Monday, July 11, 2016

How Collaboration Between Stakeholders Will Transform Clinical Research


By April Schultz, Content Marketing Writer, Forte Research Systems

In the clinical research industry, communication between stakeholders is notoriously strained. Industry players such as sites, sponsors, CROs and patients often struggle to maintain adequate and effective communication, leading to strained relationships and ineffective clinical trial processes. Clinical research professionals have become increasingly aware of these roadblocks and are working to change the way the industry communicates. Transparency is now a buzzword heard at every industry event, including Vice President, Joe Biden’s recent Cancer Moonshot Summit.

While the need for greater transparency is apparent, some are unconvinced that the industry can change fast enough to achieve necessary levels of communication. To achieve transparency and gain greater efficiencies in clinical research, all stakeholders need to be on board and collaboration needs to be a key focus for the entire industry. Below are some key talking points that address this need for industry-wide cooperation.

Standardized data is a step in the right direction.

To achieve goals such as Cancer Moonshot, it’s imperative that the industry move towards a more standardized approach to data collection. Standardized data increases consistency and boosts the ability for multiple organizations to collaborate. Benefits also include a reduction of duplicate efforts, more accessible data and the ability to compare data sets and processes between multiple organizations.

As clinical trials continue to become more specific to individual areas of study, it’s essential that data is being used effectively and to its fullest potential. Data standardization is a first step to true industry-wide collaboration.

Patients want to know the results of their trials.

The rationale for sharing clinical trial results with participants continues to gain strength, possibly due to the growing movement for patient centricity in clinical trials. Extended follow-up with participants to communicate clinical trial results is becoming more of a standard, and for good reason. This follow-up both ensures participants are receiving the correct information and potentially increases their clinical trial satisfaction. Over 90% of clinical trial participants would like to receive the results of their clinical trial and many consider receipt of results a driving factor for future participation.

It’s becoming more evident that disclosing clinical trial results on ClinicalTrials.gov is inaccessible and incomprehensible for most patient populations. Due to this, communication among stakeholders (including patients) regarding standards and processes for return of results to trial participants is increasingly necessary.

Sponsors aren’t aware of many site struggles.

It’s no secret that there’s often a large disconnect between sponsors and sites throughout the clinical trial process. This disconnect leads to miscommunication, inaccuracies and strained relationships between both parties. It’s often particularly evident when CROs are involved in clinical trials. As the chain of communication grows, less and less information is relayed from the site-level to the sponsor.

While some sites think otherwise, many sponsors really want to know about problems at the site-level, particularly those involving the CRO. Monitor change fees are becoming more common, and collaboration with sponsors is the only way to increase the normalcy of this practice. To achieve greater communication between all parties, grudges need to be dispelled and collaboration needs to be emphasized to improve trial processes.

Moving towards a more collaborative clinical research industry is essential to improve processes and gain greater efficiencies in clinical trials. All stakeholders must be involved and strong effort must be directed towards transparency and open communication. As stated by a conference attendee, “transparency [in clinical research] is going to make everyone’s jobs better.”

Join over 1,100 clinical trials stakeholders from pharma, biotech, CROs and sites at Partnerships in Clinical Trials US in Boston on October 5 - 7 2016. Find out more here.


April Schultz is the Content Marketing Writer at Forte Research Systems, a developer of clinical research software. In this role, she is responsible for the creation and direction of Forte’s educational materials such as blog articles, eBooks and webinars. She manages Forte’s content calendar, oversees content posted to the Forte Clinical Research Blog and works with presenters to host Forte’s monthly educational webinar series.






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