Safety Endpoints
Ophthalmology safety endpoints are critical in clinical trials, as even minor adverse effects can have profound and potentially irreversible consequences on visual function. These endpoints encompass a range of assessments from visual acuity to retinal integrity and are key to evaluating the safety profile of investigational treatments.
Various medications, from corticosteroids and anticholinergics to chemotherapies and antihistamines, can cause ocular side effects. These effects can range from mild dryness or irritation to severe vision-threatening conditions such as glaucoma, cataracts, or retinopathy. It’s important to monitor eye health during clinical trials of treatments with suspected ocular side effects.
MERIT has provided ophthalmology safety endpoints for the following indications:
- Alzheimer’s
- Bipolar/Schizophrenia
- Diabetes
- Epilepsy
- Major Depressive Disorder
- Malaria
- Myelin Oligodendrocyte Glycoprotein (MOG) Antibody Disease
- Multiple myeloma
- Solid Tumors
Cardiac
Given the prevalence of cardiac-related adverse events across various therapeutic areas, routine monitoring of parameters such as ECG changes (e.g., QT interval prolongation), heart rate variability, blood pressure fluctuations, and biomarkers of myocardial injury is essential. Stringent safety assessments help ensure that investigational therapies do not pose undue cardiovascular risks.
MERIT provides standardized collection and review of cardiac safety data assessments in all therapeutic areas.
We have specific expertise in the following indications:
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Exercise-Induced Bronchoconstriction (EIB)
- Idiopathic Pulmonary Fibrosis (IPF)
- Cystic Fibrosis
- Macular Edema
- Age-Related Macular Degeneration
Respiratory
Respiratory safety endpoints are essential in clinical trials, particularly for inhaled therapies, as the route of administration directly exposes the airways and lungs to potential adverse effects. Comprehensive safety evaluations of inhaled therapies must include assessments of lung function (e.g., spirometry measures such as FEV₁ and FVC) to detect structural changes. Inhaled drugs also pose risks of bronchospasm, inflammation, and long-term pulmonary remodeling, necessitating rigorous monitoring to ensure both the efficacy and safety of these therapies.
MERIT can provide standardized spirometry data collection and review for respiratory safety endpoints in indications such as:
- Inhaled Insulin for Diabetes
- Inhaled Corticosteroids for Autoimmune Conditions
- Inhaled Treprostinil for Heart Failure and Pulmonary Arterial Hypertension (PAH)
- Inhaled Beta-Agonists for Hyperkalemia