What skills are important in PV other than PV?

What skills are essential in PV other than PV?

1. What is PV?

Pharmacovigilance is the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other medicine/vaccine-related problem.

2. Scientific skills vs supporting skills

1. Regulatory guidance: Scientific skills like GVP modules, CIOMS, and ICH -GCP guidance documents should be clearly known at a high level, to say the least. However, these are very detailed, so memorizing them is not an expectation; knowing how to interpret them in daily PV activities is.  

2. ICSR: ICSR is not limiting the knowledge to only 4 minimum criteria and how to do case processing. ICSRs also need to understand the criticality of each ICSR in the product safety file. For Seriously unlisted cases, especially any ICSR that can potentially be a signal, a critical assessment of labeling, seriousness, and causality is the first step. But going beyond this is essential as well. Product quality complaints, off-label use, and increased complaints related to product packaging issues also impact patient safety. For e.g., a lot of ICSRs with patients unable to open packaging issues for an asthmatic drug is a potentially severe issue, as this may cause asthma patients to not get the correct dose at the right time during an asthma attack. 

3. Aggregate reports: The starting point is PSUR, PBRER, and DSUR basics from regulatory guidance documents for the template and expectations understanding. However, for a PV professional to author, review, or contribute to PSUR requires many analytical skills. We need to know what the baseline safety profile of the product is, how to correlate sales volume data against the number of adverse drug reactions reported, have a clear strategy regarding which risk will need cumulative vs interval analysis, what articles to include, and how and which topics can be closed are some key answers to find for each aggregate report to then conclude if there is any change in the benefit-risk profile of the drug.

4. Signal detection: As much as every new PV professional wants to jump into signal management, knowing the signal management process through regulatory guidance is just the beginning. Identifying, validating, and proposing a signal outcome requires a thorough understanding of medical, scientific, and drug safety profiles. 

5. Risk management plan (RMP) and risk management measures:

 RMP is a big topic in PV, where all the pieces of PV come together for patient safety.  Identification of risk, proposing appropriate risk minimization measures, and evaluating those measures that are sufficient and effective for patient safety is a collective effort of everyone working in PV and also other departments. Every MAH has to ensure a favorable benefit-risk profile for each drug. To ensure this, it is essential to know how to scientifically put the risks associated with the drug with appropriate risk minimization measures to get MA approval or to continue the MA approval. 

6. Other: Some country-specific or local requirements are also necessary, primarily if you work on a product marketed in these territories. Health Hazard Evaluation Report, PLLR, REMS, PSMF. As PV works very closely with regulations, it is essential to know the regulatory requirements like MA application, CTD modules, MA dossier qualification, and post-submission expectations from the regulatory authorities. You are submitting NDA, ANDA, or for a new indication of a previously approved drug.

3. Supporting skills that are a must 

Having only scientific skills is necessary, but complementary skills that will help you implement your assigned tasks effectively and productively are also essential. 

In the world of PV, activities can most often not be planned as they depend on external factors—how many AEs are reported and when, what and when regulatory agencies send questionnaires, etc.

Hence, time management and prioritization are a must. PV also needs to collaborate with every department in a company (RA, Clinical) and an outside company (RA). Stakeholder management, influencing, negotiation, and good communication skills help a lot when implementing any PV process and ensuring its effectiveness. 

Other skills valuable in any other career, such as Presentation, leadership, and knowledge of Excel and Word, are also essential in PV.

4. Supporting skills based on role and KPI : 

Some skills are more critical than others for some roles within PV.

ICSR: Excel, safety database, time management, coding.

Aggregate: Stakeholder management, Excel, analytical skills, literature review

Signal: Looking at multiple datasets for meaningful patterns and trends. Signal database, RA database combing and downloading, statistics and epidemiology

RMP and REMS: Knowing HCP patterns and behaviors to understand which RMM and aRMM will be effective, visualizing, project management, influencing, negotiation, and assertiveness.

5. Where to find tools to develop? 

Coursera, UDEMY, and YouTube are probably PV academy training institutes for online and offline tools. 

6. How to ensure continuous development of supportive skills

The most significant source of learning is doing by learning. If you are in ICSR and want to develop aggregate skills, ask to contribute a few sections and listings in PBRER. Ensure that you stay up to date with regulatory guidance, but before that, ensure you are thorough with internal company SOP on the area of development you are focusing on. 

Written by:

Dr.Shraddha Bhange.

