All posts by Pharma Instinct

CLINICAL TRIALS AND HEALTH CLAIMS

RESEARCH-BASED HEALTH CLAIMS HELP THE COMPANIES TO BUILD THEIR BRANDS, AS THEY ARE MORE TRUSTED BY THE CONSUMERS.

Health claims are the declarations made by the companies about their products (such as pharmaceutical products, dietary supplements, herbal products, ayurvedic products, nutraceuticals, etc) on the basis of scientific research.

As the consumers play a major role in providing strength to the product, it clearly needs to gain the trust of the consumers. This can be accomplished by generating research evidences and building health claims.

From ingredients of the product to its health benefits, claim can be made for anything through Clinical trials. Besides clinical trials, the animal studies (preclinical studies) also help to support the health claim. The claim for a product can be placed under any of the field given below:

  • Functional claims: This claim is related to the beneficial effect of the product on the normal well-being of the person. But one cannot claim for the treatment of a specific disease. These claims just include the effect of the product on physiological and psychological health of the humans.

For example, as observed from a clinical trial, specific nutrients of a food product (which have been studied) have the capability to provide growth and energy to a person.

  • Therapeutic claims: These claims include the effect of a particular component of the product (bioactive component) in treating a disease, as proved by a clinical trial. These claims show the direct link between bioactive component of the product and its therapeutic effect on the body. So, clinical studies providing proof for therapeutic effect of the product help to openly claim for the efficacy/safety of the product in humans to treat a disease.

For example, one can claim that your anti-diabetic product is highly effective in treating diabetes as it has been proved in a clinical study on diabetic patients.

  • Disease risk reduction claims: It is common in these days that the unhealthy dietary habits lead to the increase in risk of a specific disease. But, during a clinical study, if a product has been proved that its components are very healthy to be consumed or they do not increase the risk of diseases, then, it can be claimed openly for the product.

For example, by doing clinical study, you can claim that your product is either rich in some nutrients or specific bioactive components which help to lower the risk of a disease or you can also claim that your product is free of some unhealthy components (such as unhealthy fats) that it can help to lower the risk of heart disease. All these kind of claims are covered under this category of ‘disease risk reduction claims’.

  • General health claims: The products can also be claimed for their consumption in healthy manner or according to a specific dietary guideline which can be generated by doing clinical trials on that product. Clinical trials help to evaluate these dietary guidelines or pattern to consume the product.

For example, you can claim that your food supplement will give its maximum effect if it is consumed once, twice or thrice in a day (depending upon the results of your clinical study).

Validated scientific proofs help to advertise or market their product under any of the claim listed above. You can advertise your product with a specific claim if you have scientific proof for it. Once you have done clinical trial for your product, you can claim it, market it, advertise it and you can also label it with the claim.

The research data can  be  published  in National and International Journals of high impact. Claimed products with research articles also attract the attention of the doctors & give him confidence to prescribe the product. More is the prescription of product more will be the awareness about the product & better accepted it will be by the the doctor as well as end consumer.

References

CRITICAL POINTS OF CONDUCTING DERMATOLOGY CLINICAL TRIALS

 

ACCURATE & RELIABLE CLINICAL TRIAL DATA ESTABLISHES & ENHANCES BRAND VALUE

Clinical trials are essentials for making Health Claims. Ranging from regular fever to complicated diseases like cancer, clinical research has established many treatments. On the same ground, clinical trials also have roots in the field of skin care and hair care.

Skin care and hair care market has grown many folds and the end consumer is quite aware these days. Not only doctors, regulatory authorities but consumers also look for efficacy & safety data of each product. Consumer wants to be sure before making the choice for any products. Correct & Accurate Clinical Trial data helps in building faith of the consumer about the product thus helps in establishing the Brand.

While planning for clinical studies for skin care & hair care products, the study design should be meticulously planned so that the data generated is accurate, analyzed correctly & presented in a beautiful manner. It must be publishable in International Journals of good reputation.

