Respiratory Drug Development Solutions
There remains substantial unmet medical need and challenges in the treatment of respiratory conditions. Covance understands these challenges, including those faced in respiratory clinical development and we have the breadth and depth of experience required to help you overcome them and achieve success.
Understanding unmet needs in respiratory diseases
- Proportion of patients with uncontrolled asthma remains high (45% – REALISE survey), despite treatment innovations
- Economic costs of asthma are among the highest for non-communicable diseases (~$55 billion per year in U.S.)
- Median survival is only three to five years from diagnosis, despite decades of clinical research
- Lung transplant is the most effective treatment, but only a small number of patients qualify
- Existing IPF treatments do not modify the long-term decline in lung function
- CF remains one of the most common life-shortening inherited diseases, despite breakthroughs in targeted therapies
- Management of pulmonary exacerbations is suboptimal
- Existing COPD treatments do not modify the long-term decline in lung function
- By 2030 it is predicted that COPD will be the third leading cause of death globally
The challenging and competitive respiratory drug development landscape causes several challenges throughout the development process. To ensure you can achieve success in your respiratory clinical trials, Covance has developed solutions for each of the following challenges.
Respiratory drug development pain points.
- Suboptimal patient recruitment due to competitive trial environment
- Difficulty finding high-performing investigators
- Poor patient retention over long trial periods
- Ineffective trial design leading to inappropriate enrollment and eligibility creep
- Data inconsistencies within and across sites
- Insufficient support with regulatory approval and commercial reimbursement
- Pediatric-specific challenges, including enrolling appropriate patients, conforming to pediatric regulations and maintaining patient compliance
Extensive experience in respiratory clinical trials.
Covance has deep experience in respiratory clinical development, with global expertise in asthma, COPD, upper and lower respiratory infections, cystic fibrosis, idiopathic pulmonary fibrosis, interstitial lung disease, acute respiratory distress syndrome and many more.
- Supported over 585 immune-mediated inflammatory disease (IMID) clinical trials in the past five years, including at least 92 asthma, 67 COPD, 20 CF and 20 IPF trials
- We have had at least 1 IPF trial active per year since 2004, and executed the pivotal studies leading to FDA approval of the first IPF-specific treatment
- Helped develop 14 of the 15 top IMID drugs, of which a number are indicated in respiratory conditions
- Covance has participated in 169 studies involving pediatric patients, equating to approximately 20% of all U.S. pediatric trials
Expertise in specialized respiratory tests and analysis.
- Pulmonary function testing, centralized spirometry and fractional exhaled nitric oxide (FeNO)
- High-resolution computed tomography (HRCT)
- Measures of exercise capacity, including six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET)
- Sputum sampling and processing for biomarker assays, microbiology and cytology
- Bronchoscopy with bronchoalveolar lavage (BAL)
- Patient-reported outcomes (ePROs/diaries) and questionnaires
Our extensive experience in respiratory clinical trials has afforded us the expertise, along with the necessary infrastructure, to help you gain accurate data, meet timelines and save costs in your respiratory clinical development program.
We know how to address the pain points of respiratory clinical trials.
Optimize study planning and speed patient enrollment with evidence-based approaches
Clinical knowledgebase housing more than 40% global clinical trial data at any one time
Target patient populations for efficient recruitment
- Partnership sites giving access to 150,000 asthma/COPD patients
- Targeting experienced sites with high recruitment rates using Xcellerate® Trial Design
- Specialist inflammatory biomarker analysis, e.g. eosinophil cationic protein and periostin
Leverage informatics capabilities to locate investigators
- Access to more than 3,100 asthma and more than 2,600 COPD investigators worldwide
- Identifying highest-ranking investigators using our historical investigator performance database
Improve patient retention through education and support
- Incorporating an active site management strategy
- Pre-existing patient relationships and established patient support systems
- Patient-centric trial designs incorporating voice of patient and/or parent insights
Control placebo response with study-specific staff training
- Pressure testing protocol decisions before finalizing entry criteria
- High-quality training of site staff and careful selection of patients
Yield accurate data using centralized analysis and highly trained staff
- Centralized objective endpoint analysis to reduce variability
- Ensuring availability of appropriate instrumentation, and providing study-specific training on instrumentation use, and data collection, handling and interpretation
Optimize product pricing for successful market entry
- Dedicated team of global regulatory experts with up to 30 years’ experience each in engagement with both global and local agencies
- Generating real-world evidence to demonstrate molecule efficacy and communicating product value to key stakeholders via Covance Market Access
Use specialist pediatric investigators and sites when necessary
- Expertise in pediatric protocol design and implementation
- Identifying and supporting high-performing pediatric investigators
- Formulating a pediatric development plan and engaging regulatory agency early in development process
- Understanding patient challenges using voice of patient and/or parent insights, and incorporating into trial design
- Site infrastructure to support patient and family needs