Priya Jayaraman, Ph D
Chair of Clinical Trial Chapter (ARPA)
Synergy between regulatory associates and clinical operations team
Regulations play a key role right from the time when a product is conceived and even after it is placed in the market. Throughout the product lifecycle, it is essential for a regulatory professional to interact with various teams. Clinical operations team is one of the key ones amongst them. It is essential for this team to discuss with regulatory associates on local regulations and the data to be collected during clinical development phase. Clinical safety and efficacy data form the crux for approval of any biopharmaceutical or medical device product.
A sound clinical trial and risk management plan is essential for efficient data collection for submission to the regulatory authorities. Regulatory associates who provide crucial inputs in designing the trial need to understand the clinical relevance of a product and possible problems during execution of trial. This ensures relevant data is collected and delays are avoided. Their role starts right from the stage of preparing trial documents such as informed consent form (ICF), protocol and safety management plan so as to adhere to local country regulations. For example, a trial to be conducted in India requires video recording of patient and doctor during consenting. The clinical trial team needs to ensure that this video consenting is recorded in the format required by the local government authority. Should any legal issues arise from the patient side on lack of information about research, these consenting videos are used during proceedings in court. Lack of collection of these data can create serious legal issues for the company testing the product. Differences arise in medical procedures too; some countries may not follow same medical protocols due to inherent differences in working procedures. For example, paediatric growth chart followed for western children is different from a growth chart followed in Asian children. This can lead to difference in scales used in the protocols which need to be accounted for during data analysis post trial. Regulatory and medical team which is well versed can help the clinical operations team by incorporating necessary changes while preparing the trial management plan.
Another aspect regulatory team needs to educate clinical team on is the record of safety events. Safety data is one of the vital documents which regulators use to assess the product. The reporting timelines, assessment of a safety event and compensation for severe adverse events vary from one country to another. For instance, in most countries if any trial related injury debilitates the patient for life long or causes death, the patient is entitled to all the medical expenditures but in India, the patient is also eligible for a monetary compensation over and above the medical expenses. There is a predetermined formula set by the authorities which is used to calculate the compensation to be paid to the patient.1 To ensure that such details are known to the clinical operations team, it becomes essential for regulatory associates to work along with medical team and convey these local guidelines. These need to accounted for in budgeting for expenses. The safety guidelines also determine the content of submission dossier for approval of a drug or device.
To reinforce the point, a regulatory professional is required to understand every step of product commercialisation and chart the shortest and most efficient pathway of product to the market. His or her role does not just involve administrative task of submission of relevant documents to the authorities but also requires them to communicate with relevant teams efficiently to address the needs. To achieve this, the synergy between regulatory and clinical trial team is one of the most crucial ones.
- Compensation to clinical trial participants in India: A gap analysis
Mohd Urooj et al., PMID 28929045
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