Some of the critical points which should be considered while designing the clinical study. These are:

  • Well-designed Clinical Trial Protocol: The protocol for the clinical study related to skin or hairs should be completely informative. All the investigations to be done, patients to be enrolled, type of medication to be given, etc, should be given in detail.
    • Categorization & differential diagnosis of disease condition is very crucial.
    • Study end points must be clearly defined
    • Patients with chronic skin disorders must be screened & enrolled very carefully keeping study inclusion & exclusion criteria in mind.
    • Proper lighting, appropriate patient positioning and prior facial skin preparation (gentle shaving for men, removal of make-up for women) are helpful in facilitating accurate assessment
  • Clinical photography: In the dermatological studies, as the studies are related to skin & hair problems, so symptoms are required to be clearly indicated. Due to this, the clinical photography is mandatory, either from smart phone or from camera. This will help in evaluating the results and difference in the condition of the patient before and after giving dosage during clinical trial. Photographs should be taken only after the patient’s consent and in accordance with the general medical guidelines.
  • Dermatologist: Always assign a well-experienced dermatologist as Principal investigator in the clinical trial. The dermatologist should be able to evaluate the visible signs over the skin or hairs of the patients.
  • Laboratory investigations: The diagnosis of the condition of patient with dermatological diseases should be accurately observed with all the biochemical, hematological, microbiological and histopathological tests.
  • Patient privacy: Privacy of the patient should be maintained while dressing, undressing, medical photography, examinations, etc.

References

FDA’S VIEWS ON COMMUNICATIONS ABOUT MEDICAL PRODUCTS

Looking at the need for randomized clinical trials to ensure the safety and efficacy of new medical products and added indications, FDA released two separate draft guidance that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products. These draft guidance are:

I.    Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities – Questions and Answers

This first draft guidance explains the FDA’s current thinking and recommendations on firms’ communication of health care economic information (HCEI) about approved drugs. It also answers common questions and provides the FDA’s recommendations regarding firms’ communications to payors about investigational drugs and devices that are not yet approved or cleared for any use.

Payors include formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis that are responsible for making drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis regarding drugs and/or devices for health care organizations, which may include entities such as integrated health care delivery networks, hospitals, and hospital systems.

FDA is aware that payors seek a range of information on effectiveness, safety and cost-effectiveness of approved drugs, including information from firms, to help support their drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis.

Because coverage and reimbursement decisions by payors impact a large number of patients, FDA believes it is essential that HCEI provided by firms to payors about their approved drugs be truthful and non-misleading.

II.  Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers

This second draft guidance explains the FDA’s current thinking about firms’ medical product communications that include data and information that are not contained in their products’ FDA-required labeling, but that concern the approved or cleared uses of their products.

This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively “firms”) of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively “medical products”), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product.

FDA determines whether a medical product is safe and effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling submitted to FDA with the product’s marketing application or submission. In making this determination, FDA evaluates whether the conditions of use in the proposed labeling are supported by the required levels and types of evidence of safety and effectiveness and whether the benefits of using the product under those specific conditions of use outweigh the risks of the product.

After FDA approves or clears a medical product, the FDA-required labeling sets forth the conditions of use under which the product has been shown to meet the relevant standard for marketing and it provides directions and information on how to use the product safely and effectively under those conditions.

Even if a communication is consistent with the FDA-required labeling, the representations or suggestions made about the product would misbrand the product and could subject firms to enforcement action if the representations or suggestions are false or misleading. Accordingly, the draft guidance both describes FDA’s thinking on the types of information that are consistent with the FDA-required labeling and provides general recommendations for how this information can be conveyed in a truthful and non-misleading way.

REFERENCES

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537371.htm
https://www.federalregister.gov/documents/2017/01/19/2017-01011/drug-and-device-manufacturer-communications-with-payors-formulary-committees-and-similar
https://www.federalregister.gov/documents/2017/01/19/2017-01012/medical-product-communications-that-are-consistent-with-the-food-and-drug-administration-required
http://www.appliedclinicaltrialsonline.com/fda-highlights-importance-confirmatory-studies-0

OBESITY RESEARCH WORK PUBLICATION AND RELATED JOURNALS

 

Obesity has risen to epidemic levels in many countries. It causes many health-related problems which reduce life expectancy and causes stigma & discrimination in the suffering individuals. To contribute in minimizing such prevalence, knowledge about obesity should be spread as much as possible in effective way. There can be two ways through which an attempt can be made to tackle the problem such as

Continued efforts of government and other organizations which will be valuable toward reducing obesity, so that people can look forward to healthier lives

Recent scientific discoveries & new efforts should be made public to better understand the factors contributing to obesity and to design and test strategies for prevention and treatment.