Connect with me Via the comments below. (I do not respond to Facebook messages)

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Reference:

Pharmacovigilance training materials | European Medicines Agency (EMA) (Europa. eu) 

Training resources (who. int)

Everything You Need To Know About A Career In Pharmacovigilance - Mentoring

Agreement to avoid ugly disagreements SDEA

 What is SDEA 

A service data exchange agreement (SDEA) is an agreement between two companies that ensures the roles and responsibilities of each company are clearly defined, especially related to the pharmacovigilance process. 

This agreement is necessary due to business requirements, such as pharmaceutical companies having to have partners in some countries instead of selling themselves or buying or selling their molecules to others. Often, an MAH may only be involved in distribution, marketing, or manufacturing. Knowing and defining who will do what in the PV process becomes essential in all such scenarios. This is also a requirement from regulatory agencies during audits or inspections.

 2. Types of SDEA 

As defined in the above image, there are various types of agreements. The most important and necessary one is between two MAHs. The SDEA can also have other supporting documents that may be used to define granular details, timelines, how to exchange information, etc. 

 3. When, who, and how do we write 

SDEA is written or drafted very early once the business agreements are signed. Usually, the pharmaceutical company with the global license or MAH initiates the SDEA. 

The SDEA should be finalized and signed before the first batch is in the market (worst case), but earlier is better. The safety database, SOP, Work instructions, and team readiness—in a nutshell, the PV system should be live and ready to onboard or delegate the product.

 4. Elements of SDEA

SDEA elements, as seen in the above image, are minimal basic requirements that must be defined. This is not an exhaustive list, and further granularity is required depending on the product, its risk minimization measures, local RA regulations, etc. Other factors that need to be addressed are BCP (Business Continuity Plan), Termination, confidentiality, etc.

 5. Challenges and Solutions

Challenges:

1. Data privacy can be challenging, especially if local laws vary.

2. Confidentiality policies may have differences that may be contradictory to SDEA terms

3. Meeting regulatory compliance requirements as per local laws and each company's policies

Solutions:

1. Regulatory adherence: Helps companies meet legal obligations at local laws. 

2. Efficient collaboration: Once roles and responsibilities are clearly defined, it helps meet local and global regulatory requirements.

3. Data quality:  Maintains safety data's accuracy, completeness, and timeliness.

4. Clarity: Confidentiality and data privacy should be clearly defined to avoid any inspection and audit findings.

Having SDEA is of utmost importance so that both companies and parties work and collaborate together. This will ensure that there are no ugly disagreements later.

Written by:

Dr.Shraddha Bhange.

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References:

Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems (Europa. eu) 

Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question | Therapeutic Innovation & Regulatory Science (springer.com) 

https://pvdrugsafety.com/2021/11/pharmacovigilance-agreements-pvas-and-safety-data-exchange-agreements-sdea/ 

Literature review in pharmacovigilance

1. Why is a literature review required:

A literature review for continuously monitoring the product's safety profile is a regulatory authority requirement across all countries. However, it goes beyond meeting compliance requirements as it helps MAH/Pharma companies utilize real-world data in various other documents, e.g., new indication applications, better understanding of the risks, and introducing or adjusting risk minimization measures as the safety profile changes. Literature serves as a source of information outside the company database. 

 2. Which databases are used for literature: 

The European Union has published a list of active substances (drugs) that need to be monitored in the literature. Other regulatory agencies may or may not have such an explicit list or name of drugs published; however, when a product has active PSUR, RMP, or any risk minimization measures, it becomes pertinent to have a literature review for those products. A literature review for identifying cases/ICSR is required for all products; hence, having one database for literature is mandatory. However, the industry standard is to have at least 2 databases, and whenever required, especially for MAH in European countries, local literature in the local language also becomes mandatory.

3. Literature search strategy:  Literature search strategy depends on three critical factors.

1. Phase of development of product and the status of the product

    A product that is an originator and still in a clinical development phase may require a class search or a search focused on toxicology, animal studies, etc., as the real-world data may be limited. However, for a generic product with a well-developed safety profile, the search will be limited to molecules and collecting natural clinical settings usage and patient outcomes.

The most common and required terms are adverse event, class and product terms, pregnancy and breastfeeding, and pregnancy outcomes.

2. Literature database 

This also drives the way we use search terms and the technical aspects, such as using the correct characters.

