ProRelix Research provides tailored end-to-end management of clinical trials keeping cost and patient safety at the forefront. We help you navigate the complex path of clinical trials by offering study support from patient recruitment to statistical interpretation to help you achieve your goals for the approval of new or repurposed drugs.
New drugs are those that have not been previously evaluated for safety and effectiveness for the given indication and include prescription as well as over-the-counter drugs. The approval process for new drugs is lengthy, costly, and is associated with high attrition rates. New drug development follows the 505(b)(1) regulatory pathway for New Drug Application (NDA) in which all investigations, nonclinical and clinical are conducted by or on behalf of the sponsor. Major steps in the clinical trial phase for new drugs are as follows:
- Review of relevant information from the FDA or other regulatory agencies for the drug being investigated
- Submission of Investigational New Drug (IND) application to the FDA. An IND application is a request from the sponsor to the FDA to authorize the use of the investigational drug in human clinical studies.
- Phase I clinical study: assessment of toxicity and safety in 20-80 healthy subjects/patients
- Phase II clinical study: assessment of efficacy and less common side effects in 100-300 patients
- Phase III: final comparison of safety and efficacy with existing treatments/comparators in 1000-3000 patients
- NDA submission for marketing approval of new drug
- FDA review and response
In addition to new drugs, the FDA can also approve repurposed or repositioned drugs. Drug repurposing is a means of identifying new uses for approved or investigational drugs that are outside the scope of the original medical indication. Since preclinical tests, formulation development, and safety assessment are already carried out, drug repurposing is associated with reduced risk of failure, decreased timelines for the drug development process, and lower investment costs and thus present an attractive investment opportunity for pharmaceutical companies. Drug repurposing has gained traction recently in the COVID-19 pandemic era wherein therapies were urgently needed to combat this health crisis. In 2019, the United States Food and Drug Administration (US FDA) approved the use of remdesivir, a repurposed drug for the treatment of the coronavirus disease. The approval process for repurposed drugs follows the 505(b)(2) regulatory pathway which precludes the need for conduct of extensive safety assessments and preclinical tests. This avoids unnecessary duplication of studies as sponsors can rely on data already produced for the reference drug.
Whether your drug is a new or repurposed, ProRelix research will guide and provide support with clinical studies required to create a submission package for the NDA process which encompass
- Compilation of existing data from product labeling, literature or FDA’s findings of safety and effectiveness of a drug and its relevance based on current regulatory requirements to support applications for repurposed drugs
- Gap analysis for determination of additional clinical studies or bridging studies that may be required to support a new indication which may include Phase II/III studies for repurposed drugs and Phase I-III trials for new drugs
- Clinical trial support activities including:
- Protocol development, site selection and qualification, patient recruitment, ethics committee approval, informed consent, case report forms
- Study design (randomization, blinding), sample size, hypothesis testing, determination of clinical or pharmacokinetic endpoints
- Training programs for site personnel on protocols, GCP, and relevant guidelines
- Site initiation, interim monitoring, and close-out visits
- Communication with ethics committees and site monitors
- Handling protocol deviations and safety monitoring of participants
- Data management, maintenance, and archival processes
- Statistical analysis of data and interpretation of results, preparation of statistical analysis reports (SAR)
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