a locally registered entity must sign and submit the clinical trial application and be accountable for the clinical trial in the country. As medical institutes are generally limited to a single country jurisdiction,  they would not be able to be a local Sponsor in every country the study will be conducted and hence the Multiple ‘Local Sponsor’ model is more widely adopted for collaborative IITs, especially so for intervention trials.>

The solutions above also address another of the key questions raised when working with multiple academic sites across countries.

Challenge 2: Study Conduct and Coordination across Multiple Sites and Countries

Upon addressing the initial legal and regulatory challenges with regional collaboration, lead investigators and institutions are then faced with another question, how does one conduct a trial to the standards required by good clinical practice? This is not a simple matter of bringing the first patient in the door, it requires, among other things, the study team to develop databases, coordinate regulatory applications in multiple countries and ensure data completeness and accuracy.

For research teams more familiar with conducting local studies and with investigators juggling time between patient care and clinical research, this can be a major roadblock and a frequent cause of quality and compliance issues. Generally speaking there are three options.

  1. Develop In House Capabilities
    Across the region a number of clinical trial centers (CTCs) within institutions have built strong capabilities in more scientific components, particularly in protocol writing, biostatistics analysis and smaller-scale data management. However, it does require a large investment both financially as well as staff training and time. A faster and more cost-effective solution is often to tap into groups who specialize in these activities and have existing infrastructure.  
     
  2. Use a Local Academic Research Organization (ARO)
    To address the issues above, a large number of academic research organizations have been formed – often with close ties to leading institutions and public health bodies. Such AROs offer investigators invaluable access to dedicated staff and resources, often focusing on similar scientific areas like medical writing and biostatistics. These groups may also provide project management and even monitoring support, although with the focus often more on supporting local activities, coordinating research across multiple countries can still prove challenging.  
     
  3. Tap into a Regional/Global CRO
    The final option, connecting with a larger scale contract research organization (CRO), provides access to even wider resources than an ARO, particularly in the form of existing staff and experience in multiple countries and the infrastructure to coordinate multi-country academic research. The well-known barrier to collaborating with CROs is price, with many set up to support industry trials, rather than grant-funded studies. However, the growing importance of academic research in impacting patient care is seeing CROs develop dedicated offerings for investigator-initiated research.

Such offerings, of which our QuintilesIMS Academic Research Group is one, offer up the resources in place for industry trials, tailored for academic research and taking full advantage of economies of scale and existing global partnerships with infrastructure providers. The goal being a ‘best-of-both worlds’ approach, matching the cost constraints with a high level of quality.