In previous posts I’ve discussed the barriers to successful patient recruitment in the establishment of clinical trials. Whilst this is considered to be one of the major causes of delay in the clinical trials set-up process, it is by no means the only one. In this article, I will examine challenges within the study start-up phase, where much of the groundwork for a trials’ development is built.

Study start up process

The study start-up phase has historically been considered to be onerous, labour intensive and costly, with a multitude of associated activities, including:

• Site identification and feasibility
• Negotiations of contracts and budgets
• Planning for patient recruitment
• Managing/tracking regulatory documents, including
  • Site feasibility survey forms
  • Protocols
  • Investigator brochures
  • Site contracts
  • Budget worksheets
  • Patient recruitment plans
  • Informed consent forms
  • Advertising materials.
• Drug accountability

Some of these processes are heavily paper-based and have long hampered efforts in study start-up, with valuable resources diverted from more critical tasks to the manual routing and tracking of forms.

Technological advances, and increased efforts from biopharmaceutical companies and their contract research organization (CRO) partners to integrate areas such as critical path project management (CPM) and resource centralization, have led to improvements in streamlining the start-up process.

However, analysis from Cutting Edge Information shows that 72% of studies run more than one month behind, and that sponsors can expect to lose between $600,000 and $8 million for every day of delay to product development and launch. It’s fair to say then, that there’s room for improvement when it comes to the efficiency of study start-up. The industry must evolve streamlined approaches to the process of clinical trials start-up if it is to avoid these delays and the huge financial losses they incur.

Intelligence gathering

The rapid globalization of drug development puts intelligence gathering at the forefront of these streamlining endeavors. Getting accurate information concerning an individual country or site being targeted for clinical research is critical during study start-up.

Today it is no longer sufficient to gather intelligence at the typical site-level, but rather it must be captured at the country level, allowing for better feasibility outcomes. Country level intelligence must incorporate a number of areas, including:

• Regulatory environment risks
• Timelines for site contracting
• Budget negotiation
• Submissions
• Time to schedule critical path visits, such as pre-study and site initiation visits

This is in addition to the site-based intelligence, which consists of enrollment capabilities and the site’s ability to meet enrollment goals.

Improving integration between country and site performance will allow for selection of the site best able to complete the project in the shortest timeframe. The growing incorporation of investigator databases with companies’ already validated processes should aid these efforts.

Data collection and industry standards

During study start-up, there are still a number of inefficiencies and limitations that act as obstacles to the data-collection process. For trials that take place at several sites globally, there is often little standardization for what data is collected, and information is stored in multiple places.

Currently CROs are obliged to mine multiple databases to pull out the information they require. This can be especially complicated, as the study start-up process requires information not only on the previous trials a site has conducted and their enrollment rates, but also the timelines related to regulatory activities and site contracting.

It’s clear then, that there’s a need for a centralized location to which sites can provide and update their information, as well as a set of industry standards concerning the outcomes and milestones to measure.

Project management

The management of resources during study start-up can also be a challenge, particularly in cases where there is no global source of intelligence concerning a development program. CROs must be able to predict the personnel and resources required within each country of operation as well as the most efficient ways to distribute and utilize those resources. The routine movement of start-up staff across projects makes it essential for CROs to have the visibility to plan across their overall resourcing strategy. There is a vital need for technology used in study start-up process to facilitate more effective and proactive resource planning at the country level.

Downtime

Traditionally, sponsors and CROs have compartmentalized their start-up activities, inevitably leading to inefficient “handoffs” between the different steps in the process. The resulting gaps between activities can range from hours to days, increasing overall clinical trial timelines and potentially compromising study budgets. The use of technologies that enable real-time sharing of documents and information globally can overcome this downtime between processes.

The number of handoffs and errors, and the resulting downtime throughout the start-up process can be reduced by the use of IT technologies that utilize workflow management systems, alerts, document collection, version control, and reporting, and can produce greater efficiencies in CPM and workflow design.

Next time

In this article, I’ve highlighted some of areas in which the study start-up process is compromised by inefficiencies. In the next post, I’ll take a look at the emergence of new approaches to streamline these start-up procedures, and in particular what new technologies have to offer.

References:

1. Schimanski, M. Kieronski, “Streamline and improve study start-up,“ Applied Clinical Trials, Vol. 22, Number 9, September 2013.
2. Bio-IT World, “IntraLinks Survey Highlights Need for e-Clinical Document Exchange Tools,” (2011), http://www.bio-itworld.com/news/06/14/2011/IntraLinks-survey-need-clinical-document-exchange.html.