Journals & publications contribute well towards spreading knowledge about any scientific discovery. These research publications can be selected for increasing knowledge on the basis of various factors such as journal name, impact factor etc. Journals with higher impact factors are often believed to be more important than those with lower ones.

Specifically in the field of obesity, the aim of the obesity research journals is to provide rapid and reliable source of information about obesity and associated areas of obesity in the mode of original articles, review articles, case reports, short communications, etc and making them freely available through online for researchers & general population.

For researchers, research publications provide honor for the authors if they publish their work, provide a mode of initiating research for other scientists and make them linked with the recent advancements in the specific field.

For general population, research publications help them to pursue research in academic area and provide an approach for gaining information about specific disease to treat & prevent the disease themselves.

There are some journals which can be chosen by researchers & general population for accessing & submitting research publications. These journals specifically related to obesity are:

 

Journal of Nutritional Disorders & Therapy (https://www.omicsonline.org/nutritional-disorders-therapy.php)(Impact Factor: 0.81)

International Journal of Obesity (http://www.nature.com/ijo/index.html) (Impact Factor: 5.337)

Obesity: A Research Journal (http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1930-739X) (Impact Factor:3.614)

Obesity Surgery (http://link.springer.com/journal/11695) (Impact Factor: 3.346)

Obesity Reviews (http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1467-789X) (Impact Factor: 7.51)

Diabetes, Obesity and Metabolism (http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1463-1326) (Impact Factor: 6.198)

Surgery for Obesity and Related Diseases (https://www.journals.elsevier.com/surgery-for-obesity-and-related-diseases) (Impact Factor: 3.540)

Current Opinion in Endocrinology, Diabetes & Obesity (http://journals.lww.com/co-endocrinology/Pages/default.aspx) (Impact Factor: 3.119)

Pediatric obesity (http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)2047-6310) (Impact Factor: 3.689)

Obesity Facts (https://www.karger.com/Journal/Home/233731) (Impact Factor: 2.4)

CAUSES OF OBESITY

Vitamins & Minerals (https://www.omicsgroup.org/journals/vitamins-minerals.php) (Impact Factor: 0.5)

Anatomy & Physiology: Current Research (https://www.omicsonline.org/anatomy-physiology.php) (Impact Factor: 0.86)

Journal of Obesity & Metabolic Research (http://www.jomrjournal.org/)

JOURNAL OF DIET AND OBESITY

Journal of Clinical Nutrition & Dietetics (https://clinical-nutrition.imedpub.com/)

Bioactive Carbohydrates and Dietary Fibre (https://www.journals.elsevier.com/bioactive-carbohydrates-and-dietary-fibre/) (Impact Factor: 0.822)

Journal of the Academy of Nutrition and Dietetics (http://www.andjrnl.org/) (Impact Factor: 3.609)

Journal of Human Nutrition and Dietetics (https://www.bda.uk.com/membership/publications/hnd_journal)

World Review of Nutrition and Dietetics (https://www.karger.com/BookSeries/Home/223966)

Canadian Journal of Dietetic Practice and Research (http://dcjournal.ca/journal/cjdpr) (Impact Factor: 0.769)

Nutrition and Dietetics (http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1747-0080) (Impact Factor: 0.899 )

JOURNAL OF SEDENTARY LIFESTYLE AND EXERCISE TRENDS

Journal of Obesity & Weight Loss Therapy (https://www.omicsgroup.org/journals/obesity-weight-loss-therapy.php) (Impact Factor: 0.752)

International Journal of Sport Nutrition and Exercise Metabolism (https://www.researchgate.net/journal/1526-484X_International_journal_of_sport_nutrition_and_exercise_metabolism) (Impact Factor: 1.08)

JOURNAL OF WEIGHT LOSS MEDICATION

Advances in Weight Loss Management & Medical Devices (https://www.omicsonline.org/advances-in-weight-loss-management-medical-devices.php)

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy (https://www.dovepress.com/diabetes-metabolic-syndrome-and-obesity-targets-and-therapy-journal)

Journal of Diabetes & Metabolism (https://www.journals.elsevier.com/diabetes-and-metabolism) (Impact Factor: 4.693)

International Journal of Eating Disorders (http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1098-108X) (Impact Factor: 4.068)

 

Obesity Clinical Trial Critical Points

Obesity Clinical Trial Critical Points

Obesity is a one of the most prevalent health problems and new treatment strategies are developing at a very fast pace.  Looking at the market size of anti-obesity products, many anti-obesity agents are developed by Pharmaceutical and Food companies. These products have to undergo pre-clinical & clinical development process to establish it safety & efficacy for human use.