3. Local vs. Global Literature

The search strategy will also change based on local or global search. In the case of specific terms used locally in clinical publications, those will need to be targeted. 

4. Broad vs narrow search strategy

 The search strategy can be broad or narrow depending upon where the articles will be used and for what. When the risk is not established or not characterized, we usually use signal validation in the broad search. However, we use narrow when the risk is well known, and we want only certain aspects to be characterized, e.g., prevalence in specific populations. 

 4. Where are literature articles utilized 

The literature in PV is not limited to ICSR or signal management. It can be utilized for aggregate reports, e.g., PSUR, DSUR, etc. Additionally, for new indication applications, designing a study to determine which study safety outcomes and Benefit risk assessment.

 5. Points to consider for literature articles 

 5.1 ICSR

Validating an article as an ICSR from literature is the same as in any case: 4 minimum criteria. However, the same 4 minimum criteria must be relevant to the literature source. 

Product: Is your product available in this market/country? 

Is the literature article date or use of the product mentioned in the article after the product was launched in that country/market? 

Does the article mention the brand name or have the same composition as your product? 

We need to address these questions before adding this to the safety database.

Event: Add only events that occurred with company products or events after the company product was started. Add events that the author attributed to the company product.

Reporter and Patient: This criterion has no change per se except that patient identifiers must be available in the article. A table of patients with their age/gender, categorized into products they have taken or events that occurred. In a nutshell, we need to know that there were separate patients.

 5.2 Aggregate safety reporting

Articles that need to be included in the PBRER depend on multiple factors, e.g., sections in the PBRER, i.e., sections 9 or section 15, or 16. It also depends on the baseline safety profile of the product, what we know about the individual risk, and what outcome is expected from that section or risk. If it's a second PSUR, is there any particular request from PRAC? Generally, articles with large populations, varied/diverse patient populations that were not studied, specific outcomes, and changes in severity, seriousness, and frequency will be included. Articles that provide more information on the mechanistic action of drugs (previously unknown) or articles that provide new or relevant disease pathophysiology will also be included.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

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References:

1. Detailed   guide regarding the monitoring of medical literature and the entry of relevant information into the EV database by the EMA (Europa. eu)

2. Welcome - Embase

3.MEDLINE   (nih.gov)

4. Allied    and Complementary Medicine Database (AMED) | EBSCO

Pharmacovigilance readiness for a Successful Product Launch

 Pharmacovigilance Readiness for a Successful Product Launch

Product launch is the most critical milestone for any pharmaceutical company and, consequently, even for vendors that support the company. As pharmacovigilance professionals, we may not know the extensive details from marketing and sales perspectives on how the launch is planned, but we do need to know more from regulatory and clinical perspectives and, of course, in detail about pharmacovigilance involvement in product launches.

As described in the figure below, there are different phases for the product launch, and these phases may usually take 1-2 years. Hence, the launch itself is usually planned 3-4 years ahead of the date the Pharma is planning to be in the market. 

Pharmacovigilance readiness starts as soon as the company decides to conduct a study for the product and to be its MAH. However, the clinical trials and post-marketing phases need to be aligned appropriately, as both requirements differ.

Which departments are involved in the launch 

The leading department or function is the marketing/brand function, which is usually comprised of leaders from all functions, i.e., medical affairs, clinical, regulatory, manufacturing, leadership, legal, finance, quality, and pharmacovigilance. 

Role of PV team 

 Launch readiness 

The PV team is a support team for this activity. Once the information is received from the launch team (the marketing team is the lead) the critical factors to consider are

1.  PV systems as per health authority requirements:

Standard operating procedures (SOP) for ICSR, AGGREGATE, SIGNAL. LITERATURE, SAFETY SYSTEMS ETC

Pharmacovigilance System Master File (PSMF) is ready

Product configurations in the Safety Database

Regulatory requirements are aligned in SOP, Database, and overall complaint

   

5. Literature set up:

The literature database is identified e.g. MEDLINE and Embase and if needed, another database

Global literature and Local literature in local language

Literature search strategy for product for ICSR and Aggregate. Literature search strategy for the PBRER section on risks.

6. Local country-specific requirements:

Suppose the product was approved without any studies or requirements fulfilled in local regions. In that case, local country-specific requirements from health authorities should be fulfilled at the time of local launch.

