The biopharmaceutical industry strives to ensure patient wellness and safety by producing new drug candidates that have undergone rigorous testing and approval by global health authorities. However, industry inefficiencies around approaches and processes for drug development have caused roadblocks for successfully starting, recruiting, executing and completing a clinical research study, ultimately delaying development of needed medications for patients. Challenges such as:
- Decline in clinical investigator accessibility and interest: To add to the complexity, research shows a low and decreasing number of clinical investigators who are available to lead ongoing research (28,000) since 2001. In fact, a large percentage of available clinical investigators have only participated in one research study in their careers at 85%.1
- Clinical research awareness: The number of clinical research studies that are currently being executed (over 200,0002) compared to the percentage of people, who once aware of the clinical trial, would want to participate in clinical research (43%3).
- Delays in bringing drugs – to clinic – to patients: On average, it could take 10-13 years to bring a drug into the market. All stakeholders continue to be plagued by challenges that can delay or, even prevent the delivery of safe and effective medicines to the patients that need them most.
TransCelerate, through its collaboration of biopharmaceutical member companies and commitment to innovative solutions, aspires to create a future state for clinical research where these challenges are no longer roadblocks to success — a vision consisting of healthcare providers (HCPs) that are activated and supporting patients along their healthcare and clinical research journey, where HCPs, sites and investigative staff are fully supported by trial sponsors, researchers have access to the data they need to improve study design, and medications are developed faster for patients in need.4
Contributing to TransCelerate’s ability to achieve these goals are our Strategic Priorities:
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.Related Challenges for Patients:
- Role and impact of clinical research is not broadly known and misconceptions surrounding clinical research persist.
- Low engagement with clinical research and low consideration of clinical trials.
- Missing or broken links between available clinical trials and potential participants.
- Complex, difficult to navigate trial information landscape.
- Trial participants lack valuable education and easy-to-understand information about their participation in a clinical trial.
- No widely accepted framework to understand and measure the patient experience in trials.
- Lack of defined processes, methods, and tools to effectively implement patient technologies to improve the patient experience in trials.
- Redundant and repetitive training and study start-up tasks that delay trial start and reduces time that can be spent with patients
- Difficult for qualified sites to access study opportunities
- Poor communication between sites and sponsors
Enable the industry to move toward greater harmonization of process and facilitate the necessary and required sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.Related Challenges:
- Lack of consistency around tools and documentation, such as protocol design, within and across trial sponsors that cause disruption and delay for sites, investigators and study participants.
- Lack of data reuse and access to historical data that limits informed decision making and increases patient burden.
- Manual set-up of clinical systems is time consuming, inconsistent, costly and prone to error, delaying development medications for the patients that need them.
- Clinical research, healthcare and market data are captured across multiple sources in multiple structures preventing system interoperability that, when connected, will enable and drive insights, as well as allow for the integration of various data sources.
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.Related Challenges:
- Inconsistent clinical data transparency and reporting practices.
- Extensive and costly data capture, collection, transcription, reconciliation and monitoring investments.
- Real-time access to important study participant and research data is limited.
- Inconsistent global quality requirements and process are fragmented.
- Lack of international harmonization of the wide variety and sometimes ambiguous regulatory requirements.
- Management of the volume, variety and velocity of pharmacovigilance data.
- Lack of automation and technology to aid the patient safety space.
Want to learn more about TransCelerate? Check out our video to understand why we’ve joined together, what we’ve accomplished and what we have in store for the future.
2Number of Registered Studies, Interventional Studies https://clinicaltrials.gov/ct2/resources/trends