How to avoid delays in Clinical Trials?

As we know clinical research is a field that deals with Phase 0 to Phase IV clinical trials. Each phase has its own objective and end points. These contribute to expensive clinical research.  A majority of clinical research  results in delays,  which could be of few months. So it has  impact on time, money as well as on patients also. It has been estimated that 85% of clinical trial project get delayed due to one reason or other. The financial impact can be huge in the tunes of $ 8 million every day.

The most common delays are site initiation delays. These could be due to ethics committee delays. So whenever one should submit its documents to IEC, he should make sure that it is accurate and complete. Any discrepancy in these documents can lead to delay in minimum of one month or so.

Site initiation visit are very crucial visits and that should be done very carefully. But any delay or postponement in SIV will further lead to delay in the project. So as soon as IEC approval of the product is given, SIV should be done on immediate basis without any delay.

Patients should be given proper check up and informed consent form. Patient should be  given  proper informed consent that means that he should be informed about the study in lay man language, with proper time to think  and take his own decision whether to participate in the study or not. Once patients has been enrolled for the study then it the responsibility of Clinical Research Coordinator to follow up with study patients constantly so that patient feels safe and secure and come for the regular follow up on timely basis.

Every member of staff should be armed with the correct policies and procedures – as well as fully calibrated and ready equipment – to   commence research activities on the site initiation visit (SIV) date. False starts due to missed SIV dates have an immediate impact on trial timelines and, ultimately, profitability for sponsors.

A huge majority of clinical trials face delays, costing precious time and money, as well as impacting patients. Here is why managing time, resources and participants are essential in avoiding delays and delivering results.

An estimated 85% of all clinical trials will experience delays, with 94% being delayed by over a month.¹ The financial impact can be massive, costing between $600,000 – $8 million every day.²

Besides the immediate impact on clinical trial budgets, delays can impact the long-term profitability of a drug by reducing its patent window. Estimates vary, and are contested, but whether measured in pounds, euro or dollars, the amount of money lost in clinical trials delays is in the billions, and increasing year on year.^3,4

While it’s important to recognise the financial implications of delays, there are some human implications too. Hold ups may place an unnecessary and unwanted burden on patients, which could lead them to exit trials, further exacerbating the problem. And delays in getting drugs to market means delayed treatments, potentially effecting patient outcomes.

We explore some of the common reasons why clinical trials experience delays, and what you can do to avoid them.

Damaging delays

A Nature analysis examining the causes of clinical trial delays found that strategic problems, commercial barriers, and operational issues were to blame in almost a quarter of all trials.⁴

Similarly, increasing complexity, and interdependencies between agencies and across borders, puts greater demands on project managers to meet deadlines. In recent times, end points in trials have doubled, with the average number of procedures per participant increasing by 58%.⁵

Frustratingly, site initiation delays are common. Every member of staff should be armed with the correct policies and procedures – as well as fully calibrated and ready equipment – to   commence research activities on the site initiation visit (SIV) date. False starts due to missed SIV dates have an immediate impact on trial timelines and, ultimately, profitability for sponsors.

Once a trial is underway, the most common reason for delay is the complex and challenging area of patient retention and recruitment, with many studies failing to recruit in adequate numbers. A study by CenterWatch claims that 69% of patients fail pre-screening, 58% decline consent and 8% drop out after enrolment.⁶

The importance of site selection is becoming clearer, with researchers adopting a more ‘patient-centric’ approach where the patient’s point of view is clearly considered.⁷ Having processes in place to receive notifications of poor uptake, and approaches to ameliorate the impact is essential.

A ‘business approach to clinical trials

The complexity of clinical trials has increased, and this calls for more robust and standardised clinical research procedures.^8,9 Researchers are being encouraged to take a commercial ‘business approach’ to project management. To help adopt this approach, Imperial Clinical Research Services have created a useful and in-depth guide for clinical professionals on project management.

Similarly, having a tool like a commercial clinical trial management system (CTMS) can help. A CTMS can provide a rigorous and methodical approach to preparing all documents, policies and procedures to support your research, locate them all in one place and help you to manage time effectively.¹⁰

However, it’s not just processes that need improvement. Ensuring that clinical research sites are ready to begin receiving patients by the site initiation visit is essential. At MESM, we can work across all of a customer’s study sites to ensure the ancillaries and equipment meet protocol requirements and are ready to use before the trial begins.

Running a clinical trial is complex, but Claudia Schaft at the European Project and Research Office has four simple tips for minimising delays:

• Start work immediately: Be proactive in managing potential delays
• Revisit site assessments regularly: Review all procedures and processes
• Be adaptable: Review your project management approach, and change if necessary
• Build relationships: A responsive project management team needs responsive relationships

Delays in clinical trials are common, but not unavoidable. By understanding the potential risks – and putting processes in place to combat them – your trial can be a success both for the sponsor and the patients taking part. And all within trial budget too.

Clinical trials are the ‘gold standard’ in clinical research and provide information on the safety and efficacy of a product in humans. Clinical trials are an essential part of modern medicine, and they are used to evaluate new treatments and therapies. In recent years, there has been an increase in the number of clinical trials conducted on herbal and ayurvedic products. Herbal and ayurvedic products have been used for centuries to treat a variety of conditions. However, there is limited scientific evidence supporting their efficacy. These trials have many advantages, including the following:

Safety and Efficacy

Clinical trials are studies that test the safety and effectiveness of new drugs or therapies in humans. Many people turn to herbal and ayurvedic products as an alternative to conventional medicine.  Clinical trials can provide data that supports or refutes the effectiveness of these products, which can help consumers make informed decisions about their health.

Standardization

Clinical trials can also provide valuable data on the underlying mechanisms of action for herbal and Ayurvedic products. It helps in the standardization of herbal and ayurvedic products which can be challenging to standardize because they often contain multiple active compounds. Clinical trials can help standardize the dosage and composition of these products, which can improve their consistency and reliability.

The Competitive Edge

Clinical trials of Herbal and Ayurvedic can give a product a competitive advantage over similar products that do not have clinical data supporting their safety and efficacy by providing objective evidence of the product’s safety and effectiveness, which can increase consumer confidence in the product. In some cases, clinical trials compare a product with another that already exists to determine whether the new one is at least as good as the existing one. This comparison can help establish the product’s superiority over similar products, which can be a key factor in differentiating it from competitors in the marketplace. This information can then be incorporated into the labeling of the product to provide healthcare professionals and patients with a better understanding of its benefits and potential risks.

Promotional Advantage

Ayurvedic and Herbal companies can highlight the clinical trial data in their promotional materials; companies can differentiate their products from competitors and help build consumer confidence in their brand. In addition to traditional advertising and promotional materials, companies can also leverage social media and other digital marketing channels to promote their products and share clinical trial data with consumers. For example, a company can use social media to highlight key study results in a visually engaging way. However, it is important to ensure that all advertising and promotional materials are truthful, balanced, and in compliance with regulatory guidelines.

Collaborative Research

Clinical trials for herbal and ayurvedic products often involve collaboration between Western and Eastern medicine. This collaboration can lead to a better understanding of the products and their potential benefits. Collaboration can also lead to new insights into the development of safe and effective therapies that combine Western and Eastern approaches. Collaboration will improve the quality of research, increase the number of studies performed on herbal medicines, and provide more evidence to support their use in clinical practice.

Despite not being under the purview of the regulatory authorities, clinical trials for herbal supplements and ayurvedic products would help substantiate claims of health benefits, facilitate product differentiation in the market and allow for their use as medicinal products with proven efficacy. Furthermore, clinical studies would help support manufacturers who perform them a significant advantage over the ever-increasing competition. Safety and toxicity concerns are often associated with ayurvedic and herbal supplements due to their complex nature and thus clinical trials are necessary to ensure safety to consumers.

The herbal and ayurvedic product market continues to grow exponentially, and Pharma Instinct’s team is at your side to help you take advantage of this growth. Our experts are here to help you understand your requirements and provide solutions in accordance with regulatory requirements.

Important points for Sponsors to have meaningful relations with Site

Sponsor can create of positive relationship with site and that from the onset itself. This may include study design decisions and execution decision that reduces operational hiccups, prevent protocol amendments and decreases burden in particular on site. To make efficient trials, sponsor should aim for building good relationships with investigators to collaborate. Although starting and then nurturing Sponsor Site relationship  can be difficult assignment because of  increased competition.