7.  RMP and risk minimization measures:

A risk minimization plan and measures (routine and additional) should be specified. Additional risk minimization measures like patient leaflets and healthcare professional cards have to be approved by the pharmacovigilance team at the time of launch and no later than that. This allows them to implement. If needed, the PV team needs to train the marketing and other functions involved in implementing education materials and additional measures.

8. Aggregate reports:

The schedule for aggregate reports (PBRER, DSUR, and PADER) should be finalized. The templates can be populated, and the strategy for presenting each section in this document, especially the safety strategy regarding risks, should be ready.

9. Signal management system - manual vs. database, which sources will be used (safety database, literature, EVDAS, FAERS), etc.- should be formalized and documented as part of the signal SOP or Signal plan at the product level if a function level does not exist or is different.

This is not an exhaustive list but a summary of critical requirements. Other requirements to be taken care of are training the PV team and other functions as required and creating an implementation plan with a dedicated project manager. 

 

 Written by:

Dr.Shraddha Bhange.

Connect with me Via the comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home

References :

1. Pharmacovigilance: Overview | European Medicines Agency (EMA) (europa.eu)

2.Smart Safety Surveillance (3S): Proven Approach to Building Functional LMIC Pharmacovigilance Systems (diaglobal.org) 

3. 2177-Successful-Biopharma-Product-Launch-v2.pdf (lek.com) 

Compliance in PV- MAH and Vendors

Compliance in Pharmacovigilance by 

Marketing Authorization holders and vendors

MAH needs to oversee its pharmacovigilance even if it has outsourced it to vendors. We all know this, but the implementation is critical.

The oversight starts with choosing the right vendors and ensuring checks and balances are in place. Vendors also need to have a robust and efficient partnership with their clients, going beyond just providing services to being partners. How do both achieve this synergistically?

Process level requirements:

1. An SOP should be in place at the QA level that describes the vendor selection process, selection criteria, and onboarding.
2. This SOP is at the company level and needs to be modified by the pharmacovigilance department/function. 
3. Mandatory audits along with the noted deficiencies and their corrective and preventive actions with timelines were conducted.
4. Quality monitoring metrics need to be in place for each activity that is outsourced e.g. ICSR quality metrics, PSUR quality checklist
5. The statement of work should be as clear as possible
6. Safety management plan- detailing for each activity (e.g., diagrams) how the ICSR workflow looks between MAH and vendor from receipt to submission. The same level of granularity is for aggregate reports from a kick to submission, signal detection, literature, HA requests, etc
7. Vendors must prepare client-specific documents, such as safety management plans, training presentations, QC checklists, and work instructions. 
8. Frequency of meetings and collaborations with various levels of team involvement, e.g., governance meetings with senior leadership, which can be quarterly, weekly meetings with the operational team, etc.
9. Monitoring plan that includes Key performance indicators that will be monitored, process, SOP, etc
10. Training requirements need to be fully discussed, and a training plan that will help frequent upgrades and awareness of vendor team on MAH's changing process needs to be in place
11. Team details (org chart, CV, JD) need to be made available at least for critical roles

Metrics and beyond for effective PV systems and functions

A vendor—MAH needs to be open, transparent, and honest with each other. Leadership plays a vital role here. Having frequent connections and dialogues helps immensely.

An MAH needs to understand and respect Vendors' opinions and suggestions. A vendor also needs to take a tailor-made approach when needed to meet MAH, where they have scientific justification for doing things according to their products.

Frequent training and workshops surely help build expertise on the vendor side that is imparted by MAH.

 

 Written by:

Dr.Shraddha Bhange.

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Pharmacovigilance(PV) is not a cost center its a cost saving centre

                                Pharmacovigilance(PV) is not a cost center its a cost saving center

If you have worked in mid to senior roles in PV, you may have across this dilemma where we need to continuously convince, communicate and influence other non pharmacovigilance departments regarding the importance of pharmacovigilance. And the more difficult task for someone in leadership is to also break the myth that "PV is a cost center" meaning PV does not bring any money and on contrary we have to invest the money in running the pharmacovigilance department. 

And the basis of this argument, is actually coming from the fact that, pharmacovigilance requires setting up the call center (toll free number, telephony and employees working 24/7 to handle the calls), then collection of adverse event via other sources, safety database (very costly licenses), and other application supporting safety database, costly aggregate reporting applications, signal detection applications, so on and so forth. All this applications need to be validated and upgraded every time, hence this is never ending payments to the application owners. Also its a niche area so the human resource have to be highly trained and experts (pharmacists, doctors) so this also adds to cost. Moreover the inspection and audits add to the cost. So what people perceive does have the basis?  Owing to all of this factors, there is always an ongoing struggle to get more budget and investment for pharmacovigilance related assignments in PV department.

How do we change this perception? No definite or one size fits all answer. But one thing we can do is to convert our data that we analyze and the outcomes we generate from this data into meaningful and relevant easy to understand impact and value we create for patients.

This are thinking points for each person working in pharmacovigilance and not for the department heads, because as a working professional even when we work as data entry, we need to know the value and impact and importance of our own PV work we do. Additionally we need to prepared to also spread the awareness and message to others whenever needed.

Key components that can be used for building our case

1. Regulatory expectations: 

Understanding and complying to the regulatory guidance is not an easy task. While the regulatory affairs department is the one leading the dialogue and ensuring the compliance, pharmacovigilance is the one who is implementing and ensuring we have documented evidence to showcase our compliance to regulatory authorities. 

Markets the drug is being marketed are covered by that country's pharmacovigilance regulation from national health authorities. Although at high level the PV requirements remains consistent they are changing, evolving and differing at country level This needs to be showcase on how we meet those specific country requirements.

Having a core data available that can be presented regarding the most complex health authorities requirements and how PV meet them with ongoing addition of examples on changes adapted to meet this HA compliance will make it easy for non-PV leadership to also understand importance. E.G. Instead of showcasing we met FDA requirements, add and example that FDA requirements and give example on them how they were met and what was the outcome.

 2. All is well until its not /Inspections

Build and maintain a database on pharmacovigilance inspections done by various regulatory inspections in terms of name of health authority, type of inspection, duration, inspectors, findings and category of each finding, outcome of inspection, what were corrective and preventive actions implemented. Talk about the outcome especially positive how it saved money in terms of not having non compliance.

3. Outsourcing vs inhouse 

The age old dilemma of having a pharmacovigilance department in pharma company or to outsource the PV to CRO/KPO/BPO (Vendors). Both has its own merits. Clear, Definite and Ongoing continuous evolving PHARMA-Vendor model of partnership serves as the best solution. For a pharma company a due diligence on Vendor is must i.e. are the process set, is it working model, what would be cost of implementation, how much oversight will be needed. Ultimately having an actionable plan that can be referenced in terms of the business value the vendor is bringing is must.

4. Data points that can be used

While showcasing the impact and value pharmacovigilance creates, the easiest data points is volumes i.e. how adverse events are received and processes (ICSR volumes), submission compliance ( timelines met to submit to each health authority) how many aggregate reports processed ( PSUR, DSUR, PADERs), how many articles reviews, how many data sources screened for signals, number of signal identified and validated.

The tricky data points that are difficult to put in coherent and relatable manner are what this means for business and patients. For this we need to build stories, if a signal is validated how was it addressed and how it helps patients, if there was a health authority request how was it managed. If there was non required ask by health authority and we could say no and it was accepted e.g. conducting a phase IV study, how much money was saved etc.

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Dr. Shraddha Bhange.

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Clinical Safety

A. Definitions of Clinical Trials:

Clinical trials (CT) are research studies performed to discover new treatments that are safer and more effective for the prevention, detection, or treatment of diseases. In this blog, I have interchangeably used clinical trials and clinical studies.

1. Phase I Trials: For the first time, a small group of people, healthy volunteers (20–80) is tested with an experimental drug or treatment to assess its safety and identify any side effects.

2. Phase II Trials: The experimental drug or treatment is given to a larger group of individuals (100–300) to verify its effectiveness and further assess its safety.

3. Phase III Trials: Large groups of participants, the general population (1,000–3,000) receive the experimental drug or treatment to confirm its efficacy, monitor side effects, compare it to standard treatments, and gather information for the safe use of the experimental drug or treatment.

4. Phase IV Trials: Post-FDA/HA approval and public availability of a drug, researchers continue to monitor its safety, collecting additional information on the drug or treatment's risks, benefits, and best use.

Various other types of definitions are expected to be known and concept understood e.g. interventional studies, observational studies, PASS (Post-authorization safety study), Randomized trials etc.

B. PV-related elements for Clinical 

 1. Design of study: 

The safety team is involved from the beginning of the study i.e. study concept or proof of concept along with other departments such as clinical, medical affairs, marketing, and regulatory. 

