First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a treatment. These studies often have a small number of subjects with a quick turnaround, but more complex Phase 1a/1b studies are increasingly common. Sponsors are often concerned with both timelines and costs for early phase studies, given the risk of failure to proceed to subsequent phases.
Data Management activities have an important part to play in meeting the challenges in Early Phase Studies. The collection, integration and validation of high-quality data is an integral part of the clinical trial and can support the success of a trial.
CHALLENGES WITH EARLY PHASE STUDIES
Data Managers (DMs) bring skills to bear on each of the following challenges.
|Challenge||Early Phase Concern||Data Management Perspective|
|Protocol Design||Selection of dose is a primary issue for early phase studies||DMs work closely with Statisticians to capture and report the data needed to evaluate effective dosing. DM Therapeutic Experience to provide accurate validation of study design and data checks|
|Data Accuracy||Reliable and valid data are needed for decision making to answer the question: is the treatment safe and effective? Should the treatment progress to the next phase?||Prepare the Data Management Plan and Data cleaning Plan to ensure accurate data collection. Upfront identification and mitigation of risk using Risk Based Management|
|Timeline||Study timeline planning affects patients as well as various functions in obtaining, analyzing and presenting results; timeline has a definite cost impact||Experienced DMs who are skilled in handling early phase studies can:
1. Communicate & co-ordinate with right group
2. Meet/accelerate the time from study set up to database lock
|Technology||Improved technology for remote data monitoring, electronic data capture, and visualization of data is a real benefit for improved data||Multiple industry led EDC Tool experience helps to fast-track the study GO-Live and Database LOCK and ensure sufficient and accurate data collection for Statistical Analysis. Visualization tools can quickly impart important information to stakeholders.|
|Site Concerns and slow recruitment/retention||Slow recruitment can indicate problems with site and patient selection as well as disrupt projections on study timeline and costs||Experienced DMs collaborate with site and Clinical Operation Team to train, guide and provide effective ways to collect data as per the study requirement. This helps to:
1. Avoid Data Loss
2. Meet the stringent timeline
3. Identify site-based problems using Risk based management approaches
|Cost||Clinical trials are very expensive and Sponsors want to keep costs in line with their planning||A DM team that works intelligently, employing templates, tools and processes for a cost-effective delivery. Use of on-shore/off-shore resources.|
|Experienced Resources||Getting the right resources, experienced in the study design needs can impact timeline, costs and quality of results||DMs who are experienced in PK/PD evaluations and Early Phase study requirements can
1. prepare concise specifications quickly,
2. reconcile and provide clean data for endpoint analysis.
Our Data Management team has handled over 400+ Early Phase studies in different therapeutic areas.