18+ SAMPLE Clinical Development Plan
What Is a Clinical Development Plan?
First of all, what is clinical development all about? Well, it is a collective term that is used to properly identify the entire process of introducing a breakthrough drug or medication device to the market. Clinical development consists of drug discovery and its subsequent development, the pre-clinical research phase which is accordingly done on microorganisms or animals, and the clinical trial phase which is done on humans. As it refers to introducing a new drug to the market, clinical development can also be called drug development.
A clinical development plan is an essential document that is needed whenever an intent to develop a new drug or medical therapy is introduced. It serves as the blueprint for a drug’s whole clinical research strategy. The clinical development plan defines the important route for the clinical program, including development evaluation and decision points, as well as project resources (such as people and money) estimations. Additionally, as more information becomes available from the results of studies, this document must also be accordingly updated and adapted.
Important Elements of a Clinical Development Plan
Listed and properly elaborated below are the main elements that have to be included in creating a clinical development plan:
Product Profile. This element may be defined even before creating the clinical development plan. When describing the product profile or product fact sheet, you need to include a thorough description of the drug product, the target population, the desired indications, and label claims of the drug product, as well as a market analysis of the competition.Background. This section of the clinical development plan discusses what is understood about the drug product, such as its mechanism of action and possible adverse effects. This section also discusses the drug’s target demographic, which serves as the foundation for clinical investigations.Planning. This component of the clinical development plan serves as the center since it is the path through which the drug’s qualities, such as its efficacy in the targeted site, benefits and hazards, and whether or not it has achieved proof of safety and proof of mechanism, will be examined. This section must offer a basic overview for each clinical trial proposed for the medicine, from Phase I through Phase III, with distinct research phases serving different goals and identifying the clinical outcomes for every study. In addition to the framework, this section of the clinical development plan must provide a time period for the trials.Deadlines and Milestones. This section of the clinical development plan acts as the go/no-go decision points, when a corporation must decide, as an example, if the risk/benefit ratio achieved in a trial is satisfactory to merit additional research and warrant market authorization, or if the project should be canceled entirely.Development Costs. This section of the clinical development plan discusses the estimated budget for the drug’s clinical research program. This estimate enables the organization to plan and adjust its assets and strategy as needed.Regulatory and Market Strategy. This section of the clinical development plan discusses the schedule in which the firm will contact regulatory authorities for guidance and permission, as well as which markets the company will seek to launch the product in. Various markets may necessitate particular studies, much as different populations may necessitate research into their genetic features or eating habits, for example.
Types of Clinical Research
Here are the different types of clinical research that are used by the researchers based on what they are studying:
Treatment Research. This type of clinical research usually comprises medical interventions such as medicine, psychotherapy, new equipment, or novel methods to surgery or radiation therapy.Prevention Research. This type of clinical research seeks improved strategies to keep illnesses from forming or recurring. Various types of preventative research may study drugs, vitamins, vaccinations, minerals, or lifestyle changes. In other words, it is intended to generate outcomes that are immediately useful to detecting and assessing risks, along with creating and testing treatments to avoid or minimize hazardous exposures, illness start, or disease progression.Diagnostic Research. This type of research refers to studies that seek to assess a test’s additional value beyond test findings readily available to physicians in diagnosing the presence or absence of a certain condition. In other terms, it may also relate to the process of seeking improved approaches to identifying a certain ailment or condition.Screening Research. This type of research aims to find the most optimal methods in detecting certain health conditions.Quality of Life Research. Quality of Life is a complex matter that is viewed and defined variously across professions, including health and medicine. This type of clinical research will have a look at different ways to increase comfort and quality of life for those who have a chronic condition.Genetic Studies. This type of clinical research looks for alterations in genes, chromosomes, or proteins. These seek to enhance disease prediction by finding and comprehending how genes and illnesses could be linked. This research may look at how a person’s genetics makes him or her somewhat prone to acquire a condition. This might lead to the creation of personalized medicines depending on a patient’s genetic makeup.Epidemiological Studies. Epidemiology refers to the study of how frequently and why illnesses occur in various groups of individuals. Epidemiological studies strive to uncover the trends, causes, and management of illnesses in populations. The data from such research is used to design and assess disease prevention efforts, as well as to guide the care of individuals who have already developed a disease.
Problems That Can Be Encountered During Drug Development
Clinical development is also known as drug development and often times it is not a very smooth process. Listed below are the various challenges that can be encountered during this process:
Absence of Expertise. Excellent business and managerial abilities are required for every project, particularly those involving drug discovery and development. In industrial contexts, a lack of expertise can result in research mistakes and delays, resulting in a large financial cost. Workplace scientists should have not just a broad variety of subject area expertise, but also experience aiding with the development and execution of toxicological and pharmacokinetic research.Rising Costs. Cost efficiency is a major concern in the pharmaceutical sector, yet it is notoriously difficult to manage. Medicine discovery and development may be an unpredictable and costly process, with each new drug requiring over a decade to create and only a tiny fraction of it that enter clinical trials getting authorized for launch. Nowadays, objectives have shifted away from mainstream outsourcing approaches towards insourcing teams to maximize laboratory space and resources without incurring excessive costs.Simultaneous Responsibilities. As numerous drug patents expire, organizations in the pharmaceutical industry confront an increasing need to replace important income sources with new treatments. This competitive climate necessitates a shared effort on discovering novel hits as well as developing new techniques to combat previously intractable targets. While traditional drug research outsourcing approaches help with the burden required in the drug discovery process, they can jeopardize intellectual property and boost total expenses.Hiring Limitations. Headcount constraints can be a problem for time-sensitive initiatives requiring a large number of scientists in a short period of time. Massive investments in breakthrough cures, such as new oncological medications, can strain research capacity, prompting organizations to seek further assistance. However, there are obstacles to overcome when partnering with or acquiring help from an external source, such as a limited number of institutions that are compatible with rules and a large number of institutes that are ill-prepared for research and development.Supply Shortages. Drug research and development have been hampered by shortages of active pharmaceutical components and disruptions in the pharmaceutical supply chain. Furthermore, prescription demand continues to fluctuate internationally. Various unprecedented changes in the drug supply chain necessitate a greater need for agile support to enable a quick shift in focus.