Which population needs exclusion based on the data available in terms of risks or data unavailable where we cannot specify or characterize the non-reversible or non-treatable risks i.e. teratogenicity, mutagenicity, etc. Which population will be included based on maximum data generation to understand the benefit-risk profile of drug with minimal patient safety concerns and a cost-effective model. The safety team is also involved in the study milestones i.e. interim report, final study report, etc.

2. Clinical study protocol safety review: Clinical study protocols are the document that will describe the title, aim, methods, monitoring of patients, guidance for investigators for conduct of trials, and primary and secondary outcomes for the study. This document needs to be reviewed by the pharmacovigilance/safety team. The sections in the protocol about the study concept in itself e.g. is this the correct population for the study outcomes, are there any restrictions due to safety reasons, which SAE will be expected. Instructions for the investigators on identification, treatment, and prevention of known SAE associated during the study conduct will be reviewed by the safety team.

 3. Informed consent form (ICF): This is a document that is signed by the clinical trial participants and describes the risks associated with being in the CT. This document is prepared by the clinical team; however, it is reviewed by the pharmacovigilance/safety team. This document is designed in a very simple form so that layperson/common man/nonscientific person should understand. Each adverse event added in the ICF should be simplified and the usage of signs and symptoms is preferred to diagnosis as patients/participants will be able to identify them easily. The safety team has to ensure the adverse events are addressed appropriately as per the current safety profile of the drug. 

4. Clinical study report submission: The interim study report and final study report are major milestones where the safety team will also review the study report in terms of the presentation of adverse events and the conclusion on the safety of the product. 

5. MA application based on study and safety involvement: 

The marketing authorization dossier requirements are complex and varied across regulatory agencies. One critical and consistent requirement is the presentation of data and its analysis with a conclusion on the positive benefit and safety of the product. The clinical data from the study has to be reviewed by safety and its analysis based on the seriousness, severity, reversibility, and treatability of the adverse events described and then categorized and characterized into risks.

6. Scientific elements 

While preparing, conducting, and concluding clinical trials there are key scientific principles that are expected from a safety team to be aware of.

1. Pregnancy prevention:

Classification of the investigational drug if it fits the profile of teratogen or genotoxic if yes, then how will the study team ensure pregnancy is prevented. The contraception methods and duration of contraception must be described. if pregnancy occurs how it will be addressed. Usually, this means termination from the study if they choose to continue it. If the product is not teratogen or genotoxic, pregnancy can be allowed and subject can still be in trials but this will depend on study indication and if benefits outweighs risk to remain in study. Regardless of pregnant subject staying or discontinuing from study, she will be follow up to document the outcome of pregnancy . 

2. Hepatic, renal and cardiac monitoring:

Pragmatic monitoring of hepatic, renal and cardiac values instead of stringent baseline values has become acceptable. As liver diseases become common due to other diseases leading to liver dysfunction, patients recruited in clinical trials have already dysfunctional liver profiles at baseline. Even for kidney function tests choosing the right lab parameter to monitor i.e. instead of low GFR, sustained lower decline in GFR is more noteworthy to monitor in patients with kidney diseases. Cardiac functions are also important to be monitored as with more and more populations having some preexisitng cardiac dysfunction, excluding them is not the best outcome. So the organ toxicity identification and treatment has to be based on a baseline that considers this preexisting medical history and dysfunction. The duration of monitoring liver, renal, or cardiac enzymes, mechanism of action of the drug, study indication, and other risk factors should be considered when the safety team reviews and includes the about identification, monitoring, and treatment of liver dysfunction. Parameters and their clinical relevance for monitoring like AST, ALT, AST: ALT ratio, Serum bilirubin, GFR, Troponin, ECG Ultrasound are chosen in a way that makes the most efficient results when it comes to early identification and treatment for patients.

 

References:

1. FDA Website

2. Stanford Clinical trials

3. Treem, W.R., Palmer, M., Lonjon-Domanec, I. et al. Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis. Drug Saf 44, 133–165 (2021). https://doi.org/10.1007/s40264-020-01014-2

4. International consensus definitions of clinical trial outcomes for kidney failure: 2020Adeera Levin ,Rajiv Agarwal,William G. Herrington,Charu Malik, Vlado PerkovicInternational Society of Nephrology’s 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials

 Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me:ThinkSharp Foundation http://thinksharpfoundation.org/#home