A Not-So-Secret Formula: Organic Formula Trial

A Not-So-Secret Formula: Organic Formula Trial

Enhancing recruitment for an organic infant formula

Overview 


In early 2021, a customer tasked Acclinate with helping them recruit participants for an organic infant formula trial. Again, diversity was essential to the primary investigator and executive leaders. However, the customer’s decentralized trial suffered low participation, despite traveling nurses available in 12 different large cities at the time.


The customer anticipated difficulty recruiting diversely from their target demographic: pregnant women due less than two weeks after enrollment. 


In addition, the large trust gap between communities of color and the healthcare industry made diverse recruitment even less likely.


Solution


Acclinate proposed a pilot program to assess and improve the customer recruitment process. With Acclinate’s targeted engagement strategy, the customer could finally begin approaching target participants more effectively.

CASE STUDY

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TIMELINE
4 Months
THERAPEUTIC AREA
Alzheimer’s Disease
LOCATIONS
GA, AL, MS, TN, SC, NC

Ready to Acclinate your approach to recruitment?

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In mid-2022, Lightship partnered with Acclinate to increase African American representation in a phase 3 clinical trial for Alzheimer’s disease. Recognizing the need for a more diverse participant pool, the Lightship team engaged Acclinate’s expertise. The engagement spanned 4 months, and during this period, Acclinate aimed to double the number of pre-screened African Americans that Lightship had reached in the prior 12 months (43 people in total).

Lightship leveraged Acclinate’s three-staged approach, which combines community engagement through NOWINCLUDED with the predictive analytics tool, e-DICT. Lightship pre-screened 164 potential patients, and 157 of them identified as Black or African American. Acclinate’s efforts identified 86 patients who were eligible for screening.
3.8x
Acclinate’s increase in total pre-screened patients, accomplished in a third of the time
39.2%
Of those who passed the prescreener answered a call from Acclinate expressing interest in participating, up from 18.4% from the CRO.
86
Community members were deemed eligible for further screening through Acclinate’s efforts.
Sometimes, people do not know how to gain access to clinical trials. Our partnership with Acclinate leverage[d] their established, trusted community connections, digital platform, and app with Lightship’s robust clinical trial infrastructure and commitment to meeting participants where they are to deliver their clinical trial.
— David MacMurchy, Lightship CEO
SITUATION

Marketing Misleads Mothers

The breast milk substitute (BMS) industry is known to mislead the public regarding the value of their baby formula products.

The WHO and UNICEF published a report on how aggressive marketing has pushed mothers and health providers away from the benefits of breastmilk in favor of the unproven benefits of formula milk.1 It is common for BMS manufacturers to promise qualities “closer to/inspired by” breastmilk, despite containing synthetic, lab-made ingredients.2

However, breastfeeding is not feasible for some mothers, including those undergoing cancer treatment, those with HIV/AIDS, or those using illicit substances.3 Organic BMS formula creators are now seeking to fill these mothers’ needs in an open and industry-regulated way. This way of operating implies transparent ingredient lists, rigorous testing, and the pursuit of FDA approval.

The clinical trial industry has changed to expect trial populations to represent all races and ethnicities. In the US, this remains a difficult task. There are many historical, cultural, and institutional barriers to diverse clinical trial recruitment. Mistrust is often higher for guardians of infants.

Infant nutrition has become part of the health equity conversation because non-Hispanic Black women and Hispanic women have more barriers to breastfeeding postpartum.4 For those who cannot breastfeed, a proven BMS becomes their best option.
CHALLENGE

Low Participation

In early 2021, a customer tasked Acclinate with helping them recruit participants for an organic infant formula trial. Again, diversity was essential to the primary investigator and executive leaders. However, the customer’s decentralized trial was suffering low participation, despite having traveling nurses available in 12 different large cities at the time.

The customer anticipated difficulty recruiting diversely from their target demographic: pregnant women due less than two weeks after enrollment. In addition, the large trust gap between communities of color and the healthcare industry made diverse recruitment even less likely. Acclinate proposed a pilot program to assess and improve the customer recruitment process. With Acclinate’s targeted engagement strategy, the customer could finally begin approaching target participants more effectively.
APPROACH

Identify. Engage. Ask.

Acclinate identified a lack of trust, interest, and awareness in the customer’s organic infant formula trial. To establish trust, Acclinate planned a three-phase engagement strategy:
PHASE I: Identify
Acclinate assessed the population demographics near each site and identified where engagement would be the most effectively implemented. The ideal personas were mothers and infant care groups interested in organic living.
PHASE II: Engage
Acclinate developed new marketing materials that better resonated with the target participants and showed the customer’s dedication to serving the community. In addition, Acclinate contacted interest groups, industry professionals and subject matter experts to help tailor and distribute digital content.
PHASE III: Ask
Acclinate distributed I RB-approved digital ads to residents near the customer’s sites. These ads linked to a landing page for the customer’s organic infant formula trial. Interested participants submitted their basic demographics and contact information. Then, a trial coordinator would contact the participant to arrange a screening.

Throughout the engagement campaign Acclinate tracked the number of impressions leads and referrals that the campaign generated. In addition, the customer also provided feedback, participants survey responses, and enrollment data.
RESULTS

Acclinate’s Impact

The customer made several significant administrative changes that created lengthy delays. As a result, Acclinate’s engagement campaign was only in phase III for 60 days. Those 60 days proved to be fruitful, resulting in:
93k+
unique impressions
1200+
clicks per day
42%
increase in participant screenings
References

1. https://wvvw.who.int/publications/i/item/9789240044609
2. https://www.firststepsnutrition.org/reviews-of-claims
3. https://www.news-medical.net/health/When-Should-l-Not-Breastfeed-My-Baby.aspx
4. https://onlinelibrary.wiley.com/doi/full/10.1111/mcn.13093