Steps of Clinical/Drug Development
Clinical development has become a complex process throughout the years, requiring more and more testing phases before getting approved. The process of clinical development involves a number of critical steps. all of which will be discussed accordingly below.
1. Discovery and Development Phase
This is the first step of the clinical development phase. This step comprises screening hits, medicinal chemistry, and hit optimization to eliminate possible drug adverse effects and thereby increase affinity and selectivity. It also entails high-throughput screening, hit-to-lead operations, and lead optimization procedures. This stage of the medication development process also improves effectiveness or potency, metabolic stability (half-life), and oral bioavailability. The process of drug discovery concludes when one lead chemical for a candidate drug is discovered, and the drug development phase begins.
2. Preclinical Research
After the discovery and development process, this step then follows. The preclinical research phase involves testing to establish the medicine’s effectiveness and safety. The researchers assess the drug’s potential advantages and methods of action, ideal dose and delivery route or routes, adverse effects, interactions with other medicines, and efficacy when compared to similar medications in this phase. The medicine is next tested on non-human subjects to determine its effectiveness, toxicity, and pharmacokinetics. Scientists undertake these experiments in vitro (externally) and in vivo (internally) with unlimited doses.
3. Clinical Development/Clinical Trials
After the preclinical research phase, this step then follows. This step usually involves the clinical trial phase to finetune the drug in order to make it suitable for human consumption or use. It should be noted that the trials need to be safe and must be completed using the given budget and also using an approved methodology to confirm that the drug works properly within its intended objective. Additionally, the clinical trial phase must be rigorous, set up correctly. and take in plenty of participants to improve the study’s effectiveness.
After the clinical development/trial phase of the new drug, and once the results have been confirmed or finalized, a review then follows. A review is usually performed by a higher governing body such as the FDA. In FDA’s case, in this process, they either approve or disapprove the application that is submitted by the drug company. The timeline may be standard or fast-tracked depending on the applications and how important is it to get patented immediately. Sometimes, new medications may be approved more quickly if there is substantial evidence of a favorable impact on a surrogate goal rather than proof of an impact on the real therapeutic benefits provided by the treatment. Having a drug approved more quickly can mean that there is a possibility that it can cure more severe health conditions. Applications can also fail, however, if the performance is proven to be inadequate or if it is too toxic.
Once a new drug gets approved and once it has been manufactured, this step then follows, which is called the monitoring phase. The monitoring is usually done through the use of a database called the adverse event reporting system database. This database assists the regulatory agency in implementing its post-marketing safety monitoring program. Various manufacturers, health professionals, and consumers can then use this program to report concerns with licensed pharmaceuticals.
Orphan Drugs can also be developed during the clinical development process. What is it?
An orphan drug is a pharmacological agent created to treat medical problems that would be unprofitable to produce without state funding. The disorders that orphan drugs treat are known as orphan diseases. Patients suffering from rare diseases that must be treated with orphan medications must be kept up to date on scientific and therapeutic advances and they must be entitled to the same level of treatment as any other patient. Incentives for the health and biotechnology sectors have already been created to boost research and development in the field of orphan pharmaceuticals.
Drug delivery methods, such as topical delivery, are analyzed in the clinical research phase of clinical development. What is a topical delivery method?
Topical drug delivery refers to formulations such as ointments, creams, lotions, or transdermal patches that transport a medication into the body by absorption. Topical administration is more beneficial for a patient’s skin or muscle disorders, and patients prefer it since it is non-invasive and allows them to self-administer the drug.
What is the role of the FDA in clinical/drug development?
The role of the FDA in clinical development is that they are the ones who are interpreting laws, rules, and regulations and distributing policy pronouncements that would otherwise be confusing. The FDA also directs medication development through advisory committee meetings which can be confidential or open. These meetings help the regulatory review and approval process by introducing together specialists to assess data, recommend the need for new studies, and address relevant questions formulated by the FDA to assist in resolving scientific or clinical issues related to the drug development phase or a specific product approval.
As stated earlier, a carefully planned and created clinical development plan serves as the foundation of effective clinical development, carefully lays out the entire development life cycle along with its subsequent goals, clearly states what types of documentation is needed for each of the development stages, and most of all serve as a vital paper when a company tries to develop and introduce a new form of therapy or drug to the public. When developing one, it should be noted that it needs to be adaptable as new facts emerge over the course of the clinical development process. In this article, blank templates of a clinical development plan are readily available to you so that you have a reference to use when you need to make one.