Tag Archives: Clinical research organization

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

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