There are various strategies to treat obesity which include

 1) Appetite controlling

 2) Inhibiting Fat uptake

It becomes all the more important that the study protocol & its outcome must have clarity about the mechanism of the anti-obesity investigational product. Some of the following critical points one should keep in mind while designing its protocol

  • For clinical trials of anti-obesity agents it becomes all the more important to have standardised protocol and meaningful end points.
  • There should be clear instructions regarding diet, exercise, and other behavioural regimens.
  • Lifestyle modifications are must for management of obesity and the clinical study protocol must have details of lifestyle counselling and their compliance during the study period. Lifestyle counselling by dietician or health educator can add huge value to the study outcome and can benefit the sponsor.
  • In obesity trials, the sequence of the food, like protein before fat and carbohydrate or vise-versa can change the outcome of the study and can impact product efficacy in a huge manner.
  • Exercise such as walking and cycling extra can be added to study protocol.
  • Frequent follow up with patient is important for better compliance of the patient. Initially every two week follow-up and than once four week follow up is recommended for long term anti obesity studies.
  • Subjects to be enrolled for initial clinical trials should have a BMI of 30 without co-morbid diseases.
  • Subjects with histories of anorexia nevosa or other extreme eating disorders should be excluded.
  • Age range should be as wide as possible.
  • Prior use of anti-obesity agents should be documented, and a subject should have been off any anti-obesity drug for at least 6 months.
  • Subjects should have had a stable weight with changes of ~3 kg in the last 3 months to 6 months.
  • Weight loss should be the primary outcome.
  • Cardiovascular risk factors, such as blood pressure, serum glucose, lipids, uric acid, and other measures should be assessed as secondary outcomes.
  • Dropouts should be minimised by appropriate strategies built into the protocol.

CLINICAL TRIAL: RIGHT PATIENT RECRUITMENT

CLINICAL TRIAL: RIGHT PATIENT RECRUITMENT

Clinical trials are the research studies which are performed on the human beings, either healthy volunteers or diseased patients. Each clinical trial is done to answer the scientific questions and to find out the better ways to prevent, diagnose or treat a disease, syndrome or disorder and also to compare a new treatment with that which is already available and is in use. For the successful conduct and completion of a trial, patient recruitment is critical and challenging step. Without patients, clinical research doesn’t happen. Medical advances depend on their participation. Sometimes due to the following mistakes, patient recruitment get affected that results in delay in the completion of the trial, thus also affecting the CRO’s and Sponsors relationship. These mistakes along with steps to correct them are given below:

Complex Protocol

Complex protocol is one of the reason that participants refuse to participate in the study. Protocol preparation is the first and critical step in the designing and conduct of clinical trial. If the protocol is too complex then the study won’t apply to a significant portion of the patient population. Complexity in the protocol can cause confusion for study subjects and if people will not understand the protocol, they would not like to participate, no matter how beautifully the things are designed or executed. So the protocol must be simple and should be designed by incorporating the patient’s perspective, to promote enrollment and realistically reach the available population.

 Incomplete information

Incomplete information in the recruitment material (ICF (Informed Consent Form), CRF (Case Record Form) etc.) is another cause. If the recruitment material doesn’t reflect the motivations of participants, then people would not like to participate. The person dealing with people or patients should know that why people do and don’t enroll for clinical trials. Recruitment materials should reflect the intent of the study.

Research Specifications of Inclusion and exclusion criteria

A common mistake is the lack of research subject specifications i.e. inclusion and exclusion criteria. These criteria helps other researchers to understand that why current results might differ from other published studies. For example specify the gender, parameters to assess for screening etc.With too many inclusion/exclusion criteria requirements, willing people often are not able to participate because they don’t qualify. So the subject specifications must be clear, needful and related to the study only.

