In this blog post, we discuss ways in which companies small and large can access the expertise of the world’s most respected medical experts to systematically enable timely risk detection, generate actionable insights into drug benefits and challenges, and enhance the safety/competitive profile of drugs as they move down the clinical trial pathway.
Partnering with outside experts can lead to better-defined data gathering, earlier risk signal detection, an advanced look at competitive advantages and, ultimately, a value-enhanced, streamlined approach to leveraging intelligence gathered from clinical trials.
Background: Putting it in Context
Medical expertise, an indispensable part of every stage of the clinical trial process, must come from both internal and external experts. Internal medical experts will always be an integral part of clinical study design, trial execution and drug approval, but the thoughtful incorporation of independent, leading medical experts, supported by the right analytic tools, can significantly enhance the ability of organizations to de-risk their clinical trials and create better quality regulatory submissions.
By tapping into external thought leaders, companies can better identify and mitigate risks and address critical needs. They will be able to:
- Boost their internal teams with the right kind of expertise (medical, clinical, safety).
- Rapidly assess the impact of safety signals in clinical trials and make proper modifications.
- Integrate independent opinions to reduce potential bias into benefit/risk decisions.
- Standardize evaluation of key clinical trial endpoint to optimize regulatory submissions.
- Demonstrate a systemic approach to enable safety compliance.
Based on our extensive work connecting clients with the world’s leading medical experts across the various stages of clinical development, we know these needs are universal. Only the degree tends to vary, based on company size and maturity.
When sponsors take a more systemic approach to address these multidimensional needs, they can optimize opportunities for de-risking clinical trials. For instance, dangers to patients can be mitigated early in development, which can prevent failed clinical trials or regulatory requirements for additional testing. When properly implemented, this approach produces time/cost/competitive advantages in clinical trials.
The Concept: A De-Risking Package
Empowering organizations with a complete de-risking solutions package enables them to:
- Understand and define risks early on (even when it is not obvious).
- Avail themselves of “just in time” delivery of appropriate expertise.
- Supply the experts with the right information and analytics needed.
- Deliver expert recommendations with appropriate regulatory rigor.
Market Readiness: Uncertainty and Unease
Leaders in the clinical trial space are not highly confident that they have access to the right medical information at the right time to mitigate risks and ensure patient safety in clinical trials, according to a recent FDANews/CenterWatch survey.
These decision makers state that they would be most likely to seek medical thought leadership to evaluate the risks vs. benefits of clinical trials. Specifically, the top three areas of external expertise they would see are:
- Therapeutic expertise for protocol design
- Medical oversight expertise for safety monitoring
- Analytical expertise for timely review/assessment of clinical trial data
As one respondent expressed, “Not any one company can have all the expertise; so, the goal is to bridge gaps.”
The respondents recognized tangible benefits to using external medical experts. At the top of the list:
- Timely intervention to change the course of clinical trials
- Timely risk mitigation
- Enhanced patient safety
Well over half of the survey respondents indicated that they would use independent medical expertise as often as possible—if it were easily available.
Finding the Right Partner: WCG Readiness
We have the people, processes and technology to ensure scientific review is done right. By leveraging our global network of experts, internal expertise and proprietary technology, we provide the strategic guidance sponsors need, including:
- People: A pre-screened network of over 600 of the world’s most respected medical experts with deep therapeutic and clinical trials expertise whose experience has elevated safety signal detection, competitive advantage spotting and timely risk mitigation to an art form
- Processes: Leading process expertise in core regulatory-mandated safety surveillance and pharmacovigilance
- Technology: A regulatory-grade analytic engine purpose-built to support independent medical experts
The seamless integration of these components enables the right experts to assess the right intelligence at the right time, thereby optimizing a company’s ability to de-risk its clinical trials.
You can’t afford to get any aspect of your trial wrong. We can help you get it right.
ACI is the market leader in the independent medical expertise space, having created a ‘virtual faculty’ of over 600 of the world’s leading medical experts who are experienced clinical trials and empowering them with the analytics they need to de-risk clinical trials. Clients have historically come to ACI to support them with expert committees. Our partner Vigilare has been providing companies with end to end pharmacovigilance and drug safety solutions. A client expressed what we do best:
“You show me what’s coming around the corner, before I have even spotted the corner.”
In short, we consistently and meticulously de-risk clinical trials. Our collective experience over the years with both planned and rescue efforts reveal, optimal benefits from expert medical expertise can be realized when this aspect is thoughtfully woven through the entire fabric of the clinical trial journey.
Having experts outside of a company’s ecosystem as active partners can lead to better defined data gathering, earlier risk signal detection, early insights into competitive advantages and ultimately, a value-enhanced, streamlined approach to leveraging intelligence gathered from clinical trials.
 survey in progress; early results based on 52 respondents
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