The important points to built meaningful relation with sites could be

• To keep hospital supplies and IP ready so that whenever there is any enrollment it should not be rejected because of hospital supplies and IP
• Training is important part of GCP, It gives to confidence of handling the project as per guidelines. But repeat trainings can be dangerous, so only those who lack in training should be given training on GCP, SOPs, Regulatory guidelines etc.
• One of the important binding between sponsor and PI is distribution of the funds. So, Once you have signed document of financing the research project, then milestone must be match and funds must be released on time to time basis.
• One of the possible causes of good relationship is to have minimum protocol amendments. Any alteration in protocol can be a tedious task so keep it as low as possible.
• Monitoring should be done as it rule out the protocol changes. The best way to do monitoring is to inform in advance of monitoring date and then CRA comes for monitoring. Site close out visit should also be informed and should be done very carefully so that data collected to accurate.
• Data analysis is crucial component of Clinical Trials. Entries must be checked in the software for their accuracy and correctness. Each entry must be correct and statistical analysis should be accurate.

By doing some of the above things sponsor and investigator can have a good relation for clinical trial.

As the population is increasing day by day, so does the diseases, and thus the need for a cure is also increasing. And this is the scenario of almost all the countries in the whole world. In earlier times, doctors relied on their education and experience to take care of their patients. But with time, as more drugs and therapies are introduced, doctors needed to find a way to compare the medications and see which treatment worked better to cure a particular illness and disease. This emergency got resolved by the emergence of clinical trials during the mid-20^th century.

Medicines are not made in a day. It includes long procedures for days, months, or even years and researchers with full dedication. Even after it is made, it does not go directly into the hands of needy people, rather it is tested very rigorously to know if it is safe and is really advantageous for the population that needs it. And the most important step to study the safety, efficacy, and side effects of a new medicine is carried out by clinical trials. Through the trials, researchers investigate medication efficacy, side effects, dosing, potency, and drug impact on the population. Clinical researchers closely monitor the participants for punctilious document finding which is irreplaceable in the drug approval process from the FDA and is mandatory before releasing any medication to the general public.

Clinical trials are very crucial for drug development and improvement of human health and clinical study outcomes are unpredictable. Researchers may have tested similar drugs and formulated hypotheses, but they can never know the effects of a treatment or medication without conducting studies. Along with testing new drugs and devices, the clinical trials also provide treatments to the patients on scientific basis. Clinical trials help to determine whether new medicine or treatment developed in the laboratory or by using animal models are safe or effective or whether any newly developed diagnostic test will work properly.

Advantages of Clinical Trials

• Clinical trials improve health care services by raising the standards of treatment
• Clinical trial leads to new treatments, which in turn helps people to live longer and to live a life with less pain or disability.
• Clinical trials allow testing as well as monitoring the effect of a medication or treatment on a large population to ensure that the improvement as a result of any medication or treatment is not for only one person but is for a large number of people.
• Researchers are not always lucky to obtain outcomes they predict, but the trial results still help the scientists to move in the correct direction.
• Clinical trials let the researchers to compare treatments that allow deciding which one is better for the patients.
• Participants get access to promising new treatments which are not available outside the clinical trial boundaries.
• Participants get the chance to be the first to get benefit from a new method under study.
• Participants get the chance to play an active role in their own health care and clearly understand their disease or condition.
• Participants are closely monitored, advised, cared and supported by a research team of doctors and other health care professionals
• Participants get the opportunity to help society by contributing to medical research.
• Even if the participants are not directly benefited from the clinical trial, the information gained and gathered add up to the scientific knowledge and may be helpful for others.
• Clinical trials can be a valuable treatment alternative, especially for patients with advanced or hard-to-treat diseases like cancers that have not responded to previous or current treatments.

Disadvantages of clinical trials

• There may be side effects
• The new treatment may not be better than the standard treatment
• The trial site may not be available at a convenient location.
• The clinical trial duration may be more than the non clinical trial treatments like hospital stays, more clinical trial site visits etc.

Clinical trials have more advantages in comparison to the disadvantages and the modern medical treatments for diseases like cancer, cardiac disease, asthma, high blood pressure, and many other medical conditions have been developed through clinical trials.