Awareness about clinical trials

Lack of awareness about clinical trials among the people may be one cause that they don’t participate in the study. If more people know about clinical trials, then there would certainly be more participation. So, it is important to educate the people about the clinical trials through pamphlets, brochures, media etc.The encouragement from physicians, pharmacists, family, friends and others can influence the decision of the people to participate.

Uncertainty about Patient Safety

Fear about the outcome of the study may also force the people not to participate in the study. Unknown outcomes, uncertainty if a new treatment can help them, being experimented on, possible side effects and receiving a placebo instead of an actual treatment are a few common fears of the people. As the patient safety is priority, so by ensuring the patient safety, one can motivate the people to participate in a trial.

Communication between Participants & CRC

Lack of communication between the participant and the person dealing with participant is also one reason. It’s also important for the CRC or PI to be prepared to answer the questions that result from the promotion of study materials. If the person dealing with the subjects (PI (Principal Investigator) or his designee, CRC (Clinical Research Coordinator) etc.) would not be able to answer or clarify the doubts of the people, then they won’t participate in the study. So PI or CRC should have the complete knowledge about the trial and should be able to clarify the participants doubt. CRC must inform the participant about the follow-up visits and should take the feedback from the participant on each follow-up, about any side effect, if they felt.

Inability to track the results may be the one of the biggest mistakes that can be made in patient recruitment.It’s important to ask each participant that how they heard about the study. Sites can use metrics and analytics as hard data to justify why they need an increased advertising budget. So by analyzing what was effective and what didn’t work, helps to plan future recruitment, knowing what to continue doing and what to do to avoid making the same mistakes.

References:

https://medlineplus.gov/clinicaltrials.html

http://www.centerwatch.com/clinical-trials/overview.aspx

http://www.sciencedirect.com/science/article/pii/S188319581000112X

http://forteresearch.com/news/recruitment-efforts-fail-enroll-enough-patients/

http://forteresearch.com/news/patients-enroll-clinical-trials-others-dont/

https://www.nimh.nih.gov/health/trials/index.shtml

Clinical Research Basics

Clinical trials are a part of clinical research. They look at new ways to prevent, detect or treat new diseases. They are designed to answer specific questions about biomedical or behavioral interventions. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Goal of clinical trials: The goal of clinical trials is to generate data on safety (whether the drug is safe enough) & efficacy (whether the drug works well enough) of the tested drug (originated by sponsors) in humans.

  • The sponsor, who has developed new drug, could be a governmental organization or a pharmaceutical, biotechnology or medical device company.
  • Clinical trials are conducted only after the sponsor has received health authority/ethics committee approval in the country where the trial is going to be conducted. These committees are responsible for testing the risk/benefit ratio of the trial. Their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.
  • Depending on the product type and development stage, investigators (doctors) initially enroll volunteers or patients into small pilot studies and then, conduct progressively larger scale comparative studies. Volunteers for the clinical trials are not paid for participating. They participate in clinical trials for a variety of reasons such as,
    • Healthy volunteers participate to help others and to contribute to moving science forward.
    • Patients participate either to help others or to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
  • Clinical trials can vary in size & cost and they can involve a single research center or multiple centers, in one country or in multiple countries.
  • Clinical trials are conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participant’s health and answer specific research questions. A protocol describes the following:
    • Who is eligible to participate in the trial
    • Details about tests, procedures, medications and dosages
    • The length of the study and what information will be gathered
  • Clinical trials involving new drugs are commonly classified into four phases.
  • Phase I trial: Researchers test an experimental drug or treatment in a small group of volunteers (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
  • Phase II trials: The experimental drug or treatment is administered to a larger group of patients (100–300) to determine its effectiveness and to further evaluate its safety.
  • Phase III trials: The experimental drug or treatment is administered to large groups of patients (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments and collect information that will allow the experimental drug or treatment to be used safely.
  • Phase IV trials: After the drug is approved by FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

While starting a clinical trial, investigator recruits patients with the predetermined characteristics, administer the treatment and collect data on the patient’s health for a defined time period